This appeal focuces on the patentability of dextrorotatory ('265) in view of its known racemate described in earlier Sanofi ( '596).
The clain at issue was claim 3. DC had identified the liitations stated in claim 3 of the '265 patent as (a) the bisulfate salt (b) dextrorotatory isomer (c) the compound MATTPCA (d) substantially separated from the levoisomer. The references Apotex relied on were '596 patent and its canadian counterpart CA'875. DC had ruled that these prior arts show clopidogrel only as a racemate and do not show the separated isomer or the bisulfate salt thereof. Apotex argued that these properties are inherent, althou the references do not teach how to separate isomers, each detail is not required because POSA will know the existing methods for separation.
FC however stated that this is not the correct view of the law of anticipation which requires specific description as well as enablement of the subject matter of issue. To anticipate a reference must not only disclose the all elements of the claim in the four corners of the prior art reference but must also disclose those elements arranged as in the claim.
A generic disclosure is not necessarily a disclosure of every species that is a member of the genus.
General statements that these compounds exists as isomers cannot be considered as an anticipating disclosure of the separated dextrotatory isomer of clopidogrel as per the DC.
While considering In re Petering and In re Schaumann, the court pointed out that in both these cases the generic disclosured identified " specific preferences" which were met by the later described species.
To distinguish the case from In re Anderson the court stated that the case dealt with obviousness and did not suggest a previously unseparated and unknown enantiomer might be deemed anticipated by the known isomer.
With respect to enablement DC had held that the asserted references are not enabling for they contan no guidance as to how to separate the enantiomers of clopidogrel. Absent such evidence undue experimentation would be required. Apotex argued that it is entitled to a presumption of enablement because the asserted references are patents , which are presumed to be enablong because they are presumed to be valid ( Amgen Inc vs Hoechst Marion Roussel Inc 314.F.3d, 1313, 1355)
DC found that the prior art patents merely state that if desired enantiomers could be separated, they contained no descriptions as to how to separate the enantiomers.
While addressing obviousness DC had assumed that Apotex had made a prima facie case of obviousness. Upon consideration of Graham factors the court held that the unpredictability and unusual properties of the dextro isomer and the therapeutic advantages provided therein weighed in the factor of nonobviousness.
Apotex asserted that Sanofi's previous of PCR4099 as a promising replacement to ticlopidine wuld have led a POSA to start with PCR4099 as a lead compound. Seoaration to isomers can be carried out by techniques well known in the art.
Expert testimonials during the trial had indicated that no know scientific principle allows prediction of the degree to which stereoisomers will exhibit different levels of therapeutic activity and toxicity.
On the basis of this trial evidence DC found that a POSA would not have reasonably have predicted that the dextrorotatory enantiomer would provide all of the antiplatelet activity and none of the adverse neurotoxicity. Clear error has not been shown in this finding and in the consluion of nonobviousness based thereon. Apotex had also argued that Sanofi had followed a know process for separation. DC observed that in 1987 , there were atleast 10 techniques that had been used to separate enantiomers and they all required experimentation to determine whether they could be successful for a particular compound, including choices of reagents, solvents, concentrations, temperature etc.,
The court observed that Pasteur's diasteriomeric salt formation technique had long been described in text books, but the textbooks also explain that the method is difficult and that there no "infallible recipe" for obtaining separation. DC found that this sepration is not a simple routine separation. Apotex had not shown any prior ats teahcing separation of analogous compounds. The court described the separation as a "paradigm of trial and error" and found that neither the chemist at Sanofi nor a person of ordinary skill in the art could have reasonable expected that the separate isomers could be otained at the time that Sanofi was contemplating wheher to investigate them and if obtained , they could not have predicted by what method and configuration. Court determined that only with hindsight knowledge that the dextro isomer has highly desirable properties, can Apotex argue it wuld have been obvious to select this particular racemate and undertake the arduous separation. The application of hindsight is inappropriate where the prior art does not suggest that this isomer could reasonably be expected to manifest the advantages and properties that were found for this Dextro isomer. Regarding bisulphate salt, the court distinguished this case from Pfizer vs Apotex in that in Pfizer case there was evidence that based on prior art a POSA would have narrowed the possible salts to only a few including the claimed besylate salt. In this case Sanofi showed that the prior art taught away from use of sulfuric acid with an enantiomer , for strong acids could encourage re-racemization.
Plavix, sold by Bristol-Myers in the U.S. under an agreement with Sanofi, last year regained its title as the world’s second- best-selling drug, behind Pfizer Inc.’s Lipitor, with $8.1 billion in global sales. The drug first gained regulatory approval in 1997.
The Apotex copies cost from $1.45 billion to $1.75 billion in lost sales, Bristol-Myers said Feb. 22 in a regulatory filing. Under the failed agreement, Bristol-Myers and Sanofi can’t ask for compensation of more than 70 percent of net lost sales and waived their right to ask the judge to triple the damages because of willful infringement, Sanofi said in an Aug. 8, 2006, statement.
Six Months’ Supply
When the agreement was rejected by U.S. regulators and state attorneys general, Apotex began selling a generic version until it was ordered to stop by U.S. District Judge Sidney Stein in New York. During a three-week period, the company shipped about six months’ worth of the medicine.
In an August 2006 interview, Apotex’s Sherman said he expected the agreement to be rejected by regulators, and signed the agreement in order to wring concessions, including the limit on damages.
Bristol-Myers rose $1.06, or 4.9 percent, to $22.51 at 4:15 p.m. in New York Stock Exchange composite trading. Sanofi American depositary receipts, two of which represent one ordinary share, rose 87 cents to $29.78.
The case is Sanofi-Synthelabo v. Apotex Inc., 2007-1438, U.S. Court of Appeals for the Federal Circuit (Washington). The lower case is Sanofi-Synthelabo v. Apotex Inc., 02cv2255, U.S. District Court, Southern District of New York (Manhattan).
For quick reference the cases in Australia and Canada are provided below:
In a recent decision by the Federal Court of Australia, Justice Gyles found that certain claims of Sanofi-Aventis’ (Sanofi) Australian Patent AU 597784 (AU 784) relating to the dextro-rotatory isomer of methyl alpha-5 (4,5,6,7 - tetrahydro (3,2-c) thioeno pyridyl) (2-chlorophenyl)-acetate (clopidogrel) were invalid for lack of novelty and lack of inventive step. Despite this finding however, claims relating to specific salts of the isomer were found to be novel and not obvious and consequently, were found valid.
Background
Prior to filing AU 784 in Australia in 1988, Sanofi had filed a French patent application for racemic methyl alpha-5 (4,5,6,7 - tetrahydro (3,2-c) thioeno pyridyl) (2-chlorophenyl)-acetate, a chiral molecule (the French Patent).
Chiral molecules comprise two distinct forms of non-super imposable mirror images, known as enantiomers. Synthesis of chiral compounds ordinarily results in a mixture of equal amounts of the two enantiomers, called a “racemic mixture” or a “racemate”. One enantiomer, the levo or (-) enantiomer, rotates plane polarised light to the left, and the other, the dextro or (+) enantiomer, rotates plane polarised light to the right. This property can, however, only be identified when the enantiomer is separated from the racemic mixture. Enantiomers commonly have different biological activities because of their different interactions with other enantiomeric molecules in the body.
In Australia, Sanofi markets Plavix, a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. The active ingredient in Plavix is clopidogrel bisulfate (hydrogen sulfate), which is a salt of the enantiomer covered by the claims of AU 784.
The patents
AU 784 claimed the dextro (+) enantiomer, a process for its preparation, the pharmaceutical composition containing it and specified salts (hydrochloride, hydrogen sulphate, hydrobromide and taurochlorate) thereof. Reportedly, the (+) enantiomer had more activity and lower toxicity than the levo (-) enantiomer. The French Patent specifically described each enantiomer of the racemic mixture as well as the racemic mixture itself. Significantly, AU 784 also claimed pharmaceutically acceptable salts of the (+) enantiomer.
The proceedings
Apotex (formerly GenRx Pty Ltd) commenced proceedings against Sanofi in 2007 seeking revocation of AU 784 on several grounds, including that the claims of AU 784 were not novel and were obvious in light of the French Patent. Apotex also claimed that the patent was invalid on the grounds of false suggestion or misrepresentation, inutility, and that the claimed invention was not a manner of manufacture.
Lack of novelty
Sanofi argued that AU 784 was not invalid for want of novelty because the French Patent prior art relied on by Apotex was not an enabling disclosure of the (+) enantiomer. Justice Gyles accepted that, in relation to process claims, an alleged anticipation must contain “clear instructions to do or make something” that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent. However, in relation to a product claim, there must only be a “clear description of something” that would infringe the patentee’s claim if carried out after the grant of the patentee’s claim.
Here, it was found that the earlier French Patent gave Sanofi a monopoly in relation to the making and using of the disclosed racemate and each of its enantiomers, either together or separately. Similarly, Justice Gyles found that the existence and the advantages of each of the enantiomers, as well as those of the racemic mixture, were clearly disclosed in the French Patent. Importantly, Justice Gyles stated that “no doubt, if only the racemate were claimed, there would be a large risk that this would not protect against competition from a drug with one of the enantiomers as the active ingredient”.
Justice Gyles distinguished this case from the situation in Alphapharm Pty Ltd v H LunbeckA/S [2008] FCA 559 (a decision which has been appealed to the Full Court) where there was no express reference to, or claim to, the enantiomers of the racemate in the prior art. In that case Justice Lindgren found that a skilled addressee would understand that the (+) enantiomer of citalopram exists when it is contained in the disclosed racemate, however, for an alleged anticipation to be an “enabling disclosure”, it must point unmistakeably to the enantiomer as distinct from the racemate, as a desirable drug to obtain. In Lindgren J’s opinion the prior art patent claiming the racemic mixture of citalopram did not refer to, or disclose, by implication or otherwise, the existence of the two enantiomers.
Here, Justice Gyles found that the French Patent expressly disclosed the existence of the two enantiomers as having the claimed advantage. Consequently, the French Patent was found to anticipate AU 784 , unless AU 784 could be viewed as a selection patent.
Justice Gyles indicated that selection patent principles set out in Re IG Farbenindustrie AG’s Patent (1930) 47 RPC 289 apply to a patent where a compound claimed is specifically identified in an earlier specification as a member of a larger class, not merely where there is express identification for the first time, of a particular member of a larger class with the special characteristic. Justice Gyles stated that a patent application will overcome a prior publication as a selection patent if:
there is some substantial advantage to be secured by use of the selected members of a class,
the whole of the selected members possess the advantage,
the selection is in respect of a quality of a special character, which can fairly be said to be peculiar to the group, and
the advantage possessed by the selected members is clearly disclosed in the specification.
Here, it was found that there was substantial advantage to be secured by the use of the (+) enantiomer when compared to the use of either the racemic mixture or the (-) enantiomer and the whole of the (+) enantiomer class of compounds possessed the advantage. Similarly, the advantage was clearly disclosed. However, His Honour did not accept that the advantage gained was the inventor’s own discovery, but was rather a verification of previous predictions in the French Patent that the enantiomers would not have equal qualities. Consequently, claims of AU 784 relating to the (+) enantiomer per se were not capable of being a valid selection from the compounds described in the French Patent.
Despite finding the (+) enantiomer was anticipated by the French Patent, Justice Gyles found that, significantly, the salts of the (+) enantiomer claimed in AU 784 were not clearly described in the French Patent. Consequently, claims 2, 3, 4 and 5 relating to the salts of the (+) enantiomer were not found to have been anticipated.
Lack of inventive step
Justice Gyles acknowledged that an inventive step does not have to be a “flash of genius” but that there must be a step from one thing to another. In deciding whether AU 784 disclosed an inventive step, His Honour applied the test of whether a hypothetical addressee, when faced with the same problem, would have taken as a matter of routine, whatever steps led from the prior art to the invention.
Although generally the starting point for analysis of inventive step is what was in the common general knowledge at the relevant time, because the enantiomer had been previously disclosed in the prior art, the Court looked at the inventive step described in the specification of the patent in suit.
Sanofi argued that the claimed invention was ascertaining that only the (+) enantiomer exhibited platelet aggregation inhibiting activity and that the (-) enantiomer was inactive and less tolerated and that this was not obvious. However, Gyles J held that it was common general knowledge in Australia at the priority date that one of the two enantiomers might contain all of the activity and “the discovery of that characteristic in this case was not so unexpected as to amount to an inventive step”.
Justice Gyles next turned to assessing the inventiveness of the salts of the claimed enantiomer. His Honour said that if the starting point for assessing inventiveness is the single (+) enantiomer, then the salt of the enantiomer would be obvious. However, the inventive step claimed in relation to the salts was not the method of obtaining the salts, but rather the identification of the properties of the salts obtained. Consequently, the claims to specific salts were found to involve an inventive step when compared with the common general knowledge in Australia at the relevant time (which did not include clopidogrel). Unlike the enantiomer claims, the salts were novel compounds without any consideration as selection patents and therefore inventiveness was to be viewed from the starting point of what was common general knowledge.
As a result, while claims of the patent relating to the (+) enantiomer were found to lack novelty and inventive step, claims to specified salts of the (+) enantiomer, including the active ingredient in Sanofi’s product Plavix, the hydrogen sulphate salt, were found to be valid. The Court also rejected Apotex’s arguments that these claims were invalid on the grounds of false suggestion or misrepresentation, inutility, and that the claimed invention was not a manner of manufacture.
Claims to the process of resolving the enantiomers from the racemic mixture were found to be invalid on the ground of obviousness, as the process claimed was routine.
Comment
This case raises the difficult issue of when an Australian patent can be treated as a selection patent. If it is to be treated as a selection patent, does a different obviousness test apply? The question identified by Justice Gyles at para [80], of whether a valid selection patent can exist if the compound claimed was specifically identified in the first patent as a member of a larger class, remains to be definitively resolved.
Canada case:
On November 6, 2008, in Apotex Inc. v. Sanofi-Synthelabo Canada Inc.,1 the Supreme
Court of Canada unanimously confirmed that a selection patent (described as a patent
whose subject matter is a fraction of a larger known class of compounds that was the
subject matter of a prior patent) is permissible under the Canadian Patent Act. Indeed,
the Court confirmed that a selection patent “does not in its nature differ from any
other patent,” and its validity should be evaluated by the usual statutory criteria, such
as novelty and inventiveness. The Court also refined the tests for these important
prerequisites to patentability.
Facts
The selection in this Sanofi case was clopidogrel bisulfate, marketed as Plavix. The
invention was the selection of clopidogrel and its bisulfate salt. A prior patent disclosed
a class of compounds that included clopidogrel, but not its beneficial properties, which
include enhanced inhibition of platelet aggregation (clotting) and a superior toxicity
and tolerability profile. The prior patent also did not disclose the benefit of the
bisulfate salt, which was found to have superior properties over other salts.
Earlier Decisions and the Selection Patents Controversy
Apotex argued that the patent for clopidogrel bisulfate was invalid for lack of novelty,
obviousness and double patenting, because it had been disclosed generically in the
prior patent. The lower courts disagreed, finding that it was a valid selection from the
previous class. Apotex appealed to the Supreme Court, asking it to abolish selection
patents altogether. The Court refused, holding that an inventor who makes and
discovers the special advantages of a member of a class should be entitled to a patent
for that member. The Court then considered the validity of the clopidogrel bisulfate
patent in light of Apotex’s validity attacks: anticipation, obviousness and double
patenting. In doing so, the Court refined the law for each of these requirements.
Anticipation
The Court noted two requirements for the test for anticipation: prior disclosure and enablement. The test is not simply whether “the exact invention has already been made and publicly disclosed.”
“Prior disclosure” means that the prior patent must disclose subject matter that, if performed, would necessarily result in infringement of that patent. At this first stage, the skilled reader must find a disclosure: the skilled person cannot say that there would be a disclosure with some trial and error or experimentation. The skilled person is simply reading the prior patent to understand and try to find the disclosure of the invention – and not as a precursor. Most importantly in the context of selection patents, if the genus patent does not disclose the special advantages of the invention covered by the selection patent, the disclosure requirement is not met and the selection patent is therefore not anticipated by the genus patent.
“Enablement” means that the person skilled in the art would have been able to perform the subject matter of the prior art constituting the asserted anticipation. For purposes of enablement, the question is not what the skilled person would think the disclosure of the prior patent meant, but whether he or she would be able to work the subject matter. The Court asked itself, how much trial and error and experiment is permitted at the enablement stage? The answer: the prior patent must provide enough information to allow the subsequently claimed invention to be performed without “undue burden.” Routine trials are acceptable, but inventive steps are not permitted. If inventive steps are required, the prior art will not be considered enabling.
The Court concluded that since the genus patent in this case did not disclose the special advantages of the dextro-rotatory isomer and of its bisulfate salt, the invention of the selection patent was not disclosed and therefore was not anticipated.
Obviousness
The Court began its obviousness analysis with the well-known test in Beloit: whether the skilled person, in light of the state of the art and common general knowledge, would have come directly and without difficulty to the solution taught by the patent. Since Beloit, lower courts had explicitly rejected an “obvious to try” approach. Because both the United States and United Kingdom have accepted a (stringent) version of an “obvious to try” test, the Court examined the question whether it might be appropriate, in certain circumstances, to use a similar standard in Canada.
Noting that “obvious to try” is not a mandatory test in the United States and United Kingdom, the Court stated that it must be approached cautiously. The Court concluded that in Canada, it is not sufficient if an invention was simply “obvious to try;” rather, an invention would be obvious when it is “more or less selfevident that what is being tested ought to work.” The mere possibility that something might turn up is
simply not enough. Moreover, the Court was clear that the “obvious to try” inquiry is but one factor to assist in the obviousness inquiry, which becomes relevant only in narrow circumstances. The invention must still be self-evident from the prior art and common general knowledge to satisfy the obviousness test.
On the facts of this case, the Court held that Apotex had not established obviousness.
Double Patenting
Apotex argued that a genus patent and selection patent covering the same compound necessarily
amounted to double patenting. The Court rejected this argument, stating that a generalized concern about evergreening does not justify an attack on the doctrine of selection patents. The reasons are two-fold: first,a selection patent may be sought by a party other than the inventor or owner of the original genus patent.
Second, selection patents encourage improvements by selection. The Court agreed that the focus in a double-patenting challenge is on the claims of the two patents rather than on the disclosure. Because theclaims of the genus patent are broader than those of the selection patent, there cannot be “same-type”double patenting. Furthermore, where a selection patent claims a compound that is patentably distinctfrom the genus patent (i.e., not obvious), it will not be invalid for obviousness double patenting.
On the facts of this case, the Court found that there was no double patenting.
Friday, December 12, 2008
Wednesday, December 10, 2008
Lobbying against biogenerics
What did BIO, Genentech, Biogen Idec and other biotech drugmakers spend money on last quarter? Lobbying, of course. BIO, the industry's advocacy group, spent $1.9 million lobbying Congress on a variety of issues, including patent reform, stem cells, reimbursement and biogenerics. The lack of generic drug competition has been a major boon for biotech companies since they don't have to worry about patent expiration and generic competition the way pharmaceutical companies do. But that may be changing. With a new President headed for the White House, the previously-stalled efforts to create a faster biogeneric approval pathway will probably be revived. Biotech drugs are generally far more expensive than pharmaceuticals, which won't escape the notice of an administration focused on cutting high healthcare costs. The biotech industry is hoping for the best--but preparing for the worst.
For example, Genentech and Biogen Idec forked over $570,000 and $180,000 respectively in Q3 lobbying against biogeneric drugs. And last week, we reported that Amgen and Amylin Pharmaceuticals spent big bucks on the same issue. As the calls for healthcare reform heat up, so will Biotech's efforts to prevent generic competition that has caused many a headache for pharma execs.
For example, Genentech and Biogen Idec forked over $570,000 and $180,000 respectively in Q3 lobbying against biogeneric drugs. And last week, we reported that Amgen and Amylin Pharmaceuticals spent big bucks on the same issue. As the calls for healthcare reform heat up, so will Biotech's efforts to prevent generic competition that has caused many a headache for pharma execs.
Patent pledge to Indian universities
India's parliament will soon be scrutinizing a bill intended to help publicly funded institutes and universities commercialize their research. India's science minister, Kapil Sibal, is confident that the bill will become law and will help Indian universities "make millions through patents".But the bill has been pushed through without an open debate and is not publicly available, prompting concern. "In a democracy you cannot bulldoze a bill like this," says Pushpa Bhargava, former vice-chair of the National Knowledge Commission.
The idea is widely believed to be the brainchild of Raghunath Mashelkar, former director-general of the Council of Scientific and Industrial Research (CSIR), who has turned his own labs into veritable patent factories (see Nature 442, 120; 2006). After the knowledge commission backed the move in 2007, the government asked the Department of Biotechnology to draft wording for the bill, which the Indian cabinet approved on 31 October. It had been slated to go before a parliamentary committee this month, but the Mumbai terror attacks may cause it to be pushed into early 2009.
The bill is modelled on the 1980 US Bayh–Dole Act, which allowed US universities topatent discoveries derived from federally funded work. According to the Indian bill, scientists would be allowed to retain 30% of the net income earned from patents and licences. The scientist's institute would retain 40%, with the rest going into a fund maintained by the institute for managing intellectual property. Researchers in publicly funded institutes or universities would also be allowed, for the first time, to set up and work in private companies without having to leave their academic jobs.
"The benefits of publicly funded research are not reaching the public," Sibal told a meeting of the Federation of Indian Chambers of Commerce and Industry (FICCI) in October. "We need to create an environment in which wealth can be generated from the university system."
Only a few top institutes in India have a good grasp of patents and markets. Between 1990 and 2002, Indian universities accounted for only 3% of patents filed by Indian organizations in the Indian patent office, and 1% of Indian patents filed in the US patent office, according to the New Delhi-based National Institute of Science, Technology and Development Studies. Researchers at institutes without a well-developed technology-transfer office can apply to the National Research Development Corporation in New Delhi for help in commercializing their work.
Heads of publicly funded institutes support the bill in principle. "This will empoweruniversities in an era of patents and competitiveness," says Samir Brahmachari, director general of the CSIR. But he notes that scientists and institutes also need to strike a balance between earning profits and keeping the public interest in mind, especially in fields such as affordable health care and infectious diseases.
Most university academics have not read the bill, and their opinions on the initiative are mixed. Some welcome it, saying it will increase awareness of patenting. Others are concerned that teaching and basic research might get sidelined.
Indian industry is enthusiastic about the move. Amit Mitra, the FICCI's secretary general, argues that the Bayh–Dole Act helped US universities earn revenue from key discoveries, such as the anti-AIDS drug stavudine at Yale University and recombinant-DNA technology at the University of California and Stanford University.But some analysts say that the US model cannot be replicated in India, where most universities are hampered by poor funds and outdated infrastructure, and where fewer students are choosing to take up science. "Many students end up doing neither frontline basic science nor applied technology, and fall in-between with mediocre work," notes Ashok Parthasarathi, former science adviser to the Indian government. He says the bill is both "impractical andinfeasible" to implement, specifying what he calls "absurd time periods". The university or laboratory in question would need to notify the government about patentable results within 60 days of realizing the patent potential, and indicate within 90 days the countries it would file patent in.
"One should not expect Indian universities to have an instant capacity to file and maintain patents, follow up on infringements, and negotiate technology transfers," adds Krishna Ravi Srinivas, an associate fellow at the New Delhi-based Research and Information System for Developing Countries. Still, he says, "a beginning has to be made somewhere, and Bayh–Dole is the best model we have".Within the past few years, China, Brazil, Malaysia and South Africa have passed Bayh–Dole-type laws, hoping to capitalize on their research. But some experts argue that this approach may not work in developing countries.
Bhaven Sampat, an economist at Columbia University in New York City and co-author of a recent study on the subject (A. D. So et al. PLoS Biol. 6, e262; 2008), argues that Bayh–Dole did not significantly affect the commercialization of US academic research. He cites 2006 data from the Association of University Technology Managers that suggest US universities, hospitals and research institutions derived $1.85 billion from technology licensing — less than 5% of the money they received from federal, state and industry funders.
The idea is widely believed to be the brainchild of Raghunath Mashelkar, former director-general of the Council of Scientific and Industrial Research (CSIR), who has turned his own labs into veritable patent factories (see Nature 442, 120; 2006). After the knowledge commission backed the move in 2007, the government asked the Department of Biotechnology to draft wording for the bill, which the Indian cabinet approved on 31 October. It had been slated to go before a parliamentary committee this month, but the Mumbai terror attacks may cause it to be pushed into early 2009.
The bill is modelled on the 1980 US Bayh–Dole Act, which allowed US universities topatent discoveries derived from federally funded work. According to the Indian bill, scientists would be allowed to retain 30% of the net income earned from patents and licences. The scientist's institute would retain 40%, with the rest going into a fund maintained by the institute for managing intellectual property. Researchers in publicly funded institutes or universities would also be allowed, for the first time, to set up and work in private companies without having to leave their academic jobs.
"The benefits of publicly funded research are not reaching the public," Sibal told a meeting of the Federation of Indian Chambers of Commerce and Industry (FICCI) in October. "We need to create an environment in which wealth can be generated from the university system."
Only a few top institutes in India have a good grasp of patents and markets. Between 1990 and 2002, Indian universities accounted for only 3% of patents filed by Indian organizations in the Indian patent office, and 1% of Indian patents filed in the US patent office, according to the New Delhi-based National Institute of Science, Technology and Development Studies. Researchers at institutes without a well-developed technology-transfer office can apply to the National Research Development Corporation in New Delhi for help in commercializing their work.
Heads of publicly funded institutes support the bill in principle. "This will empoweruniversities in an era of patents and competitiveness," says Samir Brahmachari, director general of the CSIR. But he notes that scientists and institutes also need to strike a balance between earning profits and keeping the public interest in mind, especially in fields such as affordable health care and infectious diseases.
Most university academics have not read the bill, and their opinions on the initiative are mixed. Some welcome it, saying it will increase awareness of patenting. Others are concerned that teaching and basic research might get sidelined.
Indian industry is enthusiastic about the move. Amit Mitra, the FICCI's secretary general, argues that the Bayh–Dole Act helped US universities earn revenue from key discoveries, such as the anti-AIDS drug stavudine at Yale University and recombinant-DNA technology at the University of California and Stanford University.But some analysts say that the US model cannot be replicated in India, where most universities are hampered by poor funds and outdated infrastructure, and where fewer students are choosing to take up science. "Many students end up doing neither frontline basic science nor applied technology, and fall in-between with mediocre work," notes Ashok Parthasarathi, former science adviser to the Indian government. He says the bill is both "impractical andinfeasible" to implement, specifying what he calls "absurd time periods". The university or laboratory in question would need to notify the government about patentable results within 60 days of realizing the patent potential, and indicate within 90 days the countries it would file patent in.
"One should not expect Indian universities to have an instant capacity to file and maintain patents, follow up on infringements, and negotiate technology transfers," adds Krishna Ravi Srinivas, an associate fellow at the New Delhi-based Research and Information System for Developing Countries. Still, he says, "a beginning has to be made somewhere, and Bayh–Dole is the best model we have".Within the past few years, China, Brazil, Malaysia and South Africa have passed Bayh–Dole-type laws, hoping to capitalize on their research. But some experts argue that this approach may not work in developing countries.
Bhaven Sampat, an economist at Columbia University in New York City and co-author of a recent study on the subject (A. D. So et al. PLoS Biol. 6, e262; 2008), argues that Bayh–Dole did not significantly affect the commercialization of US academic research. He cites 2006 data from the Association of University Technology Managers that suggest US universities, hospitals and research institutions derived $1.85 billion from technology licensing — less than 5% of the money they received from federal, state and industry funders.
European patent application no EP 2 000 000
The European Patent Office (EPO) has reached a milestone today by publishing its two millionth patent application. The application, filed on 7 June 2007 by the Technical University of Denmark (DTU) in Lyngby, describes a microbial fuel cell which can be used to produce electricity from wastewater.
A microbial fuel cell is an electrochemical device that enables the bioconversion of chemical energy from organic matter directly into electrical energy with the help of microorganisms as catalysts. It can produce electricity from wastewater, thus helping to reduce dependency on fossil fuels. At the same time, it contributes to the degradation of the pollutants contained in wastewater.
Although microbial fuel cells are already in use, the patent applied for by DTU's researchers makes a claim to an improved method for its construction.
"The EPO is pleased to see that this symbolic publication number is attributed to a patent application coming from a European university in such a relevant technology," said EPO President Alison Brimelow. "It should be borne in mind, however, that high application figures should generally not be misread as indicating high levels of innovation, but are in the first place a consequence of increased global competition among technology providers."
Applications for European patents are published 18 months after first filing. They are examined by panels of three scientists with expertise in their technical field to ensure they meet the strict requirements of the European Patent Convention in order to be granted. The present application is in examination, and no decision has been taken yet if a patent can be granted.
The EPO received its first application in 1978. The one millionth application was published in 2000.
A microbial fuel cell is an electrochemical device that enables the bioconversion of chemical energy from organic matter directly into electrical energy with the help of microorganisms as catalysts. It can produce electricity from wastewater, thus helping to reduce dependency on fossil fuels. At the same time, it contributes to the degradation of the pollutants contained in wastewater.
Although microbial fuel cells are already in use, the patent applied for by DTU's researchers makes a claim to an improved method for its construction.
"The EPO is pleased to see that this symbolic publication number is attributed to a patent application coming from a European university in such a relevant technology," said EPO President Alison Brimelow. "It should be borne in mind, however, that high application figures should generally not be misread as indicating high levels of innovation, but are in the first place a consequence of increased global competition among technology providers."
Applications for European patents are published 18 months after first filing. They are examined by panels of three scientists with expertise in their technical field to ensure they meet the strict requirements of the European Patent Convention in order to be granted. The present application is in examination, and no decision has been taken yet if a patent can be granted.
The EPO received its first application in 1978. The one millionth application was published in 2000.
274 Product Patent Cases Recorded In Malaysian Court
PENANG, Dec 2 (Bernama) -- The High Court's Intellectual Property Division has recorded 274 cases involving product patents during the first eight months of the year, compared with 142 cases for the corresponding period last year.Intellectual Property Corporation of Malaysia (MyIPO) director-general Kamel Mohamad said 91 of the cases had been solved.He said the media, universities and government agencies needed to play a bigger role in helping inventors protect their products from being copied by irresponsible individuals."The issue of copying products is caused by a lack of awareness in this country about the importance of product patents, compared with other countries," he said.He said told reporters after launching the International Conference on Electronic Design (ICED 2008) here Tuesday.The three-day conference, organised by UniMAP, brings together 100 participants, including those from Singapore and the United States, to discuss various issues regarding electronic technology as well as opportunities and challenges in overcoming problems in the field.Kamel said MyIPO was responsible for monitoring the development and management of the intellectual property system, which comprises patents, logos, industrial designs, copyrights and invention protection in Malaysia."We have carried out many awareness programmes to encourage more Malaysians to apply for patents and prevent their ideas from being copied," he said.Kamel stressed that with a patent, each inventor could ensure maximum returns from his research and development through royalties once the product is commercialised.He said there were currently 21 Intellectual Property Courts comprising 15 Sessions Courts and six High Courts (Intellectual Property Division) nationwide."The setting up of these courts is a clear indication that the government is serious about protecting the intellectual property of individuals," he said.-- BERNAMA
United States: Reduction Of Compensatory Damages Requires Offer Of New Trial By Jury-Article by Leigh J. Martinson
The U.S. Court of Appeals for the Federal Circuit recently vacated a judicial reduction in damages for violating the Seventh Amendment, while affirming a jury's finding of infringement of a means-plus-function claim by applying well-known precedent. Floyd M. Minks v. Polaris Industries, Inc., Case Nos. 07-1490, -1491 (Fed. Cir., Oct. 17, 2008) (Gajarsa, J.).
Floyd M. Minks is an electrical engineer who designs electronic components for a variety of vehicle types. Minks holds U.S. Patent No. 4,664,080 (the '080 patent), which is drawn to an electric governor system for internal combustion engines that uses a circuit to limit the reverse speed of an all-terrain vehicle (ATV). When the ATV is shifted into reverse gear, the reverse speed limiter circuit senses the direct current (DC) voltage. Once activated, the circuit also senses the alternator's alternating current (AC) output to thereby sense engine speed. If the alternator's AC voltage output exceeds a predetermined limit, the circuit emits a control signal to interrupt the ignition of the engine. Minks sued Polaris, a customer for years, for infringement of the '080 patent after making numerous attempts to obtain a license from Polaris for its use of a reverse-speed limiter produced by a different vendor. The only asserted claim was claim 2, which included means-plus-function elements.
The jury found willful infringement and awarded just under $1.3 million in royalty damages. The district court subsequently granted Polaris' motion for a reduction in damages or remittitur pursuant to Rule 59(e). The court reduced the jury's damages award to $27,904.80, an amount which was later double based on the willfulness finding. The court failed to offer Minks a new trial on damages, holding that reduction was necessitated by legal error. Minks appealed the reduction of the damages award, among other things. Polaris cross-appealed from the district court's denial of its judgment as a matter of law (JMOL) motion on non-infringement.
The Supreme Court has long interpreted the Seventh Amendment as requiring that the exercise of a district court's discretion to set aside an excessive jury award be accompanied by an offer of a new trial. However, in the Eleventh Circuit, when a jury's award is premised on "legal error," a court may reduce the award and enter an absolute judgment in an amount sufficient to correct the legal error without offering the plaintiff the option of a new trial. The Eleventh Circuit recognizes two types of legal error that fit this situation: where a portion of a verdict is for an identifiable amount that is not permitted by law and when the award enter[s] that zone of arbitrariness that violates the due process clause of the Fourteenth Amendment.
After reviewing the facts on appeal, the Federal Circuit concluded that neither of the above exceptions applied. The Court stated, after reviewing in the district court's analysis of this award, that the district court had identified no legal principle that would limit the amount of a reasonable royalty. Thus, it was improper to reduce the award without offering Minks a new trial. As such, the Court vacated the district court's judgment and remanded for a new trial on the issue.
Also, the Court reiterated that to determine infringement of a means-plus-function claim, "the court must compare the accused with the disclosed structure, and must find equivalent structure as well as identity of the claimed function for that structure." On appeal, Polaris failed to make any argument that the accused devices did not perform a function identical to that recited in the claim to achieve an identical result. In its analysis, the Court applied the function-way-result test to determine equivalence between the accused product and the '080 patent. The Court also reiterated that differences in physical structure alone is not determinative of § 112 ¶ 6 equivalence. Rather, once the identity of function is established, the test for infringement is whether the structure of the accused device performs in substantially the same way to achieve substantially the same result as the disclosed structure. Citing both expert testimony and the '080 patent itself, the Court agreed that the jury's verdict of infringement was supported and thus affirmed.
Floyd M. Minks is an electrical engineer who designs electronic components for a variety of vehicle types. Minks holds U.S. Patent No. 4,664,080 (the '080 patent), which is drawn to an electric governor system for internal combustion engines that uses a circuit to limit the reverse speed of an all-terrain vehicle (ATV). When the ATV is shifted into reverse gear, the reverse speed limiter circuit senses the direct current (DC) voltage. Once activated, the circuit also senses the alternator's alternating current (AC) output to thereby sense engine speed. If the alternator's AC voltage output exceeds a predetermined limit, the circuit emits a control signal to interrupt the ignition of the engine. Minks sued Polaris, a customer for years, for infringement of the '080 patent after making numerous attempts to obtain a license from Polaris for its use of a reverse-speed limiter produced by a different vendor. The only asserted claim was claim 2, which included means-plus-function elements.
The jury found willful infringement and awarded just under $1.3 million in royalty damages. The district court subsequently granted Polaris' motion for a reduction in damages or remittitur pursuant to Rule 59(e). The court reduced the jury's damages award to $27,904.80, an amount which was later double based on the willfulness finding. The court failed to offer Minks a new trial on damages, holding that reduction was necessitated by legal error. Minks appealed the reduction of the damages award, among other things. Polaris cross-appealed from the district court's denial of its judgment as a matter of law (JMOL) motion on non-infringement.
The Supreme Court has long interpreted the Seventh Amendment as requiring that the exercise of a district court's discretion to set aside an excessive jury award be accompanied by an offer of a new trial. However, in the Eleventh Circuit, when a jury's award is premised on "legal error," a court may reduce the award and enter an absolute judgment in an amount sufficient to correct the legal error without offering the plaintiff the option of a new trial. The Eleventh Circuit recognizes two types of legal error that fit this situation: where a portion of a verdict is for an identifiable amount that is not permitted by law and when the award enter[s] that zone of arbitrariness that violates the due process clause of the Fourteenth Amendment.
After reviewing the facts on appeal, the Federal Circuit concluded that neither of the above exceptions applied. The Court stated, after reviewing in the district court's analysis of this award, that the district court had identified no legal principle that would limit the amount of a reasonable royalty. Thus, it was improper to reduce the award without offering Minks a new trial. As such, the Court vacated the district court's judgment and remanded for a new trial on the issue.
Also, the Court reiterated that to determine infringement of a means-plus-function claim, "the court must compare the accused with the disclosed structure, and must find equivalent structure as well as identity of the claimed function for that structure." On appeal, Polaris failed to make any argument that the accused devices did not perform a function identical to that recited in the claim to achieve an identical result. In its analysis, the Court applied the function-way-result test to determine equivalence between the accused product and the '080 patent. The Court also reiterated that differences in physical structure alone is not determinative of § 112 ¶ 6 equivalence. Rather, once the identity of function is established, the test for infringement is whether the structure of the accused device performs in substantially the same way to achieve substantially the same result as the disclosed structure. Citing both expert testimony and the '080 patent itself, the Court agreed that the jury's verdict of infringement was supported and thus affirmed.
Stanford Intellectual Property Litigation Clearinghouse
On Monday, December 8, 2008, the Law, Science & Technology Program at Stanford Law School launched the Stanford Intellectual Property Litigation Clearinghouse (IPLC), a unique online database that offers comprehensive information about intellectual property disputes within the United States
Shire LLC v. Sandoz, 07-CV-00197-PAB, December 5, 2008 (D. Co.)-Claim Construction Estoppel Heads to the CAFC
The district court issued an Order and Memorandum construing the claims in the patents at issue. In the Order, the Court declined to apply the doctrine of issue preclusion to another district court’s claim construction with respect to the same patents. Defendant moved the Court to certify the Order for immediate interlocutory appeal pursuant to 28 U.S.C. § 1292(b). Specifically, defendant requested that the Court certify two issues addressed in the Order, one of which was “whether collateral estoppel and/or stare decisis applies to a previous court’s unappealed claim construction."After further review, the district court determined that appeal to the CAFC was warranted:
The Court further finds that there is substantial ground for difference of opinion as to the application of issue preclusion to another district court’s unappealed claim construction. There is no definitive guidance from the Supreme Court, the Tenth Circuit, or the Federal Circuit on this question. District courts have reached conflicting positions. Compare, e.g., TM Patents, L.P. v. Int’l Bus. Mach. Corp., 72 F. Supp. 2d 370, 377 (S.D.N.Y. 1999) (holding that claim construction in a Markman hearing is a final judgment for purposes of issue preclusion), with Kollmorgen Corp. v. Yaskawa Elec. Corp., 147 F. Supp. 2d 464, 469 (W.D. Va. 2001) (holding that issue preclusion applies only if the earlier claim construction “was essential to a final judgment on the question of the patents’ infringement”), and Graco Children’s Prods., Inc. v. Regalo Int’l, LLC, 77 F. Supp. 2d 660, 663 (E.D. Pa. 1999) (holding that, “despite a previous court having held a hearing on the claim construction of a patent pursuant to Markman,” issue preclusion would not apply under the facts of the case). Thus, the question presents a novel legal issue whose correct resolution is not substantially guided by prior precedent, as required by 28 U.S.C. § 1292(b).
The Court further finds that there is substantial ground for difference of opinion as to the application of issue preclusion to another district court’s unappealed claim construction. There is no definitive guidance from the Supreme Court, the Tenth Circuit, or the Federal Circuit on this question. District courts have reached conflicting positions. Compare, e.g., TM Patents, L.P. v. Int’l Bus. Mach. Corp., 72 F. Supp. 2d 370, 377 (S.D.N.Y. 1999) (holding that claim construction in a Markman hearing is a final judgment for purposes of issue preclusion), with Kollmorgen Corp. v. Yaskawa Elec. Corp., 147 F. Supp. 2d 464, 469 (W.D. Va. 2001) (holding that issue preclusion applies only if the earlier claim construction “was essential to a final judgment on the question of the patents’ infringement”), and Graco Children’s Prods., Inc. v. Regalo Int’l, LLC, 77 F. Supp. 2d 660, 663 (E.D. Pa. 1999) (holding that, “despite a previous court having held a hearing on the claim construction of a patent pursuant to Markman,” issue preclusion would not apply under the facts of the case). Thus, the question presents a novel legal issue whose correct resolution is not substantially guided by prior precedent, as required by 28 U.S.C. § 1292(b).
Tuesday, December 9, 2008
Data Exclusivity for Follow-On Biologics- John E. Calfee
Data exclusivity promises to be more important for biologics than it has ever been for small-molecule drugs. Because patents of newly approved biologics may prove more open to challenge than small-molecule patents, new biologics could be subject to competition shortly after initial FDA approval if there is no period of data exclusivity. Should early patent challenges and early follow-on entry become a real possibility, such a prospect would be taken into account in planning future biologic R&D, with obvious adverse consequences for R&D investment.
The EU is farther along than the United States in dealing with follow-ons and data exclusivity. The EU has already approved several follow-on versions of older and simpler biologics and has constructed a law to govern the approval of follow-ons for newer, more complex biologics. That law provides for ten years of data exclusivity, with an additional year for new indications approved within eight years of initial approval (Grabowski 2008; Woodcock et al. 2007).
Several follow-on biologic bills have been circulated in Congress. S 1695, sponsored by Senators Edward Kennedy (D-Mass.), Mike Enzi (R-Wyo.), Orrin Hatch (R-Utah), and Hillary Clinton (D-N.Y.), would provide twelve years of data exclusivity. S 1505, sponsored by Senator Judd Gregg (R-N.H.), would provide twelve to sixteen years. HR 1956, sponsored by Representative Jay Inslee (D-Wash.) with support from the Biotechnology Industry Organization, a trade group, would provide twelve to fifteen years; HR 5629, sponsored by Representatives Anna Eshoo (D-Calif.) and Joe Barton (R-Tex.), would provide twelve to fourteen years. However, HR 1038, sponsored by Representative Henry Waxman (D-Calif.), would provide no data exclusivity at all.
The Problem of Setting Data Exclusivity Periods. How long should data exclusivity be? For years, economists have debated the analogous question for patents, arriving only at the conclusion that it all depends on many factors and that there is no reason why patent length should be the same for every industry. Nor is there a solid foundation for setting different periods for different industries. For the time being, a unitary system prevails in which the same rules apply to all industries. But data exclusivity is a tool that comes into play when patents fail to provide reasonable protection for innovation. Data exclusivity is arguably more important for modern biologics than for any other industry, and we have to think afresh about exclusivity and how it works in this unusual industry. Given the stakes--a substantial amount of future R&D hangs in the balance--Congress should exercise an abundance of caution in designing follow-on biologic legislation so as not to endanger valuable future research.
One approach to data exclusivity is to examine the record of biologics approved in the past decade or two and estimate how long it took for those products to generate profits after taking account of the time and expense of R&D and the risks of failure (DiMasi and Grabowski 2007). Working with those data and assuming that postapproval research increases financial outlays by 35 percent, Grabowski (2008) estimated payback periods of between 12.9 and 16.2 years depending on the cost of capital (which, in his model, ranged between 11.5 percent and 12.5 percent). Such results might serve as a guide to a suitable period of data exclusivity.
This approach is fraught with peril. Aside from a possibly nonrepresentative sample, the exercise involves numerous assumptions about the cost of capital, profit margins, and prices after the first follow-on enters the market. Reasonable changes to these assumptions can easily affect the results by 30-40 percent (Brill 2008). Another almost insuperable difficulty is how to take reasonable account of the financial risks in biotechnology R&D, in which most products and, indeed, most firms fail before realizing any revenues at all, not to mention profits. Furthermore, one of the most fundamental characteristics of biologics--the dominant role of postapproval R&D--is highly variable and is impossible to predict in terms of either costs or medical value. In particular, because the drugs with the most promising postapproval R&D agendas have reached the market only in the past few years, there is no way to extrapolate from recent experience in order to estimate the future volume, costs, and medical value of postapproval R&D expenditures--although it is already clear that, for many of the most valuable biologics, those expenses will be large relative to initial R&D and will continue for many years.
A Sensible Approach to Data Exclusivity
What makes sense is to rely on a few basic principles and a deep sense of caution about the threat of suppressing R&D. A signal consideration is that if Congress errs by establishing too short a period for data exclusivity, the R&D it suppresses will never be observed, nor will the products that the missing R&D would have created. Also important to thinking about data exclusivity is the remarkable speed of inventing around in many biotech-based biologic drug classes and the vigor of crossover competition, which are causing biologics markets to be surprisingly competitive, partly as a byproduct of postapproval research.
In thinking about how long data exclusivity should last, a useful starting point is the exclusivity period typically created by patents. Although patent law provides for twenty years from the time a patent is filed, the research-intensive pathway to FDA approval tends to leave perhaps ten to twelve years of postapproval patent life. That relatively brief period has to generate--at least on average--sufficient revenues and profits to encourage firms to pursue more research in search of molecules, few of which will ever show a profit (DiMasi, Hansen, and Grabowski 2003). The market's strong record in providing broad benefits from postapproval research in competitive therapeutic classes, such as statins, suggests that lengthy research agendas are often extremely beneficial. This in turn suggests that when there is just one drug in an innovative therapeutic class, limits on patent life may suppress valuable research on the class. Although there has been considerable debate over some of the tactics that pharmaceutical firms use near the end of patent life, such as developing variants that are sufficiently attractive to keep some patients from switching to generic versions of the original drug, there seems to be very little evidence that patent-based exclusivity for small-molecule drugs is too long.
Grabowski (2008) reports that in his sample of biologics, development times increased almost linearly from the early 1980s, reaching more than nine years for drugs approved in 2005-2006, leaving less than eleven years of postapproval patent life. That hardly seems excessive, if it were the determining factor in practical marketing exclusivity. There are sound reasons for thinking that modern biologics provide so many benefits from postapproval research extending over many years that exclusivity, whether provided by patents or data exclusivity provisions, should be at least as long as for small-molecule drugs. The fact that some of the same scientific attributes of biologics that generate extended research streams also generate vigorous competition among drugs in a class and across classes suggests that the social losses from providing for fairly long exclusivity periods (twelve to fourteen years) would be small compared to what are likely to be substantial social gains from exclusivity.
The EU is farther along than the United States in dealing with follow-ons and data exclusivity. The EU has already approved several follow-on versions of older and simpler biologics and has constructed a law to govern the approval of follow-ons for newer, more complex biologics. That law provides for ten years of data exclusivity, with an additional year for new indications approved within eight years of initial approval (Grabowski 2008; Woodcock et al. 2007).
Several follow-on biologic bills have been circulated in Congress. S 1695, sponsored by Senators Edward Kennedy (D-Mass.), Mike Enzi (R-Wyo.), Orrin Hatch (R-Utah), and Hillary Clinton (D-N.Y.), would provide twelve years of data exclusivity. S 1505, sponsored by Senator Judd Gregg (R-N.H.), would provide twelve to sixteen years. HR 1956, sponsored by Representative Jay Inslee (D-Wash.) with support from the Biotechnology Industry Organization, a trade group, would provide twelve to fifteen years; HR 5629, sponsored by Representatives Anna Eshoo (D-Calif.) and Joe Barton (R-Tex.), would provide twelve to fourteen years. However, HR 1038, sponsored by Representative Henry Waxman (D-Calif.), would provide no data exclusivity at all.
The Problem of Setting Data Exclusivity Periods. How long should data exclusivity be? For years, economists have debated the analogous question for patents, arriving only at the conclusion that it all depends on many factors and that there is no reason why patent length should be the same for every industry. Nor is there a solid foundation for setting different periods for different industries. For the time being, a unitary system prevails in which the same rules apply to all industries. But data exclusivity is a tool that comes into play when patents fail to provide reasonable protection for innovation. Data exclusivity is arguably more important for modern biologics than for any other industry, and we have to think afresh about exclusivity and how it works in this unusual industry. Given the stakes--a substantial amount of future R&D hangs in the balance--Congress should exercise an abundance of caution in designing follow-on biologic legislation so as not to endanger valuable future research.
One approach to data exclusivity is to examine the record of biologics approved in the past decade or two and estimate how long it took for those products to generate profits after taking account of the time and expense of R&D and the risks of failure (DiMasi and Grabowski 2007). Working with those data and assuming that postapproval research increases financial outlays by 35 percent, Grabowski (2008) estimated payback periods of between 12.9 and 16.2 years depending on the cost of capital (which, in his model, ranged between 11.5 percent and 12.5 percent). Such results might serve as a guide to a suitable period of data exclusivity.
This approach is fraught with peril. Aside from a possibly nonrepresentative sample, the exercise involves numerous assumptions about the cost of capital, profit margins, and prices after the first follow-on enters the market. Reasonable changes to these assumptions can easily affect the results by 30-40 percent (Brill 2008). Another almost insuperable difficulty is how to take reasonable account of the financial risks in biotechnology R&D, in which most products and, indeed, most firms fail before realizing any revenues at all, not to mention profits. Furthermore, one of the most fundamental characteristics of biologics--the dominant role of postapproval R&D--is highly variable and is impossible to predict in terms of either costs or medical value. In particular, because the drugs with the most promising postapproval R&D agendas have reached the market only in the past few years, there is no way to extrapolate from recent experience in order to estimate the future volume, costs, and medical value of postapproval R&D expenditures--although it is already clear that, for many of the most valuable biologics, those expenses will be large relative to initial R&D and will continue for many years.
A Sensible Approach to Data Exclusivity
What makes sense is to rely on a few basic principles and a deep sense of caution about the threat of suppressing R&D. A signal consideration is that if Congress errs by establishing too short a period for data exclusivity, the R&D it suppresses will never be observed, nor will the products that the missing R&D would have created. Also important to thinking about data exclusivity is the remarkable speed of inventing around in many biotech-based biologic drug classes and the vigor of crossover competition, which are causing biologics markets to be surprisingly competitive, partly as a byproduct of postapproval research.
In thinking about how long data exclusivity should last, a useful starting point is the exclusivity period typically created by patents. Although patent law provides for twenty years from the time a patent is filed, the research-intensive pathway to FDA approval tends to leave perhaps ten to twelve years of postapproval patent life. That relatively brief period has to generate--at least on average--sufficient revenues and profits to encourage firms to pursue more research in search of molecules, few of which will ever show a profit (DiMasi, Hansen, and Grabowski 2003). The market's strong record in providing broad benefits from postapproval research in competitive therapeutic classes, such as statins, suggests that lengthy research agendas are often extremely beneficial. This in turn suggests that when there is just one drug in an innovative therapeutic class, limits on patent life may suppress valuable research on the class. Although there has been considerable debate over some of the tactics that pharmaceutical firms use near the end of patent life, such as developing variants that are sufficiently attractive to keep some patients from switching to generic versions of the original drug, there seems to be very little evidence that patent-based exclusivity for small-molecule drugs is too long.
Grabowski (2008) reports that in his sample of biologics, development times increased almost linearly from the early 1980s, reaching more than nine years for drugs approved in 2005-2006, leaving less than eleven years of postapproval patent life. That hardly seems excessive, if it were the determining factor in practical marketing exclusivity. There are sound reasons for thinking that modern biologics provide so many benefits from postapproval research extending over many years that exclusivity, whether provided by patents or data exclusivity provisions, should be at least as long as for small-molecule drugs. The fact that some of the same scientific attributes of biologics that generate extended research streams also generate vigorous competition among drugs in a class and across classes suggests that the social losses from providing for fairly long exclusivity periods (twelve to fourteen years) would be small compared to what are likely to be substantial social gains from exclusivity.
Warner Chilcott Announces Receipt of Paragraph IV Certification Notices
ST. DAVID'S, Bermuda, Dec 08, 2008 /PRNewswire-FirstCall via COMTEX/ -- Warner Chilcott Limited (WCRX:
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WCRX 13.40, +0.04, +0.3%) announced today that one of the Company's subsidiaries and Hospira, Inc. ("Hospira") have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. ("Mutual") and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets.
DORYX, which the Company markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Hospira's subsidiary, Mayne Pharma Limited ("Mayne"), is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.
The Company and Mayne are currently reviewing the detail of the Paragraph IV Certification Notices from Mutual and Mylan and continue to have full confidence in the intellectual property protecting DORYX.
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WCRX 13.40, +0.04, +0.3%) announced today that one of the Company's subsidiaries and Hospira, Inc. ("Hospira") have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. ("Mutual") and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets.
DORYX, which the Company markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Hospira's subsidiary, Mayne Pharma Limited ("Mayne"), is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.
The Company and Mayne are currently reviewing the detail of the Paragraph IV Certification Notices from Mutual and Mylan and continue to have full confidence in the intellectual property protecting DORYX.
Unigene Announces Preliminary Injunction Entered in Patent Infringement Lawsuit to Court Ruling
Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com) announced today that Judge Robert P. Patterson, Jr. of the United States District Court for the Southern District of New York entered a preliminary injunction, consented to by defendants Apotex, Inc. and Apotex Corp., preliminarily enjoining them from engaging in the commercial manufacture, use, marketing, distribution, selling, transportation or importation of any Fortical(R) generic equivalent product in the United States. The preliminary injunction will remain in effect until the court renders a final decision on the validity and infringement of Unigene's U.S. Patent.
In June 2006 Unigene received a Paragraph IV Certification letter from Apotex alleging that Unigene's U.S. Patent No. 6,440,392 is invalid. On July 24, 2006, Unigene and Upsher-Smith Laboratories jointly filed a lawsuit against Apotex for infringement of that patent.
"We are pleased that this action has been taken," said Dr. Ronald S. Levy, Executive Vice President of Unigene. "We will continue to vigorously defend the intellectual property that we have worked so hard to develop."
Standard for a §112 indefiniteness rejection during patent prosecution redefined
Ex parte Miyazaki (BPAI Precedential 2008)
The Board of Patent Appeals and Interferences (BPAI) has re-defined the standard for a §112 indefiniteness rejection during patent prosecution. The BPAI's definition for pre-issuance indefiniteness focuses on 'plausible' indefiniteness and varies dramatically from the Federal Circuit's standard of 'insolubly ambiguous.' The BPAI argues that a lower threshold of ambiguity is justified pre-issuance because it gives the PTO power to ensure that claims are "precise, clear, correct, and unambiguous."
"As such, we employ a lower threshold of ambiguity when reviewing a pending claim for indefiniteness than those used by post-issuance reviewing courts. In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite."The Federal Circuit's insolubly ambiguous standard is premised on the strong presumption of validity associated with an issued patent. The BPAI grounds its lower threshold in the notion that patent applications have no presumption of validity.http://www.uspto.gov/web/offices/dcom/bpai/prec/fd073300.pdf
ACTOS Case-$16.8M Fees Award For Takeda-FC upholds the decision
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the U.S. Court of Appeals for the Federal Circuit affirmed Takeda’s award of attorneys’ fees against generic drug manufacturers, Mylan Inc. and Alphapharm Pty, Ltd., arising out of Takeda’s successful enforcement of its patent covering the active ingredient in ACTOS® (pioglitazone hydrochloride). Mylan Inc. must pay Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. (“TPNA”) $11.4 million plus interest, and Alphapharm Pty, Ltd. must pay $5.4 million plus interest.
Takeda and TPNA sued Mylan and Alphapharm for patent infringement as a result of their filing of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market a generic version of Takeda’s ACTOS®. Mylan and Alphapharm challenged the validity and enforceability of U.S. Patent No. 4,687,777 which covers pioglitazone, the active ingredient in ACTOS®. The U.S. District Court for the Southern District of New York held that the Mylan and Alphapharm challenges to the ‘777 patent were not certified in good faith, as required by the Hatch-Waxman Act. The Court also found that both Mylan and Alphapharm had engaged in litigation misconduct. The Court awarded Takeda it’s the full amount of attorneys' fees claimed against both Mylan and Alphapharm. That decision was affirmed by the U.S. Court of Appeals for the Federal Circuit on December 8, 2008.
Takeda and TPNA sued Mylan and Alphapharm for patent infringement as a result of their filing of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market a generic version of Takeda’s ACTOS®. Mylan and Alphapharm challenged the validity and enforceability of U.S. Patent No. 4,687,777 which covers pioglitazone, the active ingredient in ACTOS®. The U.S. District Court for the Southern District of New York held that the Mylan and Alphapharm challenges to the ‘777 patent were not certified in good faith, as required by the Hatch-Waxman Act. The Court also found that both Mylan and Alphapharm had engaged in litigation misconduct. The Court awarded Takeda it’s the full amount of attorneys' fees claimed against both Mylan and Alphapharm. That decision was affirmed by the U.S. Court of Appeals for the Federal Circuit on December 8, 2008.
Sunday, December 7, 2008
Australia Darunavir Patent Term Extension- Denied
AU Patent number 680635 in the name of G.D.Searle LLC was sealed on 27 November 1997. The normal 20 year term of the patent will expire on 24 August 2013. On 29 August 2007, the patentee filed an application for an extension of term of the patent under section 70 of the Patents Act 1990. The extension is based on the substance darunavir. During examination of the application, a Senior Examiner reported that there was another substance (known as amprenavir) within the scope of the claims that had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG), and as a consequence the application for an extension of term was not made within six months of the commencement of the first inclusion in the ARTG of goods that contain a relevant pharmaceutical substance. The patentee requested a hearing, which was held in Canberra on 15 October 2008. The patentee was represented by Shahnaz Irani, patent attorney with Spruson & Ferguson.
Extension of the term of a patent relating to pharmaceutical substances is governed by Part 3 of Chapter 6 of the Patents Act. For present purposes, the only question relates to when an application for an extension of term must be made. This is addressed in subsection 71(2):
“An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist or, any of the pharmaceutical substances referred to in subsection 70(3);(c) the date of commencement of this section.”In the present case, the date the patent was granted is 27 November 1997, and the date of commencement of section 71 was 27 January 1999 .
The court denied the application for patent extension since the application was not made within six months of the date of the earliest first inclusion in the ARTG. Dr Barker , Delegate of the Commisioner of Patents , further stated that "In a case such as the present, the patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223. Of course, it is also open to the patentee to withdraw the application for extension of term (for instance, if the true term of the extension is zero"
"Equally, the Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made. In the present case the Commissioner has become aware of the listing of amprenavir, and has no option but to act on this information".
Monkelukast suit -Slovenia
Merck Frosst Canada Files Patent Lawsuit against Slovenia’s Krka, Salus
Drug maker Merck Frosst Canada Limited has filed a lawsuit against Slovenian drug maker Krka and drug wholesaler Salus over alleged infringement of patent rights over the ingredient montelukast, seeking 67,917 euro ($87,000) in damages, Krka said on Friday.
Drug maker Merck Frosst Canada Limited has filed a lawsuit against Slovenian drug maker Krka and drug wholesaler Salus over alleged infringement of patent rights over the ingredient montelukast, seeking 67,917 euro ($87,000) in damages, Krka said on Friday.
EU Commission's Antitrust probe
In Jan 2008 EU commission launched a competetition enquiry into the pharma sector. The Commission has the authority to launch sector inquiries when it has indications that competition in the Single Market may be restricted or distorted in a particular sector. The Commission uses this instrument to improve its knowledge about a sector and to identify its main shortcomings, caused by market participants.
The Jan 2008 enquiry was initiated because market information suggested that competition may be restricted or distorted in the pharmaceutical sector. Indicators included a decline in innovation measured by the number of novel medicines reaching the market.
The inquiry looks at competition between originator companies
and generic companies and at competition among originator companies.
A preliminary report by the commission is available here http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html.
The Jan 2008 enquiry was initiated because market information suggested that competition may be restricted or distorted in the pharmaceutical sector. Indicators included a decline in innovation measured by the number of novel medicines reaching the market.
The inquiry looks at competition between originator companies
and generic companies and at competition among originator companies.
A preliminary report by the commission is available here http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html.
The report finds that originator companies have designed and implemented strategies (a
"tool-box" of instruments) aimed at ensuring continued revenue streams for their medicines. Although there may be other reasons for delays to generic entry, the successful
implementation of these strategies may have the effect of delaying or blocking such entry.
The strategies observed include filing for up to 1,300 patents EU-wide in relation to a single
medicine (so-called "patent clusters"), engaging in disputes with generic companies leading
to nearly 700 cases of reported patent litigation, concluding settlement agreements with
generic companies which may delay generic entry and intervening in national procedures
for the approval of generic medicines. The additional costs caused by delays to generic
entry can be very significant for the public health budgets and ultimately the consumer.
"tool-box" of instruments) aimed at ensuring continued revenue streams for their medicines. Although there may be other reasons for delays to generic entry, the successful
implementation of these strategies may have the effect of delaying or blocking such entry.
The strategies observed include filing for up to 1,300 patents EU-wide in relation to a single
medicine (so-called "patent clusters"), engaging in disputes with generic companies leading
to nearly 700 cases of reported patent litigation, concluding settlement agreements with
generic companies which may delay generic entry and intervening in national procedures
for the approval of generic medicines. The additional costs caused by delays to generic
entry can be very significant for the public health budgets and ultimately the consumer.
The sector inquiry confirms that generic entry in many instances occurs later than could be
expected. For a sample of medicines under investigation which had lost exclusivity in 2000
to 2007 the average time to enter after loss of exclusivity was about seven months on a
weighted average basis, whereas also for the most valuable medicines it took about four
months. On average, price levels for medicines in the sample that faced loss of exclusivity
in the period 2000 – 2007 decreased by almost 20% one year after the first generic entry.
However, the decreases in price levels were as high as 80-90% in rare cases for some
medicines in some Member States. Based on the sample of medicines under investigation
that faced loss of exclusivity in the period 2000 – 2007, representing an aggregate postexpiry
expenditure of about € 50 billion over the period (in 17 Member States), the preliminary report estimates that this expenditure would have been about € 14 billion higher without generic entry. However, the savings from generic entry could have been about € 3 billion more, further reducing expenditure for these medicines by more than 5%, if generic entry had taken place without delay. The findings of the inquiry suggest that the practices under investigation contribute to this.
expected. For a sample of medicines under investigation which had lost exclusivity in 2000
to 2007 the average time to enter after loss of exclusivity was about seven months on a
weighted average basis, whereas also for the most valuable medicines it took about four
months. On average, price levels for medicines in the sample that faced loss of exclusivity
in the period 2000 – 2007 decreased by almost 20% one year after the first generic entry.
However, the decreases in price levels were as high as 80-90% in rare cases for some
medicines in some Member States. Based on the sample of medicines under investigation
that faced loss of exclusivity in the period 2000 – 2007, representing an aggregate postexpiry
expenditure of about € 50 billion over the period (in 17 Member States), the preliminary report estimates that this expenditure would have been about € 14 billion higher without generic entry. However, the savings from generic entry could have been about € 3 billion more, further reducing expenditure for these medicines by more than 5%, if generic entry had taken place without delay. The findings of the inquiry suggest that the practices under investigation contribute to this.
The preliminary findings of the inquiry are that in recent years originator companies have
changed their patent strategies. In particular, originator companies confirm that they aim to
develop strategies to extend the breadth and duration of their patent protection. One commonly applied strategy is filing numerous patents for the same medicine (forming so called "patent clusters" or "patent thickets"). Documents gathered in the course of the inquiry confirm that an important objective of this strategy is to delay or block the market entry of generic medicines. A second instrument used by originator companies appears to be filing "divisional patent"applications.
changed their patent strategies. In particular, originator companies confirm that they aim to
develop strategies to extend the breadth and duration of their patent protection. One commonly applied strategy is filing numerous patents for the same medicine (forming so called "patent clusters" or "patent thickets"). Documents gathered in the course of the inquiry confirm that an important objective of this strategy is to delay or block the market entry of generic medicines. A second instrument used by originator companies appears to be filing "divisional patent"applications.
Between 2000 and 2007, originator companies and generic companies entered into a large
number of agreements concerning the sale/distribution of generic medicines. One third of
these agreements concerned originator medicines which still benefited from exclusivity. Further details are available here http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/exec_summary_en.pdf
number of agreements concerning the sale/distribution of generic medicines. One third of
these agreements concerned originator medicines which still benefited from exclusivity. Further details are available here http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/exec_summary_en.pdf
Saturday, December 6, 2008
TRICOR CASE SETTLED
Last week Abbott Laboratories agreed to pay $184 million to settle Antitrust lawsuits for the cholesterol- lowering drug TriCor.TriCor, known chemically as fenofibrate, is used to reduce triglycerides and adjust cholesterol levels. U.S. sales of the drug were $1.22 billion last year, up 16 percent from the previous year.
The drugmakers, buyers and distributors accused Abbott and its business partners of blocking competition by patenting new formulations of TriCor with only minor changes to extend patent protection. The patents allow Abbott to charge higher, brand- name prices for the drug. Abbott generated an additional $5 billion in sales of branded TriCor with the strategy, Robert Van Nest, an attorney for Impax, said during the trial.
The case is In Re TriCor Litigation, 02-1512, U.S. District Court, District of Delaware (Wilmington).
Background of this case:
The drugmakers, buyers and distributors accused Abbott and its business partners of blocking competition by patenting new formulations of TriCor with only minor changes to extend patent protection. The patents allow Abbott to charge higher, brand- name prices for the drug. Abbott generated an additional $5 billion in sales of branded TriCor with the strategy, Robert Van Nest, an attorney for Impax, said during the trial.
The case is In Re TriCor Litigation, 02-1512, U.S. District Court, District of Delaware (Wilmington).
Background of this case:
Fenofibrate is a very old drug. Fournier received FDA approval in 1993 for this drug under the brand name Lipidil, but did not market it.
In 1997 Fournier granted Abbott an exclusive license to US4895726 which claims a formulation of finofibrate.
Abbott introduced the product as a capsule. FDA approved 67 mg capcule on Feb 09, 1998 and 134 mg and 200 mgs capsules on June 30, 1999. Abbott marketed these products ( TRICOR-A) successfully thru 2000 and 2001.
On Dec 14, 1999, Novopharm which was later on acquired by Teva, filed an ANDA for 67 mg capsule and made a Paragraph IV certification that U.S. Pat. No. 4,895,726 was invalid so not infringed . Novopharm later amended to include 134 and 200 mgs capsules also. The claims of the ‘726 patent included among other things , that finofibrate be co-micronized with a solid surfactant in the absence of any excipients.
On May 09, 2000 Impax also filed an ANDA for TRICOR-A similarly seeking to market finofibrate capsules prior to the expiry of the ‘726 patent. Because the ‘726 patent claims require micronization of finofibrate and solid surfactant in the absence of excipients, Teva’s and Impax’s Para IV notifications expressly indicated that they did not use that process.
On or about April 7, 2000, August 18, 2000 and March 19, 2001 respectively Abbott initiated suits in the DC of Illinois against Teva, its subsidiary Novopharm and Impax alleging infringement of the ‘726 pateny under 35 U.S.C 271(e) (2). These suits collectively called as “ Illinois Litigation” imposed a 30 month stay on approval of Teva’s and Impax’s ANDAs.
On March 19, 2002 the Illinois district court granted Teva’s motion for summary judgement of non infringement and the Federal circuit5 subsequently affirmed. While the appeal was pending Teva obtained approval for 67, 134 and 200 mgs capsules on April 9, 2002. Teva’s 134 mg and 200 mg capsules also entered the market thereafter.
During the pendency of the capsule “ Illinois litigation” , Abbott started to develop tablet formulation of TRICOR in 54 mg and 160 mgs strengths ( TRICOR-B) Abbott filed a new NDA for 54 mg and 160 mg TriCor in a tablet formulation arguing that the tablet was bioequivalent to the capsule. On September 4, 2001 Abbott obtained FDA approval for TRICOR –B. Abbott stressed that TRICOR B had an additionl indication for HDL effect while TRICOR A had not been approved for the HDL treatment.( however in the antitrust suit the direct purchaser plaintiffs are arguing that TRICOR B did not provide the public with better or improved product because it contained the same drug as the earlier approved capsules and was therapeutically equivalent and bioequivalent to the capsules)
Abbott stopped selling the capsules and bought back all the capsules from the market, directed all their forces to sell only TRICOR B.On or about Dec 2001 Abbott also caused TRICOR A to be listed as obsolete in the National Drug Data File. This Obsolete listing caused Teva’s corresponding generic version of TRICOR –A to be identified as a brand drug and consequently resulted in a higher co-payment for Teva’s generic product. (The NDDF is a private database that provides information about FDA-approved drugs. Changing the code to obsolete then removed the TriCor capsule drug formulation from the NDDF, which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation)
As a single source drug in the NDDF, Teva’s finofibrate capsules generally were not afforded the preffered formulary status given to generic drugs. Some insurers did not add Teva’s generic capsules to their drug formularies and refused to pay for them at all.
On or about June 17, 2002, Teva filed an ANDA for 54 mg and 160 mg tablets along with a Para IV certification that its tablets did not infringe the ‘726 patent and also a para IV certification of non infringement against 2 more patents US6074670 and US6277405 listed against TRICOR-B. Teva amended its ANDA on July 29, 2003 and December 17, 2003 respectively by filing additional paragraphs one for US6589552 and one of US6652881.
In 3 separate complaints filed in the DC of Delaware Abbott alleged that Teva infringed the 5 patents to which Teva had filed Para IV certifications. The first and the second complaints imposed 2 successive 30 month stays thus delaying the approval of Teva’s tablet ANDA. The first 30 month stay triggered expired on Feb 26, 2005 and second on Feb 2006.Impax filed its ANDA to tablets on Dec 2002. Summarily Impax submitted para IV certifications that they did not infringe ‘726, ‘670 and ‘405 patents. On Jan 23, 2003 Abbott sued Impax resulting in another 30 month stay. The Issuance and orange book listing of the ‘552 patent resulted in an additional infringement case against Impax as well as a 30 month stay.
On March 5, 2004 FDA granted tentative approvals to Impax’s and Teva’s Tablet ANDAs. Absent the 30 month stays in effect, Impax and Teva would have received final approval by March 5, 2004.
Teva and Impax litigations were then consolidated ( “ The Delaware Litigation”). Trial was scheduled for Dec 6, 2004 but was pushed back to June 6, 2005 to allow filing of the infringement action related to the ‘552 patent. A month before the trial Abbott dropped its claims voluntarily
During the pendency of the “Delaware Litigation” Abbott implemented a second switch in late 2004, eight months after the generic manufacturers received tentative approval from FDA for tablet ANDAs. Abbott developed new dose TRICOR-C during the delay in generic entry caused by first conversion and the Delaware litigation. The FDA approved Abbott’s NDA for TRICOR –C in 48 mg and 145 mgs on November 5, 2004. TRICOR-C includes the same ingredients and is indicated for the same use as TRICOR-B. However the new dosage strengths of TRICOR-C precluded generic substitution of those approved for TRICOR-B. TRICOR C allowed patients the convenience of taking TRICOR with meals ( Dissolvable form) The dissolvable version of TriCor retains patent protection until 2018.
Abbott sued, again triggering the 30-month stay during which it changed the dose, nullifying, once again, Teva’s generic. Abbott is no longer marketing the 54 mg and 160 mg strength tablets because it has now changed its Tricor product to 48 mg and 145 mg strength tablets. Abbott even filed a new NDA for 48 mg and 145 mg TriCor tablets looking to change the label to state that the new tablets do not need to be taken with food (the dissolvable version). The dissolvable version of TriCor retains patent protection until 2018.
In June 2005, both Teva and Impax announced they had settled TriCor patent litigation with Abbott and Fournier. However, both companies then pressed antitrust claims against Abbott and Fournier, alleging that the companies' actions through two market conversions and the gaming of the Hatch-Waxman Act through sham patent litigation frustrated generic competition in fenofibrate products. In addition, groups of direct and indirect purchasers separately sued Abbott and Fournier for similar violations of the Sherman Act.
Teva enlisted 25 state attorneys general (the states involved are Arizona, Arkansas, California, Connecticut, the District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, Nevada, New York, Oregon, Pennsylvania, South Carolina, Washington, and West Virginia.) to file a suit in federal court in Delaware alleging that Abbott has illegally used “product switching” to avoid generic competition.
As of July 2008, twenty-five states and the District of Columbia have filed antitrust suits1 against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier in Delaware District Court, charging them with blocking generic competition by engaging in product hopping, among other “anti-generic strategies. According to the AGs in the states, the companies made trivial changes to the formulations of TriCor, and marketed those while withdrawing the original drug from the market. The companies deleted references to the original forms of the drug from national drug databases, according to prosecutors, making it more difficult for a generic version of TriCor to obtain generic status.The states filed their lawsuit in federal court in Wilmington, Delaware, accusing Abbott and of undermining efforts to bring generic drugs to market by patenting new formulations of TriCor with only minor changes to the drug.
TriCor, which costs more than $3 a pill, generated sales of $1.2 billion for Abbott in 2007, but the company, according to the lawsuit, has tried to maintain a monopoly on the market by obtaining term-extending patents. Abbott denies the allegations saying it has not prevented other fenofibrate drugs from being marketed.The prosecutors say Fournier obtained patents covering the variations of TriCor and then filed patent infringement lawsuits against generic companies that tried to compete. The litigation meant that the Food and Drug Administration could not approve generic versions of TriCor.In her Sept. 24 opinion, Judge Sue L. Robinson of the U.S. District Court for the District of Delaware said a jury could reasonably find patent infringement claims made by the defendants( ABBOTT) in their separate infringement litigation over generic versions of TriCor capsules and TriCor tablets to be objectively baseless. The judge thus denied the defendants ABBOTT’s motion to dismiss the plaintiffs' sham litigation claims related to infringement. However, the judge granted the defendant ABBOTT’s summary judgment motion with respect to the plaintiffs' Walker Process claim and sham litigation claim based on inequitable conduct. The plaintiffs, Robinson said, failed to produce the requisite clear and convincing evidence of inequitable conduct, and failed to show that test data the defendants supplied to the Patent and Trademark Office was objectively false.
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