Friday, March 13, 2009

DRL wins Omeprazole Mg OTC summary judgement

· ‘424 and ‘960 patents cover the OTC product and claim highly crystalline form of Omeprazole Magnesium( atleast 70%) and a unique water based process for making the same.
· If any party develops a product that does not reach 70% crystallinity then it would not infringe. DRL developed a different form, amorphous with less than 1% detectable crystallinity using a different manufacturing process that is alcohol based.
· Infringement requires proof that each and every element of the claim is present in the alleged infringing product. DRL contended that it did not meet atleast one limitation of the claim namely 70% crystallinity. Astrazeneca requested for samples from DRL and carried out its own testing. Astrazeneca further submitted to the court that the DRL capsules were tested and were not found to be infringing. However Astra contended that DRL might be using a crystalline material to make the amorphous product and might be adding water at some step.
· Instead of getting into a full fledged discovery the parties finished briefing this motion instead for a summary judgement. Astrazeneca was persisting on the argument that any batch of omeprazole salt containing water would somehow infringe the patent- even if additional quantities of water were not added deliberately to the salt during the manufacturing process but rather absorbed into the mixture by surrounding air. Astra hence essentially argues that “ by the addition of water” should be read as “ in the presence of water”( sufficient to facilitate crystallization). Any process that “adds water” relative to the amount of other solvents to facilitate crystallization will infringe the claims. DRL doesn’t agree, the plain meaning of “ adding water” means “ deliberately putting water”. Further during prosecution Astra amended all the claims to include “ by addition of water” limitation. A notice of allowance to Astra patents was finally issued because “ the process claims are patentable because of step of adding water to crystallize the claimed product”
· Give the above facts district court concluded that " under supreme court precedent Astrazeneca's amendment of the crystallization step to include " by the addition of water" after the repeated rejection of claims that did not have that limitation, absolutely prohibits it from obtaining a construction that cover what it gave up See Smith v Magic City Kennel Club Inc, 282. U.S 784, 790, 1931." Further the court stated that "the phrase " by the addition of water" as used thruout the '424 patent- in every claim in which it appears-means that a quantity of water that was not present during steps 1 and 2 of the 4 step process must be deliberatelty and affirmatively placed into the mixture during step 3 ( the crystallization step) which takes place following the separation of organic salts from the reaction mixture. I agree with defendents that there is no basis in the intrinsic evidence to suggest Astrazeneca's construction that the crystallization need only be " facilitated" by water that happened to be present , rather than being deliberatly put into the process"

· With respect to literal infringement of product claims , court ruled that DRL clearly does not infringe, but as DRL points out "a competitor wishing to introduce a lower cost competing product would be likely to design the product around the patent, even if the patented product is in some respects clinically superior. And since the principle and central claim of the patents in suit is highly crystalline omeprazole magnesium , the logical step for a competitor who wishes to use omeprazole in its antacid is to use a salt that is not highly crystalline ! Astrazeneca may well be right that Prilosec OTC is superior to DRL's, but the battle will be fought in the marketplace, it is for consumers to decide whether they can get sufficient relief - gastric and otherwise- using DRL's "inferior" but less expensive product"

· Under doctrine of equivalents court ruled that "Because Astrazeneca argued to the USPTO that its patented product could be distinguished from other products because it was more than 70% crystalline, it cannot now argue that a product less than 70% crystalline infringed and doctrine of equivalence. Springs Window fashion LP V. Novo Indus L.P 323 F.3d, 989, 995, ( Fed Cir 2003)

· With respect to process claims, Astra alleged that somewhere in the manufacturing step DRL might be making the patented crystalline product, and must do so by addition of water. Court found that DRL at no stage is using the claimed process and product. Further it is irrelevant whether DRL ‘s process at some stage uses the patented form as long as its absent in the final product( 271(g))

CAFC- March 12, 2009-Herbal patent claims held anticipated under 102(b)

The patent at issue claimed a composition which promotes weight loss using a combination of herbs(Guarana, Damiana and Paraguay), wherein one herb is capable of inhibiting gastric emptying and another herb is capable of increasing metabolic rate.

Federal circuits affirmed that this claim was anticipated by Medi-tab capsules whose clinical testing reports were submitted to Danish authorities one year prior to the priority date of the patent at issue. Medi-Tab capsules contain three herbal extracts: Guarana, Damiana and (Yerbe) Maté, which is another term for the herb Paraguay.

In determining that the patent was anticipated by the Meditab data, CAFC relied on declaration of Scherer, director of Scientific-Ethical Committee of Copenhagen in Denmark where the Medi-tab capsule registration was carried out. To rebut this evidence defendents has submitted declaration from a Sanders a Danish attorney who stated that “Since the formulation for the Slimming Product disclosed in the [Medi-Tab] Application would be regarded as “information on technical plan or processes or on operation or business procedures or the like, the [Medi-Tab] Application is covered by the exception in article 12(1), 2° of The Danish Open File Act, and would not have been available to the public before the effective filing date of [the] U.S. Patent Application”

CAFC concluded that Sanders’ declaration failed to establish that the Medi-Tab Application would have qualified for exemption from disclosure under Article 12(1) of the Danish Open Files Act. In order to be exempt from disclosure under that provision, information must be of such “material importance to the economy of the person or enterprise” that a request for access to the information will be refused. Sanders, however, failed to demonstrate that the information in the Medi-Tab Application was of “material importance” to Remedies’ “economy.”
CAFC observed that the Medi-Tab Application stated that the results of the Medi-Tab study would be “published in an international gastro-enterological medical publication,” and that this undercut Remedies’ assertion that information in the application was intended to be kept confidential.
As per 102- “A person shall be entitled to a patent unless . . . the invention was patented or described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for patent in the United States.” This statutory “bar is grounded on the principle that once an invention is in the public domain, it is no longer patentable by anyone.”

Both parties agreed that Medi-Tabs teach each and every element of the claim. They also agree that it was submitted to Danish authorities more than year before the priority date. The issue here was whether the Medi-Tab Application was accessible to the public and therefore a “printed publication” under 35 U.S.C. § 102(b).
Scherer stated, based upon her “personal knowledge” that the Medi-Tab Application was a “public record” that had “been open to inspection by the public” since April 10, 1996 “in accordance with the rules in the Danish Open Files Act.” The board’s determination as to public accessibility, moreover, is supported by the fact that the Medi-Tab Application itself contains no restrictions on public dissemination. To the contrary, the application states the results of the study would be “published in an international gastro-enterological medical publication.” Furthermore, the application indicates that volunteers participating in the study will be provided with the project number of the clinical trial notification—presumably so that they could access information about the study in the Copenhagen Committee’s index. The fact that there is nothing in the Medi-Tab Application evidencing an intent to keep its contents confidential serves to buttress the board’s determination that it was publically available prior to the ’107 patent’s critical date

Wednesday, March 4, 2009

EU, States Clash Over Generic Drug Swoop

Azevedo said Brazil did not rule out launching a formal trade dispute at the WTO over the Losartan case.
The European Union and developing countries clashed on Tuesday over the treatment of generic drugs, with Brazil accusing Brussels of trying to undermine special public health rules for poor countries.
But the European Union said it had the right to inspect generic drugs in transit, to protect EU citizens and people in developing countries from the risk of fake medicine.
The argument involved the detention last December by Dutch customs authorities of an Indian generic drug to treat high blood pressure while in transit in the Netherlands for Brazil.
It touches on one of the most sensitive issues between rich and poor countries -- access to affordable medicine -- and has been cited by developing countries as an example of rising protectionism in the economic crisis.
Brazil's envoy to the World Trade Organisation told a WTO meeting on the trade in intellectual property agreement TRIPS that the Dutch move was part of a pattern by rich countries to try and claw back special treatment for poor countries.
"Not only is this a violation of the WTO disciplines but it runs counter to the spirit of everything developing countries negotiated under TRIPS to get the flexibilities that would allow public health concerns of developing countries to be taken into consideration, to be protected," Roberto Azevedo told reporters after the meeting.
Azevedo, whose arguments were echoed by India and backed by another dozen developing countries, said the detained cargo of 570 kilos of Losartan Potassium, an ingredient used to make an arterial hypertension drug, had been enough to treat 300,000 Brazilian patients for one month.
The drugs were held to investigate an alleged violation of IP rights, not to safeguard health in poor countries, he said.
He said there were similar examples, and Brazil was now investigating more than a dozen seizures of drugs in the Netherlands in 2008 intended for seven Latin American and African countries.
FORMAL TRADE DISPUTE
Azevedo said Brazil did not rule out launching a formal trade dispute at the WTO over the Losartan case.
But the head of the EU delegation to the TRIPS meeting, Luc Devigne, said there was no legal basis for a dispute, and added that Brazil had not raised any of the other cases with Brussels.
"We remain fully committed to a policy of access for medicine," he told reporters, noting that Europe was one of the world's biggest producers of generic drugs in any case.
But he said the TRIPS agreement allowed WTO members to inspect goods in transit, including generic medicines.
Fake medicine in the EU rose by half between 2006 and 2007, with one third coming from India, and a two-month action in late 2008, known as MEDI-FAKE, resulted in the seizure of 34 million illegal medicines, he said.
"Many countries actually should be grateful to European customs who most likely have saved lives and certainly in developing countries, because fake medicines are more spread in developing countries than developed countries," he said.
In this case Dutch customs held the cargo at the request of a company holding Dutch patent rights, he said.
After a settlement between the patent-holder and the exporter, India's Dr Reddys Laboratories Ltd, customs returned them to Dr Reddys, who flew them back to India rather than continuing the shipment to Brazil, he said, adding that 21 companies in Brazil also manufactured the drug.
Devigne declined to name the patent-holder, but trade officials said it was U.S. company Merck & Co , under the name Merck Sharp & Dohme. Losartan is the generic name for the drug Cozaar developed jointly by Merck and E I du Pont de Nemours & Co (Dupont).

Pfizer Aurobindo Deal

PFIZER has entered into a series of agreements with Aurobindo Pharma to market medicines that are no longer patent protected and don’t have market exclusivity in the US and Europe. Pfizer will take on licence, an array of generic pills and injectible medicines, as it looks to off-patent medicines for the growth, said a senior executive on Tuesday, adding that it is focusing on such off-patent medicines to increase profits.
The company estimates that the deal with Aurobindo would boost its revenue by $200 million till 2014. "Aurobindo will manufacture the products and we will be responsible for the marketing," said Pfizer senior vice-president Kevin Cooper. "Currently, this is for the US and Europe market but we are also in talks for other geographies as well." Pfizer’s established products business unit was launched in 2008, as part of the company’s initiative to create smaller, more accountable business units aligned with customer needs. It is part of its generics subsidiary Greenstone, which currently has 300 products in its basket, including former blockbusters such as Zoloft for depression, Norvasc for high blood pressure, Zithromax for bacterial infections and Medrol for inflammatory and immune conditions such as asthma, arthritis and lupus. Pfizer’s deal with Aurobindo is its first in-licensing deal where the US-based pharma giant takes on licence, products from Aurobindo. "We consciously chose to in-licence generic products that we did not develop in-house. We looked at Aurobindo’s manufacturing facilities and are happy with them," said Mr Cooper. ink marketing deal

Inspire chose not to sue generic applicants on eletriptan ANDA because of the losses incurred

Fourth quarter losses were narrower at Inspire Pharmaceuticals than analysts had expected thanks to strong sales of the company's drugs.
But the company, which remains unprofitable, says it will cut about 20 research positions as it seeks to preserve cash and focus on its most developed experimental treatments.
"Given the current economic and capital-raising environment, we are prioritizing and focusing resources on our late-stage clinical programs and revenue-generating marketed products," CEO Christy Shaffer said in a written statement.
Durham-based Inspire (Nasdaq: ISPH) says it lost $9.7 million, or 17 cents per diluted share, in the quarter ended Dec. 31, 2008. A year earlier, the company lost $18.1 million, or 51 cents per diluted share.
Revenue increased by 35 percent, to $18.9 million, from $13.9 million.
Inspire said strong sales of AzaSite, a pink eye medicine it launched in 2007, helped it grow sales. The company also saw increased revenue from Restasis, a dry eye treatment.
Analysts polled by Thomson Reuters had, on average, expected Inspire to post a fourth quarter loss of 24 cents per share on revenue of $17.8 million.
"During 2008, we delivered on both our financial goals and key clinical milestones," Shaffer said.
But Inspire remains unprofitable, and the company is burning through cash. Inspire had $73 million worth of cash and equivalents on its balance sheet as of Dec. 31. A year earlier, that figure was $140 million.
And tough financial markets are making it hard for companies to raise cash, leading some to turn, like Inspire, to job cuts.
For 2009, the company says, it expects revenue in the range of $80 million to $90 million. Analysts project sales of $83.9 million.
Beyond 2009, the company's revenue streams are less certain. Inspire said in February that the holder of the patent on an Inspire drug, Elestat, has decided not to challenge generic drugmakers who want to sell copies of the treatment. Such generics could, potentially, hit the street in 2010 and wipe out nearly all of Inspire's revenue from Elestat.
Possible streams of new revenue include two drugs that are in late-stage trials: the cystic fibrosis treatment denufosol and the dry eye drug Prolacria.
Inspire said Tuesday that it expects its cash to last it through 2009 and into 2010.