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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