By James DeGiulio --
Watson Invalidates Cephalon's Fentora Patents
Watson Pharmaceuticals won a substantial victory in its lawsuit with Cephalon over Fentora when the generic drugmaker successfully established that two of three asserted patents covering the drug are invalid. The dispute between the parties began in June 2008, when Cephalon filed suit against Watson in the U.S. District Court for the District of Delaware over Watson's ANDA filing covering a generic version of Fentora (see "Court Report," June 8, 2008). Cephalon alleged infringement of U.S. Patent Nos. 6,200,604 and 6,974,590. In September 2009, Cephalon brought another suit against Watson, alleging that Watson also infringed U.S. Patent Number 6,264,981 (see "Court Report," October 4, 2009). Cephalon has also brought suit against Mylan and Barr, and has reached a settlement with Barr granting Barr a nonexclusive, royalty-free license to market and sell a generic version of Fentora in the U.S. as of October 2018.
In an opinion issued on March 11, Judge Sue L. Robinson determined that Cephalon had failed to prove that Watson infringed the asserted claims of the '604 and '590 patents and that Watson had successfully proven the asserted claims to be invalid for lack of enablement. In the first section of her opinion, Judge Robinson adopted Watson's proposed claim constructions for the '604 and '590 patents. Turning to the issue of infringement, the Judge Robinson found that Cephalon had failed to show that a reaction in Watson's product produced an effect that was required to establish infringement. Judge Robinson also held that bioequivalence was insufficient to establish infringement under the doctrine of equivalents. Finally, in addressing Watson's invalidity counterclaims, Judge Robinson was persuaded by Watson's expert who indicated that a person of ordinary skill in the art would not be able to practice the invention of the two patents without undue experimentation. The opinion and accompanying order did not issue a ruling on the '981 patent.
Sanofi Agrees to Judgment Barring Assertion of Taxotere Patents
After a ruling in a related case rendered Sanofi-Aventis' patents covering Taxotere invalid for obviousness and inequitable conduct, the company agreed to a judgment preventing it from asserting these patents against Sandoz. In January 2011, Sanofi filed suit against Sandoz in the U.S. District Court for the District of Delaware, accusing Sandoz of infringing U.S. Patent Nos. 5,750,561 and 5,714,512 (see "Court Report," January 16, 2011), despite a previous ruling in a related case with Hospira and Apotex that found these two patents invalid (see "Biotech/Pharma Docket," September 30, 2010). The suit against Sandoz was based on its NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) covering a docetaxel injection product. Sanofi also has a suit pending with Accord Healthcare over its NDA and Paragraph IV certification. Sanofi has appealed the invalidity ruling from the Hospira and Apotex case.
On March 11, Judge Gregory M. Sleet signed off on a consent order and judgment, which the parties signed to promote efficiency and economy for themselves and the District Court. The judgment bars Sanofi from asserting the two patents until a decision from the Federal Circuit is issued in the related case. Plaintiffs reserved all rights to appeal from this final judgment. The future of the case depends on the action of the Federal Circuit in the related case. If the Federal Circuit affirms the invalidity ruling in the Hospira and Apotex case, Sanofi waives its righ to appeal or seek modification of the current judgment. However, if the Federal Circuit vacates or reverses the invalidity ruling, the plaintiffs could reinstate their infringement claims as to the two patents.
Teva Dismisses Mylan's Inequitable Conduct Defenses in Azilect Dispute
Mylan will have to press on without an inequitable conduct defense in its dispute with Teva over the Parkinson's drug Azilect, after Teva successfully moved to dismiss Mylan's defense. Last October, Teva filed suit in U.S. District Court for the District of New Jersey, alleging that Mylan (and other generic makers) infringed U.S. Patent No. 5,453,446 by submitting ANDAs for generic Azilect (see "Court Report," October 10, 2010). Mylan raised its inequitable conduct defense in a November 30 response to the complaint, alleging that the '466 patent was unenforceable because the applicants did not disclose to the examiner that both deprenyl and PAI are R-enantiomers. Mylan alleged that by failing to disclose this information, Teva, which asserted that the invention was "surprising and unexpected," intentionally misled the patent examiner.
In an opinion issued on February 24, Judge Jose L. Linares granted Teva's motion to dismiss Mylan's counterclaims and affirmative defense alleging inequitable conduct. Judge Linares found that Mylan had failed to plead the circumstances of inequitable conduct with the requisite particularity under Rule 9(b), which requires that a plaintiff make sufficient allegations of underlying facts from which a court can reasonably infer the requisite intent to deceive the USPTO. Judge Linares, following Exergen Corp. v. Wal-Mart Stores, Inc., found that Mylan had not sufficiently identified the individuals involved or why the information withheld or misrepresented was material. Judge Linares also granted Mylan an opportunity to amend its complaint to remedy the shortcomings of its pleadings.
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