By James DeGiulio --
Medicis and Nycomed Settle Vanos Patent Dispute
Medicis and Nycomed have reached a licensing agreement to settle a patent dispute over a generic version of the psoriasis treatment Vanos. In May 2010, Medicis filed the suit in the Southern District of New York in response to Nycomed's ANDA seeking approval from the FDA to make and sell 0.1% fluocinonide cream before the expiration of Medicis' U.S. Patent Nos. 6,765,001, 7,220,424, and 7,217,422 (see "Court Report," May 23, 2010). Nycomed's ANDA included a Paragraph IV certification asserting that the three patents would not be infringed by its generic version of Vanos. According to the complaint, Nycomed was required to amend its ANDA to provide certification relating to U.S. Patent No. 7,794,738, at issue in another Medicis-Nycomed dispute, but Medicis had yet to receive notification of any such amendment.
On August 16, U.S. District Judge Denise L. Cote signed off on a stipulation and order of dismissal dismissing the suit with prejudice after the two parties notified the Court that they had agreed on a licensing agreement. Nycomed admitted that Medicis' patents covering Vanos were valid and enforceable, and that its ANDA for a generic version of Vanos would infringe Medicis' patents outside of the licensing agreement. The Court noted the public interest in judicial economy in dismissing the suit, and both parties waived any right to appeal the stipulated order. Medicis will grant Nycomed a license to make and sell generic versions of Vanos products beginning December 15, 2013. In return, Nycomed will pay Medicis a royalty based on product sales.
Pfizer Successfully Defends Viagra Patent Against Teva
Pfizer has prevailed in its patent infringement action against Teva over a generic version of Viagra, securing a ruling that the Pfizer patent for the blockbuster drug remains valid and enforceable. On March 24, 2010, Pfizer sued Teva in U.S. District Court for the Eastern District of Virginia, challenging the generic drug maker's contention that U.S. Patent No. 6,469,012 is invalid or would not be infringed by Teva's proposed generic (see "Court Report," April 4, 2010). The '012 patent represents an important holding for Pfizer, as it does not expire until 2019. During a 12-day bench trial in July, Teva conceded that its proposed generic drug would infringe the '012 patent. However, Teva raised a series of challenges to Pfizer's patent, including the validity and enforceability of the patent, as well as Pfizer's standing to sue.
On August 15, U.S. District Judge Rebecca Beach Smith, in a lengthy opinion, found that the decision to try an orally administered version of the active ingredient, sildenafil, to treat erectile dysfunction was not obvious. Judge Smith distinguished the standard of "obvious to try" with a mere "motivation to try." She also ruled against Teva with respect to its claim of double patenting, finding the compound to be sufficiently different from a similar version protected by an earlier Pfizer patent, noting that even small changes in chemical structure could significantly affect how the drug worked in the body.
In a significant portion of the opinion, Judge Smith cited Therasense and chastised Teva for wasting judicial resources by trying to have the patent declared unenforceable by accusing Pfizer and one of its attorneys of engaging in inequitable conduct by not submitting information related to the Canadian version of the patent during prosecution. Judge Smith found that the material was not relevant to the prosecution of the U.S. patent because the patent examiner had already asked the company not to submit further foreign references similar to what had already been provided. Teva also lost a bid to amend its answer to flesh out inequitable conduct claims against the company and some of its attorneys. Judge Smith ruled that not only did Teva unnecessarily delay in seeking to amend its counterclaims, but that Pfizer and the accused individuals would be prejudiced by such a late change.
The Court's decision prevents Teva from receiving approval for a generic form of Viagra until October 2019. Litigation on the same patent remains pending against other generic companies, but no trials have been scheduled in those other cases.
Lilly and Hospira Settle Gemzar Patent Suit
Eli Lilly and Hospira have reached a settlement dismissing Hospira's declaratory judgment action over the patent covering the ovarian, breast, lung, and pancreatic cancer treatment Gemzar. On September 30, 2010, Hospira filed suit against Lilly in the Northern District of Illinois, seeking a declaratory judgment that its plans to sell several versions of a generic version of Gemzar, also known as gemcitabine, would not infringe Lilly's U.S. Patent No. 5,606,048, which protects a "stereoselective glycosylation process for preparing" the drug (see "Court Report," October 3, 2010). Hospira filed an ANDA seeking regulatory approval to sell three versions of the drug in late 2009, and was making preparations to sell the product immediately upon approval. Hospira asserted non-infringement of the '048 patent, but claimed reasonable apprehension that Lilly would assert the '048 patent against Hospira to block the marketing and sale of Hospira's competing product. Hospira contends that Lilly's foreign lawsuits over the drug in Denmark and the United Kingdom gave it a reasonable apprehension that Lilly intended to file a lawsuit to block a generic drug release in the U.S.
On August 10, U.S. District Judge Milton I. Shadur affirmed the parties' stipulation regarding dismissal with prejudice. The settlement brings to an end the U.S. litigation over Gemzar, which has arisen between the two parties in five different countries. Each side is to bear its own costs and attorneys' fees. Additional terms of the settlement were not immediately available.
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