NOVO NORDISK LOSES APPEAL ON PATENT SUIT
Novo Nordisk Pharmaceuticals has lost a challenge in the U.S. Court of Appeals
for the Federal Circuit to overturn a lower court ruling that part of Novo's
patent on its human growth hormone (HGH) Norditropin (somatropin recombinant)
was invalid and unenforceable due to inequitable conduct. While Novo has partially
settled its lawsuit with defendants Savient and Teva Pharmaceutical, the decision
keeps the door open to generic versions of Novo's product.
In August 2004, the U.S. District Court for the District of Delaware ruled against Novo in its patent suit against Bio-Technology General now Savient and Teva, Bio-Technology's licensing partner for its HGH product Tev-Tropin. In February 2005, however, Novo, Savient and Teva entered into a settlement agreement, granting each other cross-licenses to any patents covering the HGH active ingredient. That month, Savient and Teva also launched their contested product, Tev-Tropin, and dropped their claims for attorneys' fees and damages for wrongful injunction. The appeals court ruling relates to that part of the court dispute that was not part of the settlement, which involves determing who owns the patents.
The Federal Circuit upheld the first part of the district court ruling, which stated that one of Novo's patent claims was invalid because the information necessary to make HGH had been published in an earlier article. It also agreed that the patent claim was unenforceable because Novo was not able to create HGH by the process it described in its patent. The appeals court, however, vacated the lower court's ruling of invalidity for the second claim in the patent.
The first claim was invalid, the district court said, because the methodology and materials for creating synthetic HGH had already been described or "anticipated" in a December 1981 article by George Pavlakis, published in the journal Biochemistry.
The Federal Circuit agreed that the 1981 Pavlakis article "clearly and convincingly discloses all of the limitations of claim 1 of the '352 patent," the court said.
The appeals court also agreed that Novo's '352 patent was invalid because of inequitable conduct. Novo failed to disclose that it had never actually created HGH by the process described in the 1983 application, on which its patent was supposedly based. The lower court also ruled that the 1983 patent was not enabled because it was not possible to produce HGH using the information in the 1983 application.
Novo's '352 patent was based on its '856 application, which was supposedly based on its earlier 1983 application. However, the '856 and 1983 applications name two different processes to produce HGH, one using LAP enzyme and one using DAP I enzyme. Only the process described in the later '856 application, using DAP I enzyme, was actually able to produce "ripe HGH protein." Novo acknowledged that its scientists were not able to actually create HGH for five months after they submitted their 1983 application, until they accidentally used a batch of LAP that was contaminated with DAP I.