Sandoz gains backing for Enbrel patent term review
Sandoz, a subsidiary of Swiss pharmaceutical company Novartis, has gathered support for its request for an en banc rehearing of a ruling that blocks it from selling a version of biologic Enbrel (etanercept) until 2029.
In July, a decision handed down by the US Court of Appeals for the Federal Circuit upheld Amgen’s two patents, preventing Sandoz from selling a version of its rheumatoid arthritis drug.
Sandoz requested an en banc rehearing of the decision on July 31, in which it argued that that the ruling meant that Amgen, which “has already enjoyed a full patent term” on the drug would experience “an unpreceded 31 years” of patent exclusivity.
The filing added that the decision had “created an opening for patentees to extend their exclusivity far beyond one legitimate patent term” and that it would “block competition long past the time when that invention should belong to the public, will harm consumers and cost the health-care system billions of dollars”.
On August 14, the Association for Accessible Medicines, which represents generic and biosimilar makers, and America’s Health Insurance Plans, which represents insurers, filed an amicus brief in support of Sandoz’s request.
In the amicus, they wrote that: “when patent monopolies exist, patients suffer,” and that extending Amgen’s patent term meant “that biosimilar manufacturers must wait another decade” to produce lower cost alternatives to Amgen’s “pricey product”. Pharmaceutical company Samsung Bioepis also filed an amicus brief in support of the request.
In 2016, Amgen accused Sandoz of infringing two patents, US numbers 8,063,182 and 8,163,522, after the company filed an application for Erelzi, a biosimilar version of Enbrel.
Biologics developer Immunex first licensed the patents from Roche more than 30 years ago. After Amgen acquired Immunex in 2002, it entered into an “accord and satisfaction” agreement with Roche, which gave Amgen the exclusive right to prosecute the patents, as well as the first right to sue for infringement and retain any damages.
The US District Court for the District of New Jersey ruled in favour of Amgen after it held that Sandoz could not prove that the patents were invalid. Sandoz then appealed the court’s decision to the Federal Circuit, which upheld the infringement finding by a majority of 2-1.
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