Any biosimilar manufacturer will tell you that one of the most daunting and delaying issues in biosimilar development is the abuse of the patent system by reference manufacturers. They delay launch by years, resulting in billions in additional revenues for the reference product, and extra workload for the courts.
At last week’s GRx+Biosims meeting, panelists discussed the current state of the patent system facing biosimilar makers today, and prospects for addressing these hurdles to commercialization.
Robert Cerwinski, JD, Managing Partner, Gemini Law, said that although inter partes review (IPR) is generally an inexpensive route for patent disputes (relative to district court cases), the latest US Patent and Trademark Office notice of rulemaking “will effective remove IPR as an option for generic and biosimilar companies.” Public comments on this rule are due November 17.
Sara Koblitz, JD, Director, Hyman, Phelps & McNamara explained that the US allows patent thickets to develop, to the extent that against the same 30 biosimilars worldwide, the reference manufacturers has asserted some 377 patents in the US vs only 46 in Canada and 24 in the UK. “A patent owner in the US may obtain multiple patents with nonpatentably distinct claims. Double patenting is generally prohibited by patent offices around the world, but not in the US,” she said. The USPTO, however, will permit patent owners to meet an “obviousness-type double patenting” challenge by filing a “terminal disclaimer,” which aligns the expiry date of the multiple patents. “This is supposed to ensure that patents claiming the same invention could not inappropriately extend the life of the original, or ‘parent patent.’ Instead, this results in a cluster of patents, and maximum complexity and launch delays,” said Ms. Koblitz.
She provided a case example where 73 patents were claimed based on 14 distinct inventions, but of which 59 patents were non-patently distinct. In this case, 10 patents were created just for the product composition, 7 patents for the primary indications, 18 patents for secondary indications, 21 patents for the initial formulation, and 4 more for the follow-on indication. In Europe, only 8 patents are granted (2 for the product composition, 2 for primary indications, 1 for the secondary indication, 2 for formulation, and none for the follow-on indication).
Biologic manufacturers tend to add patents with terminal disclaimers just as the biologic marketing exclusivity ends in year 12, stated Ms. Koblitz: “Biosimilar manufactursrs must then contest, settle or design around a wave of new patnets that become enforceable just as statutory exclusivity ends. This effectively shields secondary patents from scrutiny.”
The Eliminating Thickets to Increase Competition (ETHIC) Act (S.2276/HR3269) would “limit patent assertions for biosimilars and generics only to one patent for each patentably-distinct improvement made on the drug.” It would also invalidate all terminal patents in a group if one is invalidated, providing a mechanism for cutting through the patent thicket.
Through the Courts: The Usual Suspects
Mr. Cerwinski described the typical patent litigation journey today, which usually plays out in district court (“with judges who often have little technological expertise”). He said, “Under certain circumstances, the case can wind up in front of a jury, who have even less technological knowledge.”
The biosimilar-enabling legislation—the BPCIA—created “the patent dance,” where the reference manufacturer must assert whatever patents it intends to defend. “One cannot add later to this list, but it could be 40, 50, or 60 patents. Often, the biosimilar manufacturer seeks leverage to force a settlement, which allows the drug to get to market.”
“Generic and biosimilar companies have huge pressure to reduce the risk of patent litigation, both in terms of time and expense.
Rachel Goode, JD, Senior Vice President, and Head of Legal and Intellectual Property, Fresenius Kabi, described another legislative proposal that addresses patent abuse. The Preserving Access to Affordable Generics and Biosimilars Act (S.1096) would prohibit brand sponsors from compensating generic/biosimilar sponsors to delay market entry of a drug that could be substituted for a reference drug. It prohibits anticompetitive agreements in patent settlements, backed with civil penalties. Ms. Goode said that although these settlements intuitively seem to be anticompetitive, IQVIA data argue that they are procompetitive, by getting contested products to the market faster. According to IQVIA, mean savings was $5 billion to the healthcare system, or a $516 million median savings for each molecule that was the subject of such an agreement.
