With more than 6,000 IPRs having been filed since Sept. 16, 2012, and roughly 9 percent of those being filed in the biotech or pharmaceutical fields, the PTAB (Patent Trial Appeal Board) has become an active venue for adversaries in the life sciences. Patents relating to both small and large molecules have been challenged, including patents on well-known drugs such as Humira, Herceptin, Restasis, Vigamox, Rituxan, etc. And the petitioners span the gamut, from ANDA filers, to biosimilar applicants, innovator competitors or non-practicing entities. Some examples are: Merck, Amgen, Mylan, Boehringer, Ingelheim, Hospira, the Coalition for Affordable Drugs and others. Below, we provide five PTAB tips for big pharma.
1. Be Prepared
Big pharma patents now can expect IPRs or PGRs. Prudent patent owners thus prepare early on to defend their important patents. This includes fortifying the company’s patent portfolio and creating a thicket of protection around core assets. This isn’t just a numbers game. Rather, thoughtful patent owners seek to build their portfolios from every angle, e.g., taking into consideration clinical trial results, competitor’s activities, manufacturing methods, etc. And, patent owners should not automatically recoil at the idea of robust prosecution. A prosecution file history that provides a compelling patentability story in the face of the most pertinent art, and which includes declarations and objective indicia evidence, may be the best shield against a successful post-grant challenge. It’s now more important than ever to draft applications carefully, providing clear definitions of important claim terms. Also, while patent owners involved in post-grant challenges at the PTAB may submit declarations to support their preliminary responses, such declarations have not generally been effective to avoid trial, underscoring the importance of strong prosecution. In the event of a post-grant challenge, patent owners should consider using Track 1 applications to expedite prosecution of related cases, before any patent owner’s estoppel might arise. And because amending claims during an IPR or PGR is rarely successful, it is wise to keep an application pending. Failing that, patent owners can consider reissue strategies.
