Initially, biopharma represented a small percentage of post-grant proceedings; however, that percentage is increasing. In particular, generic and biosimilar manufacturers are recognizing advantages of this pathway. The high success rates achieved so far are compelling: For biopharma IPR petitions that have reached a final written decision, 66 percent have resulted in some or all of the challenged claims being invalidated.
For biosimilar developers, post-grant proceedings represent a particularly promising strategy for clearing a path through competitive patents. By the time biosimilars are nearing marketing, many of the composition-of-matter patents covering brand-name biologics are close to expiry. That leaves follow-on patents, such as those covering formulations or specific dosing regimens, for the biosimilar developer to work around, possibly by invalidating them. Technically trained judges on the PTAB may be more able than a lay jury to assess these patents without being dazzled by the success and complexity of the underlying biologic and therefore may be more willing to find that modifying a formulation or selecting a dosing regimen was not inventive.
When it comes to biosimilars, post-grant proceedings offer other advantages relative to litigation, including:
- While only the biosimilar applicant can challenge a patent under the Biologics Price Competition and Innovation Act (BPCIA), and only within the strict guidelines of the BPCIA, in post-grant proceedings any party (other than the patent owner) can initiate a challenge, and the challenge is not tied to the biosimilar approval process. Accordingly, filing a post-grant proceeding can allow a biosimilar developer to potentially clear blocking patents—or at least determine the strength of patent protection covering the reference product—earlier in the biosimilar development pathway, before making a major investment in developing a biologic.
- Additionally, post-grant proceedings are generally faster and less expensive than litigation, partly because post-grant proceedings have a set timeline, and also because the scope of discovery is extremely reduced relative to litigation. Moreover, because of the strict timeline, courts will frequently stay any concurrent litigation until the post-grant proceeding is decided.
- Post-grant proceedings also offer several significant substantive advantages relative to litigation for the party challenging a patent, including a lower standard of proof (‘‘preponderance of the evidence’’ instead of ‘‘clear and convincing evidence’’), a broader standard for claim construction (‘‘broadest reasonable interpretation’’ instead of ordinary and customary meaning in light of the claims, specification and prosecution history) and a different judge and jury (an Administrative Patent Judge used to finding patents to be unpatentable while performing both functions, instead of a district court judge and jury who are not so experienced at splitting those functions). All these differences serve to shift the scale toward the challenger at the PTAB, making this an attractive forum for biosimilar developers.
There are, of course, other considerations. IPR challenges to biopharma patents, for example, are instituted at a lower rate than challenges to patents in other technology areas. Further, IPR challenges are restricted to unpatentability shown through prior art patents and printed publications. Thus, an IPR may not be right in every case, reinforcing the importance of consulting with patent counsel well versed in all the options when deciding how to clear patent hurdles when bringing a biosimilar to market.
Read more in our recent article, Impact of Post-Grant Proceedings on Biologics and Biosimilars, published in Bloomberg BNA’s Life Sciences Law & Industry Report.