Three Patent Issues to Watch in 2015

07 January 2015 PharmaPatents Blog

Well, 2014 was a busy year in patent law, and it wasn’t all good news for patent holders. The Supreme Court made 35 USC § 101 a significant hurdle to patenting inventions across a broad swath of technologies (see my post on the Alice decision here), gave more teeth the definiteness standard of 35 USC § 112 (see my post on the Nautilus decision here) and did not resolve the divided infringement problem (see my post on the Akamai decision here). For its part, the Federal Circuit expanded the reach of the doctrine of obviousnesss-type double patenting, invalidated antibody claims defined functionally, scrutinized evidence of unexpected results, and questioned whether post-filing date evidence can be used to support non-obviousness. Now that all that is behind us, here are the biggest issues that I expect to be watching in 2015.

Patent Eligibility

I think patent eligibility will continue to be a major issue for patents in the chemical, biotechnology, and pharmaceutical space in 2015. While the revised guidance the USPTO issued December 15, 2014, seems to be a step in the right direction after the drastic positions taken in the March 4, 2014 Guidance, it remains to be seen how examiners will apply the new analytical framework, especially in applications where they already have made 35 USC § 101 rejections under the old guidance. For inventions in the diagnostic and personalized medicine space, Federal Circuit decisions like that in the recent Myriad decision may be more problematic than the USPTO’s position.

Biosimilars

March will mark five years since the effective date of the Biologics Price Competition and Innovation Act, and I believe that 2015 may bring the first approval of a biosimilar product, and the first patent litigation under the complex framework of 42 USC § 262(l). While several would-be biosimilar applicants have tried to avoid those convoluted procedures by bringing declaratory judgment actions before filing their biosimilar applications, the Federal Circuit has not found a sufficient case or controversy to support jurisdiction under those circumstances. However, now that at least one biosimilar application has been filed, we are bound to see some litigation under § 262(l), or at least litigation regarding its contours.

Inter Partes Review and Post Grant Review

While the majority of Inter Partes Review (IPR) proceedings have not involved chemical, biotechnology, or pharmaceutical patents, I think more stakeholders in these fields will take advantage of this option for invalidating third party patents, especially as they see the high invalidation rates continue, and realize the impact that the lower burden of proof and the USPTO’s broader claim construction can have on an invalidity challenge.

In 2015, we might see the first bubble of patent applications filed after March 15, 2013 get granted, and it will be interesting to see how many are challenged in a Post Grant Review (PGR) proceeding. Stakeholders in the chemical, biotechnology, or pharmaceutical fields may be more interested in PGRs than IPRs, particularly where written description and enablement issues are more relevant to validity than prior art, but will have to act quickly to challenge patents within the nine-month post-grant window of 35 USC § 321(c).

We also should see decisions from the Federal Circuit regarding the USPTO’s interpretation and application of the IPR statute, such as whether the PTAB should apply the “broadest reasonable interpretation” of the claims, or should construe the claims as a district court would.

I will be following these and other patent issues in 2015, and look forward to sharing my insights in the months ahead.

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