Apart from the carnage wrought by the ever-expanding scope of s. 101 rejections and the tightening of the written description requirement, there were still a number of events/trends in 2017 to applaud or at least to note as “worthwhile.” I am going to run through a brief summary of significant IP progress pretty much off the top of my head, without citing much case law, so this post does not become a law review article. Please refer to my 2017 posts to get the case cites and more context.
1. More supervision of various aspects of PTAB by the courts
The Fed. Cir. ruled that the burden of establishing invalidity of a challenged patent claim(s) remains with the challenger, whether the claim was original or added by amendment. At least, this suggests that the court is of the opinion that amendments should be more routinely permitted by the PTAB. Of course, it remains a possibility that the S. Ct. will rule that patents are a private right, that cannot be extinguished by administrative fiat, that would require deleting a big chunk of the AIA.
2. The Fed. Cir. has been liberal in its interpretation of the s. 103 standards imposed by KSR
Both the increased emphasis on the importance of secondary considerations – particularly expected results – and the requirement that the PTO provide a reasoned explanation for a s. 103 rejection were important steps in moderating the severity of the S. Ct.’s KSR decision. Remember that KSR did not require abandonment of the TSM test, and it seems to be making a steady comeback. Judge Bryson’s remarkably thorough analysis of the factual evidence supporting an assertion of unexpected results in the recent Allergan district court decision sends a message that, while the F. Cir. must defer to findings of fact, the facts must be correctly found. Finally, the Fed. Cir. made it clear that “inherent obviousness” must be supported by a full obviousness analysis.
3. Sensible and flexible venue standards are limiting forum shopping for plaintiffs
Although the law has not been completely settled in this difficult area, the E.D. Texas district court is already seeing the number of filings in its patent-friendly jurisdiction drop. Life science infringement suits are much more likely to be made –or end up in– in patent-experienced courts such as in Delaware or California. The Fed. Cir. in the recent Micron decision remanded for a full consideration of the equities of identifying the appropriate “residence” of the defendant, and cases on the verge of trial may be required to stay put no matter where the residence of the defendant turns out to be.
4. Anti-patent s.101 jurisprudence may have reached its high water mark
The Mayo/Alice test advanced upon claims to diagnostic tests–even though the S. Ct. said that Mayo did not involve claims to a diagnostic test. The PTO has expanded the limited Myriad ruling that isolated genes are natural products to create an entire landscape of patent-ineligible subject matter (like peptides) and, in at least one district court, even claims to compositions of matter were found to be patent ineligible (Fund Bros. rules). Method of medical treatment claims are hanging by a thread. On the software/business method side, courts are struggling to define “abstract idea.” The hopeful note is that the ABA IP Section, AIPLA and IPO have proposed amendments to s. 101 to cabin judicial exceptions to patent eligibility.
5. Scot Gottlieb has been confirmed as Commissioner of Food and Drugs (FDA Head)
He had been the Deputy Commissioner of Medical and Scientific Affairs at the FDA, and is an M.D. Conservative or liberal, it is satisfying to see a competent candidate in the wheelhouse of this important agency.
6. Andre Iancu has been nominated to be Director of the USPTO
Somehow, Trump’s crony-filled line-up of executive branch appointments included Inacu, a well qualified senior litigator from Irell and Manella. He may have conservative credentials in his background but he represented Ariosa, and that’s good enough for me (at least for now). Acting Director Mattal was probably overqualified for the job, and commentators argued that his interim appointment was not supported by the agency’s rules for succession. But let’s thank him for his service and hope for the best going forward.
Although it’s beginning to look a lot like Christmas, I hope you had a gourmet friends-and-families Thanksgiving. The ability and opportunity to worry about the state of IP law is enough to make me give thanks!