I will try to keep this post as brief as possible, since I posted at length on all of the stories. There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in 2014. In no particular order, I pick:
1. Ariosa v Sequenom. This Fed. Cir. decision that a method for isolating “cffDNA” from maternal blood is no more than a natural phenomenon was a big step backwards for the development of patent law in the area of “precision medicine” and clouds the future patent-eligibility of both natural products and methods of diagnosis and treatment. It is a pick to click with the Supreme Court. (There was also a PTO “July 2015 Update” of the December 2014 s. 101 Guidelines that really did not clarify anything.)
2. Biosimilars Hit the Shelves. In April, the FDA finalized its biosimilars guidance and Sandoz soon launched the first biosimilar, a generic version of Neuprogen.
3. Nautilus v Biosig. The Supreme Court redefined the “indefiniteness standard” of s. 112(2) so that a claim term must be reasonably certain to the POSA, not simply amenable to construction. In Dow v. Nova, this new standard compelled invalidation of the claims-in-suit.
4. The Rise of the PTAB. While it seems clear that the Fed. Cir. does not want to review every decision made by the PTAB in IPR, it released important decisions relating to its authority. In re Cuozzo, the court preserved the application of the PTO’s broadest reasonable claim construction rule in IPRs. In Merck v. Gnossis, the court affirmed that it would review PTAB decisions under the deferential “substantial evidence” standard, and not review PTAB decisions for proper application of the preponderance of the evidence standard.
5. Obviousness Post-KSR. With the Supreme Court’s rejection of the teaching-suggestion-motivation by the art requirement, the Fed. Cir. has been developing the legal standards around obviousness questions derived from decisions that the Supreme Court left intact. These include a greater reliance on evaluating whether or not the art “teaches away” from the claimed invention, and evidence tending to show that hindsight was employed by the lower court or the Board. Closer evaluations of secondary considerations such as commercial success, failure of others, long-felt need, etc. are appearing in recent decisions. For example, see Judge Newman’s dissent in Merck v. Gnossis, Appeal no. 2014-1779 (Fed. Cir. 2015); see also Shire v. Anneal.
6. Teva v. Sandoz Reverses Cybor. Fed. Cir. can still review questions of law de novo, but must give deference to the lower court’s findings of fact.
7. Kimbel v. Marvel. In this “Spiderman” decision, the S. Ct. upheld the viability of Brulotte v. Thys: “No royalties for you” patentee/licensee, after the patents have expired. Impact: not huge, since patentees have been designing work-arounds for years.
8. The Gradual but Steady Demise of Invalidations Based on Inequitable Conduct. Even though the decisions on appeals post-Therasense affirmed findings of IC about half the time, there were no important decisions involving IC in 2015. Either it is being pled less or being dismissed earlier in the proceedings. The Fed. Cir. earlier had upheld the invalidation of an Apotex patent, and Apotex has petitioned for cert., calling the Therasense decision just one more rigid Fed. Cir. rule, but I don’t think the Supreme Court will bite.
9. The Gaggle of Decisions on Divided Infringement. This includes Akami v. Limelight (direct infringement can involve multiple actors if one “mastermind” controls their actions), Commil v. Cisco (belief in invalidity does not negate intent to induce infringement), Life Techs. Corp. v. Promega (self-active inducement under 271(f)(1)) and others that never quite captured my interest.
10. The Trans-Pacific Partnership. According to Republicans, one more thing that President Obama got wrong.
So Happy New Year to All! 2016 Promises to be equally interesting – as in the old Chinese curse – “May You Live in Interesting Times.”