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On May 5th, the US Patent and Trademark Office published an update to the Interim Guidance titled “May 2016 Subject Matter Eligibility Update” to provide its examining corps with additional guidelines for determining subject matter eligibility under 35 USC §101.

The publication includes a memorandum, “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection,” which “seeks to improve examiner correspondence with regard to subject matter eligibility rejections.” It was issued in response to public comments.

The story continues to unfold regarding the patent eligibility of diagnostics, a story that first made headlines in the fall of 2013. Back then, the District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection (“The Sequenom Decision”).1 The decision was noteworthy, because it had been made upon remand and direction from the Federal Circuit to examine the patent eligibility of diagnostics in light of the Supreme Court’s now infamous Myriad and Mayo decisions.

In an interesting case decided last week, the Federal Circuit ruled that it cannot address whether the US Patent and Trademark Office’s 2014 Interim Guidance on Patent Subject Matter Eligibility exceeds the scope of the Supreme Court’s decisions in this area.

In September 2014, the US FDA published its first edition of the so-called ‘Purple Book,’ with the rather lengthy title – ‘Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.’ This new publication, like its well-established ‘Orange Book’ counterpart, will list approved biologic drug products and also their biosimilar and interchangeable generic equivalents. However, the Purple Book is still in its infancy. As of this writing, the published information is far from complete. Furthermore, the FDA has been slow in publishing the necessary guidance documents. Will the new Purple Book rise to the challenge of providing the necessary bridge between the patent and regulatory systems governing biologics? Will the requirements for demonstrating biosimilarity and interchangeability for biosimilar drug products turn out to be too onerous? This commentary explores the regulatory challenges for the role of the Purple Book as the first biosimilars begin receiving FDA approval this year.

Both 2013 and 2014 had been roller coaster years for proposed patent reform legislation to curb abusive activities by non-practicing entities – so-called “patent trolls”. The roller coaster is again gaining momentum as House Judiciary Committee Chairman Bob Goodlatte (R-VA) reintroduced the “Innovation Act” (H.R. 9) on February 5th.

The revised Guidance is a step in the right direction by the PTO to simplify the somewhat cumbersome and confusing patent claim analysis set out in the previous guidance and memo documents. The Guidance is an attempt to consolidate the separate frameworks the PTO had previously created for analyzing the patent eligibility of claims relating to laws of nature, natural phenomena, and natural products, versus claims relating to abstract ideas. I agree with the PTO that it is important to have a guidance that “promotes examination efficiency and consistency across all technologies.”

Just last week the Federal Circuit affirmed the dismissal of a declaratory judgment in a patent case involving a biosimilar product. I found this case interesting for two reasons: (1) because the Court punted and failed to address the key question of whether a developer of a biosimilar must go through the complex patent infringement adjudication requirements of the Biologics Price Competition and Innovation Act (BPCIA) and (2) perhaps more interestingly, because the facts of the case suggest the FDA may be requiring full-blown Phase III human clinical trials for the approval of a biosimilar product. See Sandoz Inc. v. Amgen Inc., 2014-1693 (Fed. Cir. December 5, 2014).

Just a few weeks back the Federal Circuit decided an interesting patent infringement case in which the U.S. government waived its sovereign immunity from suit. In this case, the plaintiff, Iris Corporation, had originally brought suit against Japan Airlines Corporation for infringement of its patent on an electronic passport system. What is even more interesting about this case is that it involves 28 USC §1498(a). This is a little-known statute governing patent infringement activities by the United States government and the requirement to adjudicate such suits in the specially-created Court of Federal Claims. See Iris Corp. v. Japan Airlines Corp., 769 F.3d 1359, (Fed. Cir. October 21, 2014). […]

The Supreme Court is currently scheduled to take on only one patent case this upcoming term. On October 15th, the Court will hear oral arguments in Teva Pharm. USA, Inc. v. Sandoz, Inc., No. 13-854. This is an appeal dealing with important issues of patent claim construction. The central question before the Court is whether a district court’s factual findings on claim construction may be reviewed de novo by the Federal Circuit.

On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.