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Dr. Anthony Sabatelli & David Puleo will be presenting a free webinar on Thursday, April 19th at 1:00 PM (ET) for Dilworth IP, entitled, “Just What is the Federal Circuit Thinking? A Path Forward Amid Subject Matter Eligibility Variability.” Tens of millions spent on product development – how do you protect your company’s technology in an environment where the Federal Circuit redefines patent eligible subject matter on nearly a weekly basis, and where the USPTO’s application of these judgments is just as inconsistent? Is subject matter eligibility no longer a question of law and is it now morphing into a question of fact?

On Wednesday, President Obama signed the Defend Trade Secrets Act. His action follows the bill’s passage in Congress, which we previously reported here: /trade-secrets-bill-passes-house-goes-white-house/

In a signing ceremony in the Oval Office, President Obama recognized the legislation’s historic importance, commenting that the law “for the first time will provide civil actions for companies or individuals that are stealing trade secrets from our American innovators[1].”

On Wednesday, April 27, the House of Representatives voted 410-2 to approve the Defend Trade Secret Act (S. 1890). The bipartisan measure, which is supported by the White House, is expected to be signed into law in the coming days.

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).