Greenblum & Bernstein, P.L.C.
Recent News in Intellectual Property
In This Issue:
· Sequenom’s Petition for Supreme Court Review Denied
· Supreme Court defers decision on certiorari petitions in Amgen v. Sandoz
· The DTSA of 2016: Another Tool for Protecting Biotech IP
· USPTO to Expedites Cancer Immunotherapy Applications
Walter Schlapkohl, Ph.D., Esq.
On June 27, 2016, the Supreme Court denied Sequenom, Inc.’s petition for writ of certiorari and rendered the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. the final word in a closely watched patent subject matter eligibility case.
In June of last year, the Federal Circuit reluctantly affirmed a lower court’s ruling of summary judgment of invalidity of claims asserted by Sequenom against Ariosa Diagnostics, Inc., Natera, Inc., and DNA Diagnostics Center Inc. The asserted claims were directed to, among other things, methods of using cell-free fetal DNA from maternal blood or serum samples for pre-natal diagnosis.
More than 20 amicus briefs from a diverse set of stakeholders and interested parties were submitted in support of Sequenom’s petition.
With its denial, the Supreme Court appears to have passed over a critical opportunity to clarify the bounds of patent subject matter eligibility in view of its prior decisions, particularly its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. Indeed, in a remarkable concurrence from the Federal Circuit’s opinion, Judge Linn highlighted the “meritorious” nature of Sequenom’s invention and stated that “But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”
Supreme Court Defers Decisions on Petitions for Certiorari in Amgen v. Sandoz
On June 20, 2016, the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States in the Amgen v. Sandoz case, the Federal Circuit’s first substantive ruling relating to the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Petitions for certiorari from the Federal Circuit’s decision had been filed by both Amgen and Sandoz. Extension of an invitation to the Solicitor General, also known as a CVSG (“call for the views of the Solicitor General”) may indicate an interest in the case by the Supreme Court in the matter that, if confirmed by a recommendation of grant by the Solicitor General, would render Supreme Court review much more likely.
In Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015), the Federal Circuit held that (1) Sandoz did not violate the BPCIA by failing to disclose its abbreviated Biological License Application and manufacturing information to Amgen (the reference product sponsor), and (2) that a biosimilar applicant may only provide effective notice of commercial marketing of its biosimilar after the FDA has licensed its product.
The reference product and biosimilar at issue are Neupogen® filgrastim and Zarxio® (filgrastim-sndz), respectively.
The Defend Trade Secrets Act of 2016: Another Tool for Protection of Biotech IP
On May 11, 2016, the Defend Trade Secrets Act of 2016 (DTSA) was signed into law by President Obama. The DTSA creates a federal civil remedy for trade secret misappropriation where the trade secret “is related to a product or service used in, or intended for use in, interstate or foreign commerce.” Under extraordinary circumstances, parties victim to misuse or misappropriation of trade secrets can sue not only in federal court for trade secret theft, but also seek a civil seizure order from the court to prevent the “propagation or dissemination” of the trade secret.
To obtain a seizure order, the court must find, among other things, that an “immediate and irreparable injury will occur if such seizure is not ordered,” that the information is, in fact, a trade secret, and that the person against whom seizure would be ordered misappropriated the trade secret “by improper means.”
The DTSA was introduced by Sen. Orrin Hatch (R-Utah) with the hope of protecting billions of dollars each year lost to trade secret theft.
Biotechnology companies may be uniquely situated to take advantage of the newly enacted law. Patent protection for many life science inventions has been complicated by recent case law relating to patent subject matter eligibility of products of nature and natural phenomena. Moreover, the complex processes that are often required to produce or manipulate biologics and other bioproducts often require a good deal of tweaking and optimization. Such processes may lend themselves to enhanced trade secret protection, particularly such processes requiring third- or multiple-party access to the trade secret.
The USPTO Will Expedite Cancer Immunotherapy Applications
On June 29, 2016, the USPTO announced that it would begin the “Cancer Immunotherapy Pilot Program,” a one-year pilot program that will allow for expedited review of patent applications in the field of cancer immunotherapy. The program is part of the $1 billion initiative by the Obama Administration known as “National Cancer Moonshot.”
Applicants who file a grantable petition to make a cancer immunotherapy-directed application special under the pilot program will obtain examination out of turn with the objective of completing examination within one year.
Petitions for the pilot program must be filed before June 29, 2017.