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In April, the Supreme Court heard oral arguments from Amgen and Sandoz (the generic manufacturing arm of Novartis) regarding interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which establishes an alternate pathway for FDA approval of biologics. See Sandoz Inc. v. Amgen Inc. (No. 15-1039, 15-1195). Two key issues were raised: whether a biosimilar manufacturer is (1) required to provide manufacturing information from their abbreviated biologics license application (aBLA) to the manufacturer of the original reference biologic (i.e., the reference product sponsor, or RPS) and (2) whether the biosimilar manufacturer can give the 180-day notice of intent to market the biosimilar (known as the Notice-of-Commercial Marketing) to the RPS prior to receiving FDA approval. The second question is perhaps the more interesting and financially important. If notice cannot be given prior to FDA approval, the RPS can potentially benefit from an additional period of market exclusivity because the generic would essentially not be able to market their product until 180 days after FDA approval.

Dr. Anthony Sabatelli, Partner at Dilworth IP, has co-authored an article published in the Organic Process Research & Development journal (OPR&D) with Dr. John Jasper of Molecular Isotope Technologies and Dr. Ann Pearson of Harvard University. The article, entitled “Process Patent Protection via Analysis of Stable Isotope Ratios,” considers “the possibilities afforded by stable isotope analysis for improving process patent protection in relation to pharmaceutical and other value-added products.”

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Dr. Anthony Sabatelli, Partner at Dilworth IP, will serve on a panel at the Digital Health Bootcamp hosted by HealthVenture. The event, which will take place from Friday July 7th through Saturday July 8th, was is designed to provide digital health start-up companies with access to leaders in the healthcare industry through a series of panels, workshops and other interactive learning programs. Dr. Sabatelli will sit on a Q&A panel which will answer questions related to customer interest and intellectual property protection.

Knowledge of, and interest in, the human microbiome has rapidly expanded in recent years: each week, there seems to be additional advancements in our understanding of the microbial communities that call our bodies home. As investigations into these microbial communities and their impact on our health continue to develop, many researchers have rightfully begun to untangle the web of microbial communities external to us (See Part VII, The Microbiology of the Built Environment). In particular, we have observed an increased interest in the microbial communities associated with agriculture and crops. Having a clearer understanding of agriculture-associated microbial communities, and how they can be manipulated and modulated, will play an increasingly important role in the safety and security of our food supply. In fact, we have seen several encouraging efforts devoted to the advancement of microbiome research in agriculture, and we expect to see a subsequent increase in the need for intellectual property protection in this space. Importantly, we also see a clear path forward for patent-eligible inventions in this historically challenging area. While this article will focus on agriculture and the microbiome, we have also observed an increase in the attention being given to livestock production and the microbiome. In an upcoming installment of The Emergent Microbiome, we will address the history, importance, and advancements with respect to this field of research and related intellectual property issues and challenges.

Washington Redskins fans have been doing touchdown dances for Tam, because while Tam was pursuing his cause, the Redskins team was trying to move the ball forward on their own appeal from the cancellation of a number of the teams REDSKINS registrations based on the same disparagement clause, on the basis that the mark is disparaging toward Native Americans.

e Connecticut House of Representatives passed S.B. 1056 Wednesday, June 7th, to “establish a working group to develop a plan to foster the microbiome sector in the state.” This bill, which will now go to the governor for consideration, aims to incentivize companies focused on microbiome science to locate to and/or pursue their projects in the State of Connecticut. It proposes that a working group be established to identify these companies, and, that among the incentives created would be an annual competition for start-up microbiome companies to take place in Connecticut. “At Dilworth IP we had early on identified the field of microbiome-based therapeutics as an up and coming research area,” Dr. Anthony Sabatelli, Partner and Chair of Dilworth IP’s Biotech and Pharmaceutical IP practice group, said, “we are very pleased that this Bill has passed the general assembly, because it demonstrates the State’s commitment to supporting this emerging technology area as an important part of Connecticut’s biotechnology future.”

n Rovalma S.A. v. Böhler-Edelstahl GmbH & Co. KG (decided May 11, 2017), the Patent Trial and Appeal Board (PTAB) recently had trouble with “phonons” and struggled to adequately explain why Rovalma’s phonon-laced process would have been obvious. The Federal Circuit concluded that the lack of a reasoned explanation warranted a remand. The decision continues a trend, discussed in our earlier article (insert link), in which the Federal Circuit insists on reasoned explanations rather than conclusory assertions of obviousness.

The Intellectual Asset Management (IAM) Patent 1000 has recognized Michael P. Dilworth, Managing Partner of Dilworth IP, as one of the World’s Leading Patent Professionals for 2017. IAM spends a five month period receiving feedback and written submissions from private practice lawyers and clients on the current state of the market in order to come up with a list of potential candidates for this distinction. The individuals on the final listing are determined by the substantial positive feedback received about them from multiple sources. Mr. Dilworth said that it is “an incredible honor to be recognized alongside so many of my notable colleagues who I hold in high esteem, and I consider this distinction to be a testimony to the reputation built by the whole team at Dilworth IP.”

Dr. Jonathan Schuchardt of Dilworth IP will be presenting an upcoming Strafford CLE webinar focusing on the evolving obviousness standard of the USPTO. Obviousness Standard: Leveraging Latest PTO and Court Guidance will be presented on Thursday, June 1st from 1:00 to 2:30 PM (EdT). The webinar will review the Federal Circuit’s recent decisions and their effect on the obviousness standard, discuss what level of “unexpected results” is now needed in light of these decisions, and offer strategies for successfully asserting obviousness in an IPR Proceeding. This is the fourth time Jon has been invited by Strafford to present on the continual developments in this area of U.S. patent law. Jon will be joined in this session by Barry J. Herman of Womble Carlyle Sandridge & Rice.

Recent decisions from the United States Court of Appeals for the Federal Circuit from 2016 and 2017 suggest a loosening grip and increasing flexibility of the two-part Mayo/Alice framework that has dominated the question of patent subject matter eligibility under 35 U.S.C. § 101. In fact, in 2014 after the Alice decision, just one Federal Circuit case addressing 101 challenges was ruled to have eligible claims. Although there were no 101 eligibility affirmations in 2015, there were five such cases in 2016 alone. Fewer than five months into 2017, there have now already been two 101 decisions from the Federal Circuit finding patent eligible claims (see Figure 1 and Table 1).