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As we have discussed in previous installments of “The Emergent Microbiome,” we have seen a distinct growth in the interest of the microbial communities found in our environment beyond the confines of the human body. Earlier articles in this series have focused on the microbiology of the built environment (See Part VII: The Microbiology of the Built Environment) and the microbial communities of plants that have been characterized and manipulated to maximize their growth and crop yield (See Part XI: Agriculture and the Microbiome). In both circumstances, we noted robust intellectual property activity. Likewise, we have also observed an increased interest in the microbial communities found in livestock animals, and how manipulations of these communities could result in more effective, productive, and sustainable means of food production. Although this area is less well developed than other areas of microbiome research, including that of plant agriculture, we see it as a promising area of development in terms of both the science and the innovation that will inevitably flow from it.

In 2001, the first entire human genome was successfully sequenced under the support of the Human Genome Project. This endeavor took 15 years and cost nearly 3 billion dollars. Since then, high-throughput sequencing technology, also known as Next Generation Sequencing (NGS), was developed to reduce the time and cost of human genome sequencing. In 2005, the first NGS sequencer was released to the market by 454 Life Sciences.  This sequencer reduced the cost of human genome sequencing by 50,000-fold.

Dilworth IP is excited to announce that we have formed a strategic affiliation with fellow intellectual property firm, Dilworth & Barrese.  With this new affiliation both firms will offer their respective current and future clients a broader array of technical and legal expertise. 

On May 30th, the Supreme Court ruled in Impression Products, Inc. v. Lexmark International, Inc. that all patent rights are automatically exhausted upon the sale of a product irrespective of contract stipulations and regardless of whether the sale is made domestically or internationally. While the dispute in this case involved articles of manufacture, the decision has strong implications for the biotechnology and pharmaceutical Industry, and may make it easier for drugs sold legally overseas to make their way back to the US market.

Although the focus of most of our pieces has been on U.S. patent law, there is occasion to report on developments of note from abroad.  One such patent case decided last month in Great Britain deserves our attention.  On July 12th, the United Kingdom Supreme Court (UKSC) redefined patent infringement laws as related to infringement by equivalents, i.e. under what we know here in the U.S. as the “Doctrine of Equivalents”.  To elaborate, under this doctrine, a party can be found liable for patent infringement even though the accused item or process does not fall within the literal scope of a patent claim.  The current legal test in the U.S. determines whether the difference between the accused item or process and the patent claim is “insubstantial” so that it is equivalent to an invention falling within the scope of the claim.  See Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997).  Although well established in the U.S., the doctrine has been anathema under U.K. law.

In Millenium Pharmaceuticals Inc., v. Sandoz Inc., 2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1283, 2016-1762 (Fed. Cir. July 17, 2017), the Federal Circuit pulled no punches in overruling the Districts Court’s finding of patent invalidity for U.S. Patent No. 6,713,446 (446 Patent), exclusively licensed by Millennium.  The case related to Velcade®, used in chemotherapy for the treatment of multiple myeloma.  Such was the drug’s effectiveness that it “changed the decades-old standard of care for multiple myeloma and has saved thousands of lives.

In a nonprecedential, but nevertheless interesting case concerning several patents related to digital rights management for computers and other devices, the Federal Circuit in ContentGuard Holdings, Inc., v. Apple Inc., 2016-1916, 2016-2007 (Fed. Cir. July 12, 2017), agreed with the District Court’s construction of the claims, where both Parties’ proposed constructions had been rejected.1 The suit involved several of ContentGuard’s patents: U.S. Patent No. 6,963,859 (859 Patent), U.S. 7,823,072 (072 Patent), U.S. Patent No. 8,370,956 (956 Patent), U.S. Patent No. 8,393,007 (007 Patent), and U.S. Patent No. 8,001,053 (053 Patent), and alleged infringement by Apple.2 Ultimately, the District Court entered final judgement in favor of Apple.3

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.”

To download the full text, Click Here

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.