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On October 26, 1881, Wyatt Earp and his brothers, Morgan and Virgil, along with Doc Holliday met with Ike and Billy Clanton, Tom and Frank McLaury and Billy Claiborn, to engage in a form of conflict-resolution in a vacant lot off Fremont Street in Tombstone, Arizona Territory. Sheriff Johnny Behan’s efforts at mediation were ultimately unsuccessful, and the rest is history. The dispute between the parties had been long-standing, and it is not clear that there was a defining moment that made the final confrontation a certainty. Such cannot be said of the Federal Circuit’s holding in Lexmark International, Inc., v. Impression Products, Inc., No. 2014-1617, 2014-1619 (Federal Circuit, February 12, 2016)(en banc). In this decision, the Federal Circuit has undoubtedly set the stage for the Supreme Court to resolve issues related to Patent Exhaustion.

This is the first article in a review of patents issued in 2015 in the area of Fluid Catalytic Cracking (FCC). The summary below covers five patents relating to FCC catalyst additives. These include: two related to gasoline sulfur reduction catalysts; two related to metals deactivators/traps; and a ZSM-5 additive patent. Review of this collection of patents illustrates a somewhat subdued activity in additive research activity for the FCC, at least that devoted to patentable activities. To be fair, there are almost double the number of “catalyst” related patents, and some of these are directed to olefin production, which would boost the number in the olefin/octane area. These will be summarized next month. For the sulfur reduction and metals trapping areas, time will tell whether there is a resurgence in these areas.

Dilworth IP will be sponsoring the 2016 Yale Healthcare Case Competition which will be presented by Jackson Laboratories and held Saturday February 27 in Evans Hall at the Yale School of Business

Dilworth IP Partners Dr. Anthony Sabatelli and Mr. Frederick Spaeth will be presenting a talk on Intellectual Property basics at the Quinnipiac University Center for Innovation and Entrepreneurship on Friday March 4th at 12:00 PM. The talk will be geared toward prospective inventors and entrepreneurs and will cover key events over the life of a patent, common concerns of the patent process and patentability in biotechnology. For more information on the event, please contact QUCIE@quinnipiac.edu.

Last week, Sandoz, the generic pharmaceuticals division of Novartis, petitioned the Supreme Court to review a Federal Circuit decision concerning a case involving Zarxio, its biosimilar version of Amgen’s Neupogen. At issue is the court’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA establishes an alternative pathway for FDA approval of biosimilars and patent-dispute resolution, allowing litigation prior to FDA approval and marketing of biosimilars.

Dilworth IP welcomes Dr. Jing Zhou, a Technology Specialist who will be supporting the biotech and medical device practice areas of the firm.

Dilworth IP is proud to announce that Michael Dilworth has received the 2016 Client Choice Award for Excellence in Client Service for Patents. He recently accepted the award at a gala dinner held in London to honor all of this year’s recipients. As Michael noted, “It is an honor to receive this award on behalf of the entire Dilworth IP team, without whom I’d never have this opportunity. I am proud of my team and the recognition from our clients’ of the outstanding professionalism and client service that we constantly strive for at Dilworth IP.”

This is the fifth installment in a series on advancements in microbiome research and development. This article will summarize issued U.S. microbiome-based patents that describe therapies relating to obesity and other metabolic disorders. It is a follow-up to the fourth part of the series, which reviewed important research and development in this subject area. The patents reviewed herein are neatly summarized in the table at the end of this installment.

The diet and nutrition industry is big business: the industry brings in over $60 billion dollars from the nation’s 100 million-plus dieters. Yet, years of R&D have failed to produce a blockbuster weight loss drug. Clearly, there is a big incentive to develop new and effective therapies for this area, particularly considering the risks and adverse events that have plagued previous prescription therapies, and companies are looking to the untapped potential of the microbiome for an elusive wonder drug.

Some of the earliest evidence for the relationship between the microbiome and obesity came from studies of antibiotics and their association with weight gain in livestock, which pointed to a link between microbiome composition and weight maintenance. A 2006 study from the laboratory of the prominent researcher Jeffrey Gordon uncovered a mechanism by which some gut bacteria trigger obesity. Lead author Peter Turnbaugh and his colleagues noted that obese mice had different microbiomes than their lean littermates. The same was true of lean and obese human twins. When Gordon’s team characterized this phenomenon, they found that the microbiomes in obese mice and humans obtain more calories from food as compared to the microbiomes of their lean counterparts. In addition, when the researchers transferred the gut bacteria of an obese mouse to a germ free one, the formerly germ free mouse became obese.

Dr. Anthony Sabatelli, head of Dilworth IP’s Pharmaceutical and Biotech Patent Practice, will be hosting the second of this year’s Dilworth IP Webinar Seminars. This session, entitled At the Intersection of Patent and Regulatory Law – Navigating the Challenges for Pharmaceuticals, will address the special challenges pharmaceutical products present for companies and their multidisciplinary teams. These challenges exist because pharmaceuticals, unlike most other chemical products, sit at the intersection of patent and regulatory law. In this webinar, Dr. Sabatelli will provide a basic introduction to the applicable patent and regulatory laws, focusing on their interplay over the product life cycle of a pharmaceutical product, from its inception in the lab, through R&D, human clinical testing, marketing, and eventual generic competition. Concepts such as patent term extension (35 USC 156), and the regulatory and market exclusivity periods granted upon approval of a NDA (21 USC 355) will be discussed. An example of a timeline for a pharmaceutical product will be presented to illustrate the fascinating interplay of these concepts and their importance for those multidisciplinary teams needing to make high stakes business decisions.