Will Biosimilar Manufacturers Have to Wait? Sandoz Petitions Supreme Court for an Answer

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.

Michael Dilworth Receives 2016 Client Choice Award

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.”

The Emergent Microbiome: A Revolution for the Life Sciences – Part V, Patents Relating to Obesity and Metabolic Disorders

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.

The Emergent Microbiome: A Revolution for the Life Sciences – Part IV, Obesity and other Metabolic Disorders

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.

Upcoming Free Webinar on Patent and Regulatory Issues for Pharmaceuticals

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.

Dilworth IP’s Dr. Schuchardt Featured in the IP Litigator

Dilworth IP’s Dr. Jonathan Schuchardt has recently had an article published in the bi-monthly publication IP Litigator. His article, entitled “The Federal Circuit Sees Nova’s Light,” considers the effects of the Supreme Court’s decision in Nautilus Inc. v. Biosig Instruments, Inc. on the issue of “indefiniteness,” especially with regard to previous cases involving patents filed by Dow Chemical.

Dilworth IP Partners Speaking on IP Basics to the Start-up Community

Dr. Anthony Sabatelli, chair of Dilworth IP’s Pharmaceutical and Biotechnology group, and Mr. Frederick Spaeth, who leads the Firm’s trademark practice, will together be presenting two upcoming talks on the basics of Intellectual Property law geared toward entrepreneurs and inventors. The first of these will be on Thursday, January 21st [time?]at the University of Connecticut’s Technology Incubation Program (TIP) in Farmington, CT; the second will be the following day, Friday, January 22nd, [time?] at Yale University’s Entrepreneurial Institute (YEI), for which Dilworth IP is a corporate partner, in New Haven, CT. Anthony and Fred will be discussing key events over the life of a patent, common concerns of the patent process, and patentability in biotechnology and IT/software. Admission to both events will be free, but early registration is required.

Dr. Jon Schuchardt of Dilworth IP to Speak at Strafford Webinar on Obviousness

Dr. Jonathan Schuchardt of Dilworth IP will be presenting an upcoming Strafford webinar focusing on the evolving obviousness standard of the USPTO. Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance – Overcoming Challenges of Obviousness and Attacks on Patent Validity will be presented on January 21, 2016 from 1:00 to 2:30 PM (EST)

Theresa Doonan of Dilworth IP to Participate in Panel on CT’s Opiate Crisis

Dilworth IP’s Senior Patent and Trademark Paralegal, Theresa Doonan, will be participating in a panel discussion on Connecticut’s opiate addiction crisis this Monday, January 11th at Sacred Heart University in Fairfield, CT. Theresa is the co-founder of the Connecticut Heroin Task Force and HeroinKillsCT which were each founded to address and actively respond to the growing epidemic of heroin addiction in Connecticut