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Dr. Anthony Sabatelli and Dr. Jing Zhou of Dilworth IP presented a talk entitled “Pharmaceuticals: At the Intersection of Patent and Regulatory Law” at the SAPA-CT 4th Annual Conference on Saturday, October 7th. The Sino-American Pharmaceutical Professionals Association (SAPA) was founded in 1993 as an independent and nonprofit organization seeking to bridge the U.S. and Chinese pharmaceutical worlds by providing training in drug research and development, creating a broad network, and hosting delegations from China. The theme of this year’s conference was “Adapting to the Changes in Biotech/Pharmaceutical Industry” and was held at the Yale School of Management from 8:00 am to 6:30 PM.

Frederick A. Spaeth, Partner at Dilworth IP, will be hosting a FREE webinar on Wednesday, November 1st at 1:00 PM (EDT). This installment in the Dilworth IP Webinar Series is entitled Strategic Approaches for Drafting NDAs: A Critical Look at ‘Standard’ Clauses and Current Trends – A 2017 Update, and will focus on providing helpful strategies for properly structuring Nondisclosure Agreements (NDAs). NDAs are used everywhere: in business, politics, religious organizations, government, etc. Templates are easy to find, but experienced users will attest that there is no universal ‘standard’ NDA. In practice, an NDA should be tailored to the situation at hand and to meet the needs of the parties involved. Otherwise, the parties may be left with an ill-fitting agreement that doesn’t reveal its flaws until a dispute is brewing. This webinar will take listeners beyond a ‘one-size-fits-all’ view for a detailed look at how an NDA can and should be structured. The discussion will touch on choosing clauses to insist on and those to let go, on agreement language that goes without saying but should sometimes be said nonetheless, on non-standard clauses for specific situations, and on recognizing when the terms needed in an NDA may be dictated by external factors. The influences of recent laws, such as DTSA (Defense of Trade Secrets Act of 2016), will be discussed as well.

Senator Orrin Hatch (R-UT), Chairman of the Senate Republican High-Tech Task Force and Former Chairman of the Senate Judiciary Committee, recently wrote an op-ed article on patent reform. Hatch has made significant contributions to the law, including defining generic drug regulation via the Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act, as well as contributing to the America Invents Act (AIA).

Antibiotic resistance is a major problem in the United States and is considered by the World Health Organization (WHO) to be one of the largest threats to human health. The top 12 bacterial threats classified by WHO are shown in Table 21. Researchers are going so far as to send antibiotic resistant bacteria into space in order to determine how the bacteria mutate, with the thought being that in space, bacteria will mutate at an accelerated rate, making it easier to study bacterial resistance patterns and, therefore, develop better antibiotics that are active against resistant bacterial forms.

Dr. Jonathan Schuchardt of Dilworth IP will be presenting an upcoming webinar focusing on the evolving obviousness standard of the USPTO for the Clear Law Institute. Not So Obvious: How the Federal Circuit Interprets 35 U.S.C. § 103 will be presented on Friday, October 6th from 1:00 to 2:15 PM (EDT).  CLEs are available for attending this webinar through the Clear Law Institute.

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.