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There has been a lot of recent buzz about chimeric antigen receptor (CAR) T cell technology.  Novartis and Gilead have FDA-approved CAR-T therapies offering complete patient remission from certain cancers.  A flood of new CAR-based technologies is likely to hit the market.  As with any novel therapy, patent protection is essential.  The large number of patent filings suggest that intellectual property protection is an important part of the research efforts in this field.  The bolded patent documents cited in this article are further summarized in the table at the end of this installment.

Over three decades ago, the United States Congress passed the Drug Price Competition and Patent Term Restoration Act[1]. This piece of legislation, known as the Hatch-Waxman Act, tackled the difficult task of protecting pharmaceutical innovator intellectual property while ultimately providing increased competition and decreased cost to consumers through accessible generic drugs. This legislative task was accomplished with two pieces of intersecting laws:  (i) the patent provisions under 35 USC which provide for up to five additional years of patent term extension and (ii) the drug exclusivity provisions under 21 USC 355 which provide certain regulatory and marketing exclusivity periods upon drug approval.  The intersection of these patent and regulatory/marketing exclusivity periods provide innovator drug developers with a net exclusivity period. Given the immense monetary and time investment for developing new drugs, maximizing this net exclusivity should be a major focus of patent practitioners in the pharmaceutical field. By maximizing this net exclusivity, innovator drug developers can recoup their investment, as well as provide a stable foundation and incentive for continued drug discovery. To understand how to maximize this window, those involved need to understand the important role this intersection of patent and regulatory law holds.

Three recent articles in Science discuss how the composition of the gut microbiome affects anti-PD-1 therapy for the treatment of melanoma, metastatic melanoma, and epithelial tumors, further bolstering the idea of gauging immunotherapeutic efficacy based on one’s microbiome composition.  We first reviewed this concept in Part VIII of The Emergent Microbiome Series and are revisiting it here.  Bolded patent documents are further summarized in the table at the end of this installment.

Since the start of the year, the CAFC has handed down four cases in rapid succession relating to patent subject matter eligibility – the precedential Finjan vs Blue Coat, Core Wireless vs LG electronics, and Berkheimer vs HP Inc. decisions and the non-precedential Move Inc. vs Real Estate Alliance decision.  In each, the validity of patents relating to software inventions was challenged, in part on the grounds that the inventions covered abstract ideas (an ineligible subject matter under 35 U.S.C. § 101).  In the first three cases released (Finjan, Core Wireless, and Move Inc.), the CAFC displayed refreshing consistency in their evaluation of the ‘abstractness’ of patents, offering a glimmer of hope that the court may finally be offering a clear path forward, in particular with regards to step one of the Alice/Mayo test.  Unfortunately, that hope was dashed in Berkheimer, in which the CAFC reverted to a different procedure for evaluating the abstractness of patents.  This inconsistency in the application of the Alice/Mayo test sows confusion in the patent field, and continues to make the drafting of ‘101 – resistant’ patents more difficult.

Matthew Siegal, a patent attorney with Dilworth IP’s affiliate firm, Dilworth & Barrese, and Of Counsel to Dilworth IP, was quoted in an article published by Law 360 entitled, “From NJ to Texas: How the Courts Fared at The Federal Circuit.” Mr. Siegel commented on the District of Delaware’s high affirmance rate with the Federal Circuit in patent cases, saying, “They’ve learned how to quote the standards and base their decision on alternate theories, some of which they know are less likely to be reversed.”

The United States Chamber of Commerce (USCC) released the 6th Edition of the International IP Index on its Global Intellectual Property Center (GIPC) website last week.  The Index highlights the importance of establishing a strong intellectual property infrastructure to catalyze economic growth, development, and innovation.

In previous installments of Nanomedicine, we have discussed the usage of nanoparticles in cancer and other diseases as both diagnostics and therapeutic agents. See, for example, magnetic nanoparticles for theranostics (Part VIII and Part X), quantum dots for bioimaging (Part VII), nanoparticles as cancer biomarkers (Part VI) and for cancer therapy (Part V), and nanoparticles as drug delivery carriers (Part IV).  These applications of nanotechnology not only have attracted increased attention from pharmaceutical companies and academic researchers, but have led to the development of innovative candidatesin clinic trials and even successful products selling in global markets. Beyond this thriving therapeutic field, another huge market for utilizing nanotechnology that might not be as widely recognized, but which already has had a great impact, is the market for cosmeceuticals.

The Food and Drug Administration (FDA) made a technical change to the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)[1], effective November 21, 2017. The Orange Book will now show patent submission dates where available. A patent submission date is defined as the date on which the FDA receives patent information from the New Drug Application (NDA)[2]  holder, often referred to as the innovator. Previously, patent submission dates could only be ascertained by directly contacting the FDA.

Developments on the topic of patent subject matter ineligibility continue to progress rapidly.  In this piece we revisit the Federal Circuit Court decision in Two-Way Media v. Comcast.  This case provides comments in part on the role the patent specification should play when looking for inventive concepts in the second step of the Alice/Mayo test.  Two-Way also serves as an important reminder to patent professionals to avoid conflation of the § 101 subject matter eligibility inquiry with § 102 and § 103 novelty and obviousness considerations.

We have previously reported that the cost to develop a new drug is roughly $2.7B (inflation adjusted).  This price tag was determined by the Tufts Center for the Study of Drug Development (CSDD).  However, a new study published in JAMA Internal Medicine calls this number into question.  The disparity in drug development cost estimates between the CSDD and other groups prompted the JAMA authors to conduct their own study.  For instance, the independent group Public Citizen estimated the cost to be around $320M (inflation adjusted).  Unlike other estimates, the JAMA study places the cost of developing a new cancer drug to be around $648M.  The authors go into further detail to compare and contrast the metrics and methods by which other groups have calculated drug costs.  Whereas the CSDD study used private information from ten large pharmaceutical companies, the Public Citizen study used publicly available Securities and Exchange Commission filings.  Both analyses looked at companies with multiple drugs on the market.  However, the JAMA study focused on ten companies that each only developed a single drug, which, the authors argue, yields a more “transparent” analysis.