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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.

On January 4th, the U.S. Patent and Trademark Office updated their webpage on subject matter eligibility with two new supplementary documents providing further guidance under 35 U.S.C. §101. The two new documents are useful summaries and references for practitioners and others having an interest in the area. The two documents, which are briefly described below are:

Dilworth IP’s David Puleo and Dr. Anthony Sabatelli recently had an article featured in the bi-monthly publication IP Litigator. Their article, entitled “UK Supreme Court Redefines Patent Infringement,” considers the United Kingdom Supreme Court decision in Actavis UK Limited and others v. Eli Lilly and Company, and the implications it has on defining patent infringement.

Dilworth IP was a proud sponsor of the 2nd Annual China Pharma Intellectual Property Summit. Dilworth IP’s Michael Dilworth, Anthony Sabatelli and Jing Zhou attended the event, which was held in Shanghai on December 7th and 8th. The summit is an opportunity for in-house counsel members from Chinese pharmaceutical companies to network with intellectual property attorneys from around the world. With laws concerning the pharmaceutical industry continuing to evolve in China, the summit becomes increasingly more important.

Dilworth IP proudly participated in the Salvation Army’s Angel Tree Program this Holiday Season. Every Year, the Salvation Army finds children who would otherwise not receive any gifts on Christmas morning, and matches them to donors who are provided with tags that have an individual child’s wish list on them. The donor then returns the tag to the Salvation Army with the gifts they purchased. Ann Marie Poremba, Head of Dilworth IP’s Culture and Community Committee coordinated the Firm’s participation with the Salvation Army’s Major Kathi Longcoy. “I am very proud of our team’s participation in the Angel Tree Program; we had an outpouring of gifts coming in everyday;” Michael Dilworth, Founder and Managing Partner at Dilworth IP said, “it is important to me, and to our culture here, to support those who are less fortunate than we are, especially during the Holiday Season.”

Clarity on patent subject matter eligibility is still being sought five years after Mayo[1] and three years after Alice[2]. Further adding to the confusion is the fact that discoveries in diagnostics, despite their apparent importance to the biomedical sciences, have been repeatedly determined as ineligible subject matter under 35 USC § 101. The two step Alice/Mayo test has increased the percentage of invalid patents, and the decision by the Supreme Court to deny certiorari in the case of Ariosa vs. Sequenom[3] in 2016 means we are unlikely to see a reversal of this trend in the near future. Inventors are still finding it challenging to implement the current guidelines toward a successful diagnostics patent grant.  In this piece we provide perspective from a 2016 Federal Circuit decision that provides some over-looked hints for moving forward with inventions relating to diagnostics.