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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.

In Two-Way Media Ltd. v. Comcast Cable Communications, LLC, the Federal Circuit affirmed the decision of the District Court of Delaware that the Two-Way Media patents and claims were ineligible under 35 U.S.C. § 101.  See the Federal Circuit decision here.  Two-Way sued Comcast, alleging that Comcast violated U.S. Patent Nos. 5,778,187 (‘187); 5,983,005 (‘005); 6,434,622 (‘622); and 7,266,686 (‘686) relating to a “Multicasting method and apparatus”.  These patents are directed to a “scalable architecture … or delivery of real-time information over a communications network”.  This essentially refers to methods for streaming data over the internet to multiple users at a time.  The outcome of this case teaches important lessons on how and where to define inventive concept under the two-part Mayo/Alice test.

On September 11, 2017, the two parties involved in Naruto v. Slater – publicly known as “the Monkey Selfie” – jointly asked the U.S. Court of Appeals for the Ninth Circuit to dismiss their appeal, and nullify the judgment already made by the lower court. This case has been frequently reported and discussed by both the popular press and serious legal sources, because it unearths our fundamental human assumptions that animals lack a level of awareness to take self-portraits of themselves, let alone raises a copyright question.

On October 18, the CAFC Circuit Court delivered a verdict in Smart Sys. Innov. v Chicago Trans. Auth. that adds an interesting new wrinkle for determining the question of patent subject matter eligibility.  In a split decision, the court ruled that several contested patents held by SSI were directed to an abstract idea following the Mayo/Alice test for determining patent eligibility, and were therefore invalid.  The dissenting opinion, penned by Judge Linn, offered an interesting, and in our opinion, reasonable, new interpretation for the Mayo/Alice test for determining patent eligibility.

We are fast approaching the Supreme Court oral arguments in the case of Oil States Energy Services LLC v. Greene’s Energy group on Monday, November 27th. We had previously reported on this case in a recent piece, Oil Battles Greene Energy to War over Inter Partes Review in the Supreme Court.  A whopping 57 amicus curiae briefs have been filed, underscoring the intense interest in the outcome of this case.  The briefs represent a vast array of interested parties, including law professors, legal associations, small businesses, and recognized companies in the fields of medicine, electronics, automobiles, and technology. The key issue of the case is simple – whether the Patent Office’s inter partes review (IPR) process is an unconstitutional denial of the right to a jury trial.