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Category: Recent News & Articles

The Emergent Microbiome: A Revolution for the Life Sciences – Part XIV, Revisiting Immunotherapy and Combination Therapies

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.

Court Begins Year with Consistent 101 Decisions, But Then Adds Confusion

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– the precedential Finjan vs Blue Coat, Core Wireless vs LG electronics, and Berkheimer vs HP Inc. decisions and the non-precedential Move Inc. vs Real Estate Alliance decision.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 of Dilworth IP Quoted in Law 360

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.”

U.S. Tops Leaderboard on Chamber of Commerce 2018 IP Index – Slips to #13 in Patent Protection

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.

Nanomedicine: A Vast Horizon on a Molecular Landscape – Part XI, Cosmeceuticals

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.

FDA Orange Book – Patent Procedural Update

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.

Be Specific: Further Thoughts from Two-Way Media to Avoid a 101 Misstep

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.

Does It Still Cost $2.7B to Develop a Drug? Regardless, Patent Protection is Key!

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.

Updates from the USPTO on Subject Matter Eligibility

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 & Dr. Anthony Sabatelli Featured in the IP Litigator

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.