Category: News

Rising Temperatures – Federal Circuit Warming to Patent Eligibility of Medical Diagnostics

For the first time since the Mayo Supreme Court decision of 2012, the Court of Appeals for the Federal Circuit (CAFC) in Exergen vs Kaz has ruled in favor of the patent eligibility of a medical diagnostic invention.  While nonprecedential, this 2-to-1 decision is noteworthy for the guidance it provides to patent professionals seeking to protect diagnostic inventions.  Specifically, it instructs that diagnostic methods may be eligible for patent coverage so long as they use unconventional methods for detecting analytes.  Additionally, the Exergen decision offers another endorsement of the view put forth recently by the CAFC in Berkheimer v. HP and Aatrix v. Green Shades, that the inventive concept analysis that can arise in step-2 of the Mayo/Alice test is at least in part a factual question and not just a question of law.  This factual vs legal debate continues to have reverberations throughout the patent law field, affecting both the manner in which courts conduct 101 examinations as well as the conclusions they reach.

Upcoming Free Webinar: Just What is the Federal Circuit Thinking?

Dr. Anthony Sabatelli & David Puleo will be presenting a free webinar on Thursday, April 19th at 1:00 PM (ET) for Dilworth IP, entitled, “Just What is the Federal Circuit Thinking? A Path Forward Amid Subject Matter Eligibility Variability.” Tens of millions spent on product development – how do you protect your company’s technology in an environment where the Federal Circuit redefines patent eligible subject matter on nearly a weekly basis, and where the USPTO’s application of these judgments is just as inconsistent? Is subject matter eligibility no longer a question of law and is it now morphing into a question of fact?

Local Company Brings National Distributor to Local Court On Trademark Infringement Claim

The U.S. District Court of Connecticut has ruled that a small Connecticut manufacturing company can sue an Indiana- based national manufacturer and wholesaler for trademark infringement in Connecticut, based on the defendant’s modest sales to distributors in Connecticut.  This illustrates how Connecticut courts provide an important forum for Connecticut business to protect their brands against out-of-state competitors that sell into Connecticut.

Matthew Siegal of Dilworth IP Published in The Intellectual Property Strategist

Matthew Siegal, a patent attorney with Dilworth IP’s affiliate firm, Dilworth & Barrese, and Of Counsel to Dilworth IP, recently had an article published in The Intellectual Property Strategist entitled, “Even the Value of the Smallest Salable Unit Must Bes Apportioned.” In the article, Mr. Siegal discusses the Federal Circuit ruling in Finjan, Inc. v. Blue Coat.

The I-O Movement:  Priming the Immune System to Fight Cancer – Part I:  Chimeric Antigen Receptor T (CAR-T) Cell Technology

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.

Protecting Pharmaceuticals at the Intersection of Patent and Regulatory Law

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.

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.