On December 27, 2023, Chief Judge Catherine Eagles of the U.S. District Court for the Middle District of North Carolina granted a motion for preliminary injunction by Natera Inc. enjoining NeoGenomics Laboratories Inc. from...more
You’ve finished drafting the patent application for a critical, clinical stage invention. The scientific team wrote up the examples and they even included comparative data. You’ve finalized the claims and specification....more
In a case relating to use of recombinant human interferon-ß (IFN-ß) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” analysis applies even when...more
Scientists, clinicians, and other investigators are discovering new uses for drugs previously known for different medical indications. Such “drug repurposing” (also called drug repositioning, profiling, or re-tasking) has...more
Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more
Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
Federal Circuit Hands Down Modified Opinion in Illumina, Inc. v. Ariosa Diagnostics, Inc. Earlier this year, the Federal Circuit (somewhat surprisingly) found claims of two Sequenom patents directed to methods for...more
Preparing and prosecuting medical device patents can be unique and challenging. Patent owners and practitioners often must consider a wide range of converging technologies from the mechanical, electrical, chemical, and...more
In a conundrum worthy of a law school civil procedure examination, plaintiff Gensetix found itself apparently with no remedy for infringement by Baylor College of Medicine, Diakonos Research Ltd., and William Decker of...more
A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more
Spanning 5525 miles, the United States-Canada border is the longest border between any two countries. U.S. goods and services trade with Canada totaled an estimated $718.5 billion in 2018, possibly the largest bilateral trade...more
It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. §...more
The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more
Case Summary- On March 17, 2020, the Federal Circuit found that patents claiming methods of preparing an extracellular fraction of cell-free DNA that is enriched in fetal DNA were patent eligible and not invalid under 35...more
On May 15, 2020, Manson J. of the Federal Court dismissed two actions brought by Biogen under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) alleging infringement of Patent No. 2,562,277 (277...more
Despite evidence that defendants monitored plaintiffs’ product development and attempted to match its dosing intervals, the District Court of Delaware found no willful infringement because that activity took place before the...more
Last month, in Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit reversed a decision by the U.S. District Court for the District of New Jersey finding certain claims of U.S. Patent...more
In his (perhaps, what will one day be a) seminal report on the results of a clinical trial, Dr. Didier Raoult and colleagues reported that after six days of administering hydroxychloroquine combined with azithromycin, 100% of...more
The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) claim construction (and inter partes review (IPR) decision invalidating claims for obviousness) in it recent Genentech, Inc. v. Iancu decision, and also...more
The US Court of Appeals for the Federal Circuit reversed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding the decision was infected by an erroneous claim construction that failed to consider the purpose of...more
Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome...more
This month, the U.S. Court of Appeals for the Federal Circuit has handed down a pair of opinions concerning Section 101 in the field of pharmaceuticals and life sciences. In both cases, the district courts held claims of the...more
Mallinckrodt filed a certiorari petition with the Supreme Court last week, over the Federal Circuit panel decision (by Chief Judge Prost joined by Judge Dyk; Judge Newman dissented on the issue before the Court in this...more
The Federal Circuit recently held certain method of treatment claims patent eligible under step one of Alice, reversing a district court’s judgment on the pleadings. In that same case, the Federal Circuit upheld the district...more
Update: On January 8, 2021, the Supreme Court of Canada dismissed Janssen’s application for leave to appeal (Docket No. 39099). On January 12, 2021, the Trial Judge issued the reconsideration decision, again finding the...more