Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to...more
On November 30, 2021, a jury in the patent infringement suits between Illumina, Inc. and BGI Genomics Co. in the U.S. District Court for the Northern District of California returned a verdict invalidating certain patent...more
The Federal Circuit recently issued a split panel decision on induced infringement. The court's decision is important in that it may, if upheld upon further appeal and not distinguished by subsequent courts, limit the ability...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
8/25/2020
/ Appeals ,
FDA Approval ,
Life Sciences ,
Marketing Exclusivity Periods ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reaffirmation ,
Treatment Method Patents
The Federal Circuit, in Illumina, Inc., v. Ariosia, reversed the summary judgment decision of a lower trial court and upheld—as patent subject matter eligible—claims in two patents (U.S. 9,580,751; U.S. 9,738,931). The...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
2/12/2020
/ CGMP ,
Consent Decrees ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Compounding ,
Due Diligence ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Patent Infringement ,
Product Recalls
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
On May 30, 2017, in Impression Products, Inc. v. Lexmark International, Inc., the U.S. Supreme Court held that a domestic or foreign sale of a patented product exhausts all U.S. patent rights in that product. The case was...more
In This Issue:
- The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities
- Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers
- Life...more
6/24/2015
/ Department of Justice (DOJ) ,
Diagnostic Tests ,
Emerging Growth Companies ,
Enforcement Actions ,
Equity Financing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Human Genome Project ,
Initial Public Offering (IPO) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Myriad ,
Patent Infringement ,
Patents ,
Personalized Medicine ,
Venture Capital