On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more
On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making....more
The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more
2/5/2024
/ Bayh-Dole Act ,
Biden Administration ,
Comment Period ,
Competition ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Inventions ,
March-in-Rights ,
NIST ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Comment
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more
12/5/2023
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 5
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more
In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of...more
4/1/2019
/ Appeals ,
Claim Construction ,
Judgment on the Pleadings ,
Method Claims ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Product of Nature Doctrine ,
Remand ,
Reversal ,
Section 101
Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more
7/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Amended Regulation ,
Biosimilars ,
BPCIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Generic Drugs ,
Hatch-Waxman ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation ,
USPTO
Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its...more
4/30/2018
/ Agricultural Sector ,
Bayer ,
Biotechnology ,
Department of Justice (DOJ) ,
EU ,
Farms ,
Genetically Engineered Seed ,
Life Sciences ,
Mergers ,
Monsanto ,
Pharmaceutical Industry
On January 31, two Seattle biotech companies, Seattle Genetics and Cascadian Therapeutics, announced a merger agreement under which Seattle Genetics will acquire Cascadian Therapeutics for $614 million. The announcement...more
A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more
The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more
On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more
Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more
7/1/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
Good Faith ,
Janssen Pharmaceuticals ,
Lost Profits ,
Negotiations ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approval...more
On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more
On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of...more
Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more
Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries. Such a decision may have long-term business and legal consequences. ...more
On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written...more
10/10/2016
/ Anticipation ,
Appeals ,
Board of Patent Appeals ,
Inherent Disclosure Doctrine ,
Patent Applications ,
Patent Litigation ,
Patents ,
Prior Art ,
Priority Date Cutoff ,
Priority Patent Claims ,
Remand ,
Summary Judgment ,
Written Descriptions
In This Presentation:
• Patent infringement suits
– Costly
– Risk of preliminary injunction
– Time consuming
– Risk of customers being sued
– Damages
• Lost profit or reasonable royalty
• Treble...more