Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
End of an Era: The After Final Consideration Pilot Program 2.0 Concludes
The sun is officially setting on the United States Patent and Trademark Office’s (USPTO) After Final Consideration Pilot Program 2.0 (AFCP 2.0)[1]. This program, which has been instrumental in facilitating...
Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in...
CDRH Announces Pilot Program to Improve Recall Communication
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for...
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial intelligence...
Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson[1], the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal...
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
Nobel Prize in Medicine Awarded to American Scientists for Discovery of microRNA
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of microRNA, a new class of small noncoding RNA molecules, and the role microRNAs play in turning genes on and off, known as gene regulation.
FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease (Cgvhd)
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from Syndax Pharmaceuticals), for treatment of chronic graft-versus-host disease (cGvHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Science Group Sues FDA Over New Laboratory-Developed Test Rule
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, explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA. The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule.
Novartis Loses Bid for Preliminary Injunction Against MSN Pharmaceuticals
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456 (D. Del. Aug. 12, 2024). Novartis had requested a preliminary injunction to block MSN Pharmaceuticals from launching a generic version of Novartis’s top-selling oral heart failure drug Entresto®.
Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological products. The bill attempts to target “patent thickets” or the large patent portfolios companies create with significantly overlapping patent rights seen by lawmakers as obstacles to competitors entering the market.
Allergan v. MSN Laboratories: Federal Circuit Places Limits on Obviousness-Type Double Patenting
On August 13, 2024, the Federal Circuit issued its decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the scope of obviousness-type double patenting for patents in the same family. The Federal Circuit held that a first-filed, first-issued, later-expiring patent claim cannot be invalidated for obvious-type double patenting based on a later-filed, later-issued, earlier-expiring child patent when the patents share a common priority date.
Understanding the Dangers of Counterfeit Drugs Through the Lens of Fake Ozempic
The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017 for the treatment of type 2 diabetes. A few years later, clinical trials demonstrated that Ozempic® could also be used for weight loss in individuals without diabetes who had previously struggled to lose weight. News of the “miraculous weight loss” achieved with Ozempic® (and its sister drug Wegovy®) led to widespread demand for the drug and global shortages.
“Improper” Listing of Patents in the FDA’s Orange Book
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book” or “OB”).
WIPO Member States Adopt New Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
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. Genetic resources, which can include medicinal plants, agriculture crops and animal breeds, cannot themselves be claimed as intellectual property. However, inventions developed using genetic resources can be protected, usually through patents. The stated goals of the treaty include enhancing the efficacy, transparency, and quality of the patent system and preventing patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge.
Branded Manufacturers Decline to Remove Patents From the Orange Book After Receiving Letters From the FTC
On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to their patent listings in the FDA’s catalog in view of the warning letters.
FDA Panel Votes Against MDMA-Assisted Talk Therapy
On June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder (PTSD) voted 9-2 that MDMA in combination with talk therapy is not effective for treating PTSD, and 10-1 that the benefits of MDMA treatment do not outweigh its risks. The panel had reviewed Lykos Therapeutics ’s new drug application and associated clinical research related to treating PTSD using MDMA, also known by its street name ecstasy, in combination with talk therapy.
FDA Issues Final Rule on Laboratory-Developed Tests
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are within the purview of the FDA.[2] The final rule will publish on May 6, 2024.[3] Until then, the unpublished version is available. [4]
Medicare Drug Price Negotiation Program Steadily Progressing Despite Lawsuits
The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges.
USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources
On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. The new training materials were presented to the public at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, held in person at the USPTO headquarters in Alexandria, Virginia, and at the USPTO Silicon Valley Regional Office in San Jose, California, on March 19, 2020.