The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025)....more
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
7/24/2025
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the...more
Although the Corporate Transparency Act (the “CTA”) is no longer halted by nationwide preliminary injunctions, U.S. companies and their beneficial owners are not required to report beneficial ownership information pursuant to...more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
3/20/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
USPTO
In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA...more
For the past few months, the beneficial ownership reporting obligations under the Corporate Transparency Act (the “CTA”) have fluctuated between being required pursuant to the CTA and being halted by nationwide preliminary...more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
2/19/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Clinical Trials ,
Competition ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Intellectual Property Protection ,
Medicare ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
1/14/2025
/ Biosimilars ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Approval ,
Regulatory Requirements
Only days after lifting the nationwide preliminary injunction, the Fifth Circuit Court of Appeals vacated their decision to stay the district court’s preliminary injunction enjoining enforcement of the Corporate Transparency...more
Since the America Invents Act (“AIA”) established a new venue for hearing patent disputes, the Patent Trial and Appeal Board (“PTAB”), much ink has been spilled regarding the impacts of this forum on patent litigation and the...more
12/27/2024
/ America Invents Act ,
Article III ,
Burden of Proof ,
Declaratory Judgments ,
Fees ,
Filing Deadlines ,
Innovation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Small Business ,
Standing ,
Transparency ,
USPTO
As an update to our posts on the ongoing attempts to block the Corporate Transparency Act, on December 23, 2024, the Fifth Circuit granted a temporary stay of the district court’s preliminary injunction for compliance with...more
12/27/2024
/ Appeals ,
Beneficial Owner ,
Business Entities ,
Corporate Transparency Act ,
Filing Deadlines ,
Filing Requirements ,
FinCEN ,
Preliminary Injunctions ,
Reporting Requirements ,
Stays ,
Time Extensions
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
12/23/2024
/ Abbreviated New Drug Application (ANDA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Listing Rules ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Statutory Interpretation ,
Teva Pharmaceuticals
The United States Patent and Trademark Office (USPTO) announced today the finalized fee increases taking effect on January 19, 2025. While applicants can still expect significant increases in certain areas, some proposed fee...more
11/20/2024
/ Applications ,
Corporate Counsel ,
Disclaimers ,
Duty to Disclose ,
Fees ,
Information Disclosure Statement ,
Patent Applications ,
Patent Ownership ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patentability Search ,
Patents ,
USPTO
The Corporate Transparency Act (CTA) went into effect on January 1, 2024, and will impact millions of U.S. businesses by imposing requirements to file corporate transparency reports with beneficial ownership information...more
Following the U.S. Supreme Court’s invalidation of a counterpart U.S. patent in the same family for lack of enablement (21-757 Amgen Inc. v. Sanofi (05/18/23) (supremecourt.gov)), the UPC has now rendered a decision on its...more
Heading into 2025, patent applicants should prepare for significant fee increases at the United States Patent and Trademark Office (USPTO). These fee increases can significantly impact patent applicant behavior, leading...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...more
After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more
Federal funding is a huge boon for companies, universities, and research institutions conducting innovative research. However, it comes attached with requirements that can become a stumbling block, especially for emerging and...more
3/6/2023
/ Bayh-Dole Act ,
Contractors ,
Emerging Technology Companies ,
Federal Funding ,
Filing Requirements ,
Innovation ,
Innovative Technology ,
Intellectual Property Protection ,
Inventions ,
Patent Ownership ,
Reporting Requirements ,
Research and Development
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
3/1/2023
/ Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Interchangeability ,
Marketing ,
Patients ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation ,
USPTO
Gene therapies have been the subject of tremendous scientific research and investment. With hundreds of clinical trials in progress and many target applications, the biotechnology, agricultural, and pharmaceutical fields are...more