Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the...more
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more
Rumor has it that one of many behind-the-scenes changes being implemented at the USPTO relates to how (or when) continuing applications are taken up for examination. Typically, an examiner may give priority to a continuing...more
Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications....more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
1/21/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
The USPTO has published its final rule setting patent fees that will take effect January 19, 2025. The final rule steps back from some of the new fee structures proposed in April 2024, but still could have a significant...more
The U.S. Patent and Trademark Office (USPTO) has announced that its “After Final Consideration Pilot Program 2.0” (“AFCP 2.0”) will come to an end on December 14, 2024. First rolled out in 2013, the program was part of USPTO...more
The U.S. Patent and Trademark Office (USPTO) has revealed “a coding error” in the software used to calculate Patent Term Adjustment (PTA) awards that may have impacted patents issued from March 19, 2024, through July 30,...more
I have been waiting for developments on the Patent Eligibility Restoration Act (PERA) since I testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee in January 2024, and in the meantime...more
Companies in the food and beverage industry might overlook significant advantages by not patenting their innovations. While there’s a common belief that “recipes” cannot be patented, unique formulations and other aspects of...more
In its most recent decision addressing the complicated interplay between Patent Term Adjustment (PTA) and obviousness-type double patenting (OTDP), the Federal Circuit ruled that a first-filed, first-issued parent patent...more
The U.S. Patent and Trademark Office’s (USPTO’s) proposed rulemaking that focuses on “fee adjustments” for 2025 includes a trap for the unwary related to Information Disclosure Statements (IDSs) that could complicate...more
In a stunning Federal Register Notice published May 10, 2024, the U.S. Patent and Trademark Office (USPTO) proposes to impose a new requirement on terminal disclaimers filed to overcome obviousness-type double patenting...more
For the first time in nearly 15 years, the U.S. Patent and Trademark Office (USPTO) has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int’l Co. v....more
4/23/2024
/ America Invents Act ,
Decision-Making Process ,
Ex Partes Reexamination ,
Graham Factors ,
Guidance Update ,
Inventions ,
New Guidance ,
Obviousness ,
Patent Applications ,
Patent Examinations ,
Prior Art ,
USPTO
The USPTO has taken another step towards implementing fee adjustments in January 2025, by publishing a Notice of Proposed Rulemaking (RPRM) on April 3, 2024.. The NPRM stands by most of the significant fee adjustments it...more
The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more
If the U.S. Patent and Trademark Office (USPTO) is going to implement fee changes in January 2025, we should see a Federal Register Notice detailing the proposed fees soon. The USPTO started this round of fee-setting in April...more
2/20/2024
/ Filing Fees ,
Information Disclosure Statement ,
Inventors ,
Notice of Proposed Rulemaking (NOPR) ,
Patent Applications ,
Patent Public Advisory Committee (PPAC) ,
Patent Term Adjustment ,
Patent Term Extensions ,
Priority Patent Claims ,
Proposed Legislation ,
Request for Continued Examination ,
Small Business ,
Terminal Disclaimer ,
USPTO
The U.S. Patent and Trademark Office (USPTO) has released new training materials on “Declaration practice under 37 CFR 1.132 (Rule 132).” The materials were developed under a collaboration initiative with the U.S. Food and...more
When we first wrote about the Patent Eligibility Restoration Act (PERA), I had no idea I would have the honor of being invited to testify before the Subcommittee on Intellectual Property of the Senate Judiciary Committee, but...more
The USPTO has issued “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.” The Guidelines set forth the U.S. Patent and Trademark...more
When Dynamic Drinkware was decided in 2015, commentators debated whether differences in the language of the American Invents Act (AIA) version of 35 USC § 102 would shield AIA patents from its restrictions. Now, U.S. Patent...more
Share on Twitter Print Share Back to top The Patent Term Extension (PTE) provisions of 35 U.S.C. 256 were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. PTE partially compensates...more
The Supreme Court recently declined to review Personalized Media Communications, LLC v. Apple Inc., where a divided panel of the Federal Circuit upheld the district court’s finding that a PMC patent is unenforceable due to...more
As announced in a September 14, 2023, press release, the FTC has issued a policy statement “warning pharmaceutical companies that make and sell brand-name drugs that they could face legal action if they improperly list...more
In In re Cellect, the Federal Circuit effectively held that Patent Term Adjustment (PTA) awarded under 35 USC § 154 is not protected from obviousness-type double patenting (OTDP) in view of a patent with the same 20-year...more