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
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
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
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
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
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
In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more
On April 26, 2023, Senator Elizabeth Warren and Congresswoman Pramila Jayapal sent a letter to USPTO Director Kathi Vidal complaining about the USPTO’s failure “to address the pharmaceutical industry’s abuse of the patent...more
The USPTO has commenced the fee-setting process for fee adjustments it expects to implement in January 2025. While many fee changes are modest (~5%), the USPTO proposes significant increases to design patent fees and PTAB...more
The USPTO will transition from officially issuing patents in paper form to officially issuing patents electronically, starting April 18, 2023. In addition to saving paper, the USPTO predicts the change to electronically...more
It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more
The USPTO has issued a Federal Register Notice soliciting comments on “proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while...more
In Sawstop Holding LLC v. Vidal, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute that limits the availability of PTA for time spent appealing an Examiner’s rejection. The...more
The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more
The USPTO Patent Term Adjustment (PTA) rules include a “safe harbor” that avoids a PTA deduction for “Applicant delay” for Information Disclosure Statements that are accompanied by a certain statement averring that the items...more
After being closed for more than two years due to the Covid-19 pandemic, the USPTO has opened all locations to employees and resumed some public in-person events. That said, PTAB hearings and TTAB hearings are still being...more
Without naming names or technology, I wanted to share an interesting rationale for obviousness I came across recently. The rejection was an “obvious to try” type rejection, based on the assertion that it would have been...more