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
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
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
The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the...more
In a bulletin issued July 24, 2022, focused on Director Review of Patent Trial and Appeal Board (PTAB) decisions in AIA trials, the USPTO also announced the creation of “a new Appeals Review Panel (ARP), which may be convened...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
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
The USPTO first established a pro bono program to help “financially under-resourced inventors and small businesses” pursue patent protection for their inventions under the America Invents Act (AIA). The USPTO recently...more
In Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board decision upholding Teva’s patents directed to specific methods of treatment using an...more
As much of the United States is taking steps towards “getting back to normal,” the USPTO continues to implement programs to encourage investment and innovation in technologies addressing the COVID-19 pandemic. Recently, the...more
Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA practices, but adds a new...more
The USPTO has issued a request for comments on proposed changes to requirements for admission to the patent bar. Last week I had an opportunity to speak with Commissioner for Patents Drew Hirshfeld, who currently is...more
The USPTO has published proposed guidelines on the types of courses and activities that will qualify for USPTO CLE credit, which practitioners may voluntarily report in the mandatory biennial registration statements that will...more
In Nike, Inc. v. Adidas, AG, the Federal Circuit held in the context of an Inter Partes Review proceeding that “[i]f the Board sua sponte identifies a patentability issue for a proposed substitute claim … it must provide...more
In Liqwd, Inc. v. L’Oreal USA, Inc., the Federal Circuit vacated a decision of the USPTO Patent Trial and Appeal Board (PTAB) that failed to take into account evidence of copying in its obviousness analysis. The Federal...more
In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more
10/17/2019
/ Apotex ,
Clinical Trials ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Reasonable Expectations Test ,
Reversal
On Friday I will be speaking at the AUTM Eastern Regional Meeting, on a panel discussing patent eligibility issues for life sciences inventions. My topic relates to what the USPTO refers to as “nature-based products,” but...more
The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads, and highlights that it’s rarely possible to...more
Provisional applications tempt stakeholders with the possibility of securing a filing date on an expedited basis and limited budget, but the value of that filing date will depend on its ability to serve as a valid priority...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast...more
2/26/2019
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Article III ,
Bristol-Myers Squibb ,
Inter Partes Review (IPR) Proceeding ,
Momenta ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more
Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more
1/23/2019
/ Abbreviated New Drug Application (ANDA) ,
Article III ,
FDA Approval ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more