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
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
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
It is hard to predict whether a given bill will gain traction, but when the Senate Judiciary Committee reports out five bipartisan bills targeting pharmaceutical patents and pricing, it seems likely they are determined to get...more
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...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 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
The Federal Circuit decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., is getting attention for potentially “endangering” the practice of skinny labelling. Indeed, the Federal Circuit held that Teva’s skinny...more
In Biogen International GmbH v. Banner Life Sciences LLC, the Federal Circuit construed language of the Hatch-Waxman patent term extension statute in a manner Biogen argued was inconsistent with the “active moiety” focus of...more
The Federal Circuit decision in HZNP Medicines LLC v. Horizon Pharma USA, Inc. is a good reminder that even standard “patent lingo” can cause trouble down the line. Now that the court has denied rehearing en banc (with Judges...more
As set forth in this March 2, 2020 Federal Register Notice and effective immediately, the USPTO is going to start inquiring into petitions to revive an abandoned application, accept a delayed maintenance fee payment, or...more
The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for...more
Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more
1/10/2020
/ Alice Corporation ,
Amicus Briefs ,
Bilski ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Personalized Medicine ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Solicitor General ,
Split of Authority
We previously discussed the new personalized medicine example in the USPTO’s October 2019 Patent Eligibility Guidance Update. Here, we look at the new nature-based product example, and consider how it may impact...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
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more
In contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement, the Federal Circuit decision in...more
Recent Federal Circuit decisions demonstrate that the doctrine of equivalents is alive and well, and not always barred by claim amendments. In both Ajinomoto Co. v. ITC and Eli Lilly and Co. v. Hospira, Inc., the Federal...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
The “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019” would create a presumption that every other patent listed in the Orange Book has been terminally disclaimed over the earliest-expiring Orange...more
Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more
6/12/2019
/ American Civil Liberties Union (ACLU) ,
Biosimilars ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Expert Testimony ,
Expert Witness ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Reform ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
In Nuvo Pharmaceuticals, In. v. Dr. Reddy’s Laboratories Inc., the Federal Circuit reversed the district court and found the asserted patents invalid for failing to satisfy the written description requirement. This decision...more
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more
4/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Alice Corporation ,
Appeals ,
Endo Pharmaceuticals ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Teva Pharmaceuticals ,
USPTO
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