News & Analysis as of

Patents Pharmaceutical Patents

Wilson Sonsini Goodrich & Rosati

Inventor’s Failure to Provide Material Information to the USPTO Results in an Unenforceable Patent

On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

Jones Day on

Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Smart & Biggar

Federal Court of Appeal confirms generic not required to address patent submitted before ANDS filing but listed after

Smart & Biggar on

On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to Health Canada was...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation USA - October 14th - 15th, New York, NY

Attend ACI's inaugural Forum on Pharma & Biotech Patent Litigation USA and garner a winning edge in the high- stakes life sciences patent ligation arena. Get the in-depth and practical information that you need to develop...more

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Goodwin

UK Court of Appeal Upholds Moderna mRNA Patent Against Pfizer/BioNTech

Goodwin on

On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

Knobbe Martens on

The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Venable LLP

Spotlight On: Biosimilar Litigations - August 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

A&O Shearman on

After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

Wolf, Greenfield & Sacks, P.C.

Strategic Uses and Considerations for Reissue Applications (Part 2 of 3)

Reissue applications represent a very small fraction of the total number of applications filed at the USPTO each year. Indeed, at the midpoint of 2025, over 1.2 million utility applications have been filed, with less than 300...more

Hudnell Law Group

Federal Circuit Rejects Formalistic Shield to Prosecution History Estoppel

Hudnell Law Group on

On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more

Womble Bond Dickinson

Reminder: “Consisting essentially of” Is U.S. Patent Claim Language Needing Interpretation

Womble Bond Dickinson on

On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...more

Venable LLP

PTAB Director Discretionarily Denies Opdivo® IPRs Based on Settled Expectations of Patent Owner

Venable LLP on

On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more

Rothwell, Figg, Ernst & Manbeck, P.C.

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

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

Goodwin

Fresenius Files Two IPRs Against Regeneron Aflibercept Patents

Goodwin on

On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more

Robins Kaplan LLP

Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use...more

Venable LLP

Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23

Venable LLP on

On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23...more

Knobbe Martens

Combination Dosing Regimen Not Obvious Despite Overlapping Prior-Art Ranges

Knobbe Martens on

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more

Alston & Bird

Patent Case Summaries | Week Ending July 18, 2025

Alston & Bird on

Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., et al., Nos. 2023-1864, -1940 (Fed. Cir. (PTAB) July 14, 2025). Opinion by Dyk, joined by Lourie and Cunningham....more

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

A&O Shearman

Overlapping Range Presumption Not Applied Given Specified Doses Administered At Specified Times

A&O Shearman on

On July 8, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the validity of a Janssen patent, finding that Teva did not meet its burden to prove obviousness. In so doing, the Federal Circuit provided...more

McDermott Will & Schulte

Motivation, expectation of success negate obviousness presumption in overlapping range case

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

Carlton Fields on

In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

Jones Day on

In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Mintz - Intellectual Property Viewpoints

Is Your Enantiomer Possessed? Patenting of Enantiomers – Does Written Description Require More Than Actual Possession?

It is well established that an enantiomerically pure compound exhibiting advantageous properties not present in its isomer or its corresponding racemic mixture, can be patented even if its corresponding racemic mixtures are...more

3,414 Results
 / 
View per page
Page: of 137

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide