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Prior Art Patent Validity Pharmaceutical Patents

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Fish & Richardson

Can Clinical Trials Negate Patentability for Pharma Inventions?

Fish & Richardson on

The answer to this inquiry is “yes” — but maybe “no.” Will confidentiality agreements shield any prior art concerns? Once again, maybe “yes” — but maybe “no.” Indeed, do clinical trials constitute an experimental use that...more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Miller Canfield

Jepson Claims No Substitute for Written Description in Patents

Miller Canfield on

Federal Circuit Holds That the Preamble of Jepson-Style Claims Must Be Supported by an Adequate Written Description - U.S. patent claims have a preamble, and, in most cases, the preamble is not limiting. Jepson-style...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Vorys, Sater, Seymour and Pease LLP

The Precedent: Federal Circuit Provides Further Clarity on Issues Surrounding Patent Validity in Novartis Pharmaceuticals Corp. v....

In this edition of The Precedent, we outline the validity of a pharmaceutical patent concerning the patent’s written description. Following an appeal from the United States District Court for the District of Delaware, the...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) - January 2025

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

Smart & Biggar

Federal Court reinstates decision that REMICADE new use patent is valid and infringed

Smart & Biggar on

Update: The litigation between Janssen and Hospira relating to the biosimilar INFLECTRA, including the appeal of the reconsideration decision, was discontinued in July 2021. As reported previously... the Federal Court had...more

Knobbe Martens

Non-Prior Art Evidence May Be Used to Prove Inherency

Knobbe Martens on

HOSPIRA, INC. V. FRESENIUS KABI USA, LLC - Before Lourie, Dyk, and Moore.  Appeal from the U.S. District Court for the Northern District of Illinois. Summary:  Evidence of the properties of claimed embodiments may be...more

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

Smart & Biggar

Year-end Round-up: Notable Canadian Patent Cases of 2018

Smart & Biggar on

Earlier this month we published an exhaustive review of the life sciences and regulatory cases in the Canadian courts, and decisions on the merits for the year are summarized in our in our Rx IP Update 2018 Highlights in...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights - January 2019: PTAB Only Partially Smokes Cannabis Patent

Eleven of thirteen cannabis patent claims survive PTAB challenge. Insys Development Company, Inc. filed a petition requesting inter partes review of claims 1-13 of GW Pharmaceutical Ltd.’s patent directed to the use of...more

Knobbe Martens

Impax Laboratories Inc. v. Lannett Holdings Inc.

Knobbe Martens on

Federal Circuit Summaries - Before Lourie, Dyk, and Taranto. Appeal from the District Court for the District of Delaware. Summary: A passing reference in the prior art to a formulation containing the claimed active...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Merck v. Hospira, the only precedential case decided this week, a majority of the panel affirms a determination of obviousness, noting that despite the objective indicia supporting patentability, the claimed process was...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

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