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United States Patent and Trademark Office › Patent Invalidity › Pharmaceutical Industry

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Venable LLP

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

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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

Womble Bond Dickinson

2024 Hatch-Waxman Year in Review

Womble Bond Dickinson on

In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...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

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

American Conference Institute (ACI) on

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Anacor Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2018)

McDonnell Boehnen Hulbert & Berghoff LLP on

On Monday, May 14, 2018, the Federal Circuit affirmed the determination by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board in an inter partes review that claim 6 of U.S. Patent No. 7,582,621 is...more

Patterson Belknap Webb & Tyler LLP

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

Patterson Belknap Webb & Tyler LLP on

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

McDonnell Boehnen Hulbert & Berghoff LLP

Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017)

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In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more

McDonnell Boehnen Hulbert & Berghoff LLP

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

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The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDermott Will & Emery

When a Divisional Is Not a Divisional: No Section 121 Safe Harbor for Reissue Patentee Who Retroactively Omitted New Matter - G.D....

McDermott Will & Emery on

Addressing the “safe harbor” provision under 35 U.S.C. § 121, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. G.D....more

McDonnell Boehnen Hulbert & Berghoff LLP

The Medicines Company v. Hospira (Fed. Cir. 2015)

McDonnell Boehnen Hulbert & Berghoff LLP on

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

Foley & Lardner LLP

Federal Circuit Strikes Final Blow to Celebrex Patent

Foley & Lardner LLP on

In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more

McDonnell Boehnen Hulbert & Berghoff LLP

Group of National and State Organizations Asks Congress to Enact Legislative Reforms to Maintain Strong Patent System

McDonnell Boehnen Hulbert & Berghoff LLP on

Last month, more than 90 national and state advocacy organizations sent a letter to the leadership of the House and Senate Judiciary Committees, urging Congress to enact legislative reforms that will maintain a strong and...more

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