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America Invents Act › Pharmaceutical Industry

The Leahy-Smith America Invents Act is a United States federal statute enacted in 2011 aimed at simplifying the U.S. patent system and allowing inventions to be brough to market sooner. The AIA makes significant... more +
The Leahy-Smith America Invents Act is a United States federal statute enacted in 2011 aimed at simplifying the U.S. patent system and allowing inventions to be brough to market sooner. The AIA makes significant changes to the patent system, including changing from a first-to-invent scheme to a first-to-file scheme, eliminating interference proceedings and developing post-grant opposition.  less -
WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

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Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

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As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Irwin IP LLP

No Handling Necessary: Industry Demo Was A Public Use: Minerva Surgical, Inc. v. Hologic, Inc., 2023 WL 1999900 (Fed. Cir. Feb....

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Be careful of showing your claimed inventions at tradeshows.  On February 15, 2023, the Federal Circuit (“CAFC”) affirmed a summary judgment ruling that, by merely showcasing an embodying device at an industry event (the...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

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On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Fish & Richardson

Biosimilars 2021 Year in Review

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2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Porter Hedges LLP

Anticipating President Biden’s Intellectual Property Policy in an Historical Context

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Presidential administrations have affected intellectual property (IP) policy since the very beginning of United States history. In his first State of the Union address in 1790, President George Washington addressed patents....more

Bradley Arant Boult Cummings LLP

Drug Patent Invalid Due to Poor Quality Translation

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In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

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PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Goodwin

Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more

McDonnell Boehnen Hulbert & Berghoff LLP

Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (Fed. Cir. 2019)

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Section 112 of the Patent Act as codified, entitled "Specification" in the statute, specifies the amount of disclosure required to support a patent claim (among other requirements).  Section 112(a) contains three...more

Foley & Lardner LLP

Personalized Cancer Therapy Found Nonobvious

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In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more

McDonnell Boehnen Hulbert & Berghoff LLP

OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019)

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Last week, the Federal Circuit overturned an obviousness determination in an inter partes review by the Patent Trial and Appeal Board in OSI Pharmaceuticals LLC v. Apotex Inc.  The Court also reaffirmed its holdings in...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

Ladas & Parry LLP

U.S. Court Of Appeals For The Federal Circuit Has Held That Neither State Agencies Nor Indian Tribes Enjoy Sovereign Immunity,...

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On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...more

Robins Kaplan LLP

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

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Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more

Sunstein LLP

March 2019 IP Update - Secret Sales Trigger the On-Sale Bar under the Patent Statute, Says the Supreme Court

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Before enactment of the America Invents Act (AIA) in 2011, it was understood that an inventor’s secret commercialization of an invention through sale or use can operate like prior art against that inventor’s subsequent patent...more

McDermott Will & Emery

Mootness on Appeal from PTAB

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The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more

Shook, Hardy & Bacon L.L.P.

"Secret Sale" of Drug Counts as Prior Art in Patent Battle

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On January 22, 2019, the U.S. Supreme Court affirmed the U.S. Court of Appeals for the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229 (Jan. 22, 2019)....more

McDermott Will & Emery

Secret Sales Still Qualify as Prior Art Under AIA

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Addressing whether the on-sale bar of America Invents Act (AIA) 35 USC § 102(a)(1) applies to confidential sales where specific details are not made public, the Supreme Court of the United States found that the post-AIA...more

Akerman LLP

Waiting To File For A Patent? A Cautionary Tale

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A patent can provide incredible benefits. When a patent is infringed, the patent owner may be entitled to damages from the infringer. Also, the patent owner may be able to receive an injunction against the infringer,...more

Ward and Smith, P.A.

On-Sale Bar: Less clever way of saying, Happy Hour? Maybe. Important for Patent Protection? Yes.

Ward and Smith, P.A. on

If the term "happy hour" in this article's title caught your attention, you may be disappointed by what comes next. This article is actually about limitations on patent protection, which I would argue is just as...more

Tucker Arensberg, P.C.

United States Supreme Court Confirms the “On Sale” Bar Is Triggered Even If a Sale or Offer for Sale Does Not Make the Invention...

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Helsinn Healthcare (“Helsinn”) is the maker of certain treatments for chemotherapy-induced nausea (the “Palonosetron Products”). During the development process, Helsinn entered into two third party agreements for distribution...more

Troutman Pepper

Why Biotech and Pharma Patents Survive IPR

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When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

Goodwin

SCOTUS Holds that AIA Did Not Change the Scope of the On-Sale Bar

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On January 22, 2019, the Supreme Court issued its decision in Helsinn Healthcare v. Teva Pharmaceuticals USA, holding that under § 102(a), as amended by the American Invents Act (“AIA”), an inventor’s sale of an invention to...more

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