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America Invents Act › Pharmaceutical Industry › Pharmaceutical Patents

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 -
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

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

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

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

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

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

Latham & Watkins LLP

Supreme Court Says a Secret Sale Qualifies as Prior Art Under AIA

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Helsinn confirmed that the AIA did not alter the meaning of the “on-sale” bar. In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc, the Supreme Court addressed whether a confidential sale of an invention to a...more

McAfee & Taft

Gavel to Gavel: Supreme Court provides clarity

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Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more

Polsinelli

Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the...

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The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act...more

Weintraub Tobin

Can Secret Sales Prohibit Patenting Your Invention?

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Prior to the Leahy-Smith America Invents Act (“AIA”), the patent statute (35 U.S.C. § 102(b)) prohibited patenting an invention that was “on sale in this country, more than one year prior to the date of the application for...more

Fish & Richardson

The “On Sale Bar” Remains a Trap for the Unwary

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Inventors should not delay the filing of their patent applications, and preferably should file within one year of any commercialization of the invention, as confirmed by the Supreme Court on January 22, 2019....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2019 #3

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PATENT CASE OF THE WEEK - Mark A. Barry v. Medtronic, Inc., Appeal No. 2017-2463 (Fed. Cir. Jan. 24, 2019) - On Thursday, the Federal Circuit issued a significant decision affirming the district court’s rulings related...more

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