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America Invents Act › 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 -
Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

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On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...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

McDermott Will & Emery

Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

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In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding...more

McDonnell Boehnen Hulbert & Berghoff LLP

SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on

One of the wonderful (as in, it makes one wonder) and frustrating (which needs no explanation) aspects of patent law is that just when you think a question is settled it either isn't or the conventional interpretation is...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

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

2021 PTAB Year in Review: Analysis & Trends: Biologics at the PTAB: Statistics and Insights into Notable Biologics Decisions

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

In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

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

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...more

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

2021 PTAB Year in Review: Analysis & Trends

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

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

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

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

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

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

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

[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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

McDonnell Boehnen Hulbert & Berghoff LLP on

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....more

Mintz - Intellectual Property Viewpoints

PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

Mintz - Intellectual Property Viewpoints on

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more

Bradley Arant Boult Cummings LLP

Drug Patent Invalid Due to Poor Quality Translation

Bradley Arant Boult Cummings LLP on

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

Knobbe Martens

Balancing Intellectual Property (IP) Interests with National Interest in Response to the Coronavirus

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Traditionally, it has been fairly uncommon to see new legislation in intellectual property (IP) law, compared to other areas of law. Instead, courts have generally been the avenue through which changes in IP law have been...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)

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2019

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PATENT CASE OF THE WEEK - BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., Appeal Nos. 2019-1643, -1644, -1645 (Fed. Cir. Aug. 29, 2019) - Our case of the week this week focuses on Section 314(d)—the...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

McDermott Will & Emery

Merely Articulating a Goal Does Not Provide Reasonable Expectation of Success

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The US Court of Appeals for the Federal Circuit affirmed a district court non-obviousness decision, finding that a prior art reference that articulates a goal without explaining how that goal is achieved does not provide a...more

Jones Day

Confidential FDA Communications as Prior Art in Hatch-Waxman Litigation

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The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

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