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Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...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

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

[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

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Chinese Patent Linkage, Patent Term Adjustment, and Patent Term Extension Guidelines Unveiled For Comments

On August 3, 2021, the China National Intellectual Property Administration (CNIPA) released the Draft Revised Patent Examination Guidelines (“Draft Guidelines”) for comments. The revisions in the Draft Guidelines reflect the...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Wilson Sonsini Goodrich & Rosati

Selected Favorable Pharmaceutical Intellectual Property Provisions of the USMCA

After more than a year of negotiations, the U.S., Mexico, and Canada recently concluded the United States-Mexico-Canada Agreement (USMCA). The USMCA, when it takes effect, will replace the North American Free Trade Agreement...more

Hogan Lovells

France – Rejection of a second SPC for a biological medicinal product

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Cour de cassation, Commercial Chamber, 16 May 2018, No. 16-21638 - The French Cour de cassation upholds the Paris Court of Appeal’s decision to reject an SPC application for a biological medicinal product which was based...more

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

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Patterson Belknap Webb & Tyler LLP

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

Jones Day

Clarifying or Conforming? The EPO Bows to the European Commission

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In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Robins Kaplan LLP

When Time is Money

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As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Patterson Belknap Webb & Tyler LLP

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

McDermott Will & Emery

BPCIA 180-Day Notice of Intent to Market a Biosimilar Is Required, Enforceable by Injunction

In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more

Patterson Belknap Webb & Tyler LLP

Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The...more

K&L Gates LLP

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

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The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

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