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Patent Validity Pharmaceutical Industry

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim 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

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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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

Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

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The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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*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

Goodwin

PTAB Issues Final Written Decisions Finding Claims of Recombinant Lentiviral Vector Patents Valid

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​​​​​​​On April 22, 2024, the PTAB issued final written decisions in IPR2023-00070 and IPR2023-00074, filed by Bluebird Bio on two patents related to recombinant lentiviral vectors — U.S. Patent Nos. 7,541,179 and 8,058,061,...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Mintz - Intellectual Property Viewpoints

Picture Claims as an Effective Patent Strategy: Top 10 Reasons to Precisely Tailor Your Patent Claim

A “picture” claim refers to a patent claim precisely tailored to track a particular product’s important advantages and features. When drafting a patent application, one should describe various embodiments of the invention and...more

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Will Not Read Safety and Efficacy Limitations into Pharma Method Claims

On July 24, in United Therapeutics Corporation v. Liquidia Technologies, Inc., the Federal Circuit addressed whether safety and efficacy are required for pharmaceutical method claims to be sufficiently enabled and supported...more

American Conference Institute (ACI)

[Event] C5’s 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe - May 23rd - 24th, Amsterdam, Netherlands

Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Smart & Biggar

Federal Court of Appeal upholds validity of two patents relating to ELIQUIS

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On August 4, 2022, the Federal Court of Appeal (FCA) dismissed Pharmascience’s appeal of a Federal Court decision upholding the validity of Canadian Patent Nos. 2,461,202 (the 202 patent) and 2,791,171 (the 171 patent)...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

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RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Smart & Biggar

Merck’s JANUVIA crystalline monohydrate DHP salt patent found valid

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In a patent infringement action brought under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, in relation to sitagliptin phosphate monohydrate (Merck’s JANUVIA), Justice Furlanetto of the Federal...more

Smart & Biggar

Federal Court finds formulation patent relating to ACTONEL DR valid but not infringed

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On February 23, 2022, the Federal Court issued its public reasons for judgment in a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to risedronate...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...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

Smart & Biggar

Federal Court of Appeal Upholds Decision Allowing Taro to Plead Validity Attacks beyond Notice of Allegation

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On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more

Smart & Biggar

Federal Court upholds validity of one pneumococcal vaccine patent, but holds two other patents invalid

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Update: Wyeth’s appeal was discontinued. On April 30, 2021, the Federal Court issued its decision relating to the validity of three patents relating to Pfizer’s PREVNAR 13, a 13-valent pneumococcal polysaccharide protein...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

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On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

Smart & Biggar

Federal Court of Appeal sets aside Order for common trial across multiple actions under PMNOC Regulations

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An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more

Kramer Levin Naftalis & Frankel LLP

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

International Lawyers Network

Information on Filed Applications for Registration of Drugs has Become Publicly Available in Russia

Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more

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