Anthony M. Insogna

Anthony Insogna is a Chambers-ranked life sciences patent lawyer. He brings 30-plus years of experience in enforcing and defending patents worldwide, driving portfolio strategy for therapeutic products, and conducting due diligence for corporations, investors, and private equity firms.

Anthony and his teams have achieved numerous patent litigation victories, including a $107.5 million jury award in Puma Biotechnology v. AstraZeneca, a record-breaking $2.54 billion jury award for Idenix (Merck & Co.) against Gilead, and successful enforcement and defense of patents for Kyowa Kirin's Potelligent^® platform technology, which also created new law under Section 1782. He has also successfully protected IP covering Humira^®, Revlimid^®, Abraxane^®, and many other products.

Anthony's experience in portfolio management and other IP advising includes driving portfolio strategy for Revlimid^®, Ethyol^®, Otezla^®, Lunesta^®, Thalomid^®, and dozens of other products. He advises across a breadth of technologies, including CAR-T, gene therapy, gene editing, antibodies, antibody drug conjugates (ADCs), enzyme replacement therapy, and small molecule drugs. His IP strategies have been tested in litigation and M&A diligence, e.g., Dainippon Sumitomo Pharma's $2.6 billion acquisition of Sepracor (now Sunovion), Pfizer's $1.3 billion acquisition of Esperion, Amgen's $1.3 billion acquisition of Tularik, J&J's $970 million acquisition of Cougar Biotechnology, MedImmune's $492 million acquisition of U.S. Bioscience, and Merit Medical's $100 million acquisition of BioSphere Medical.

Anthony's experience has also involved: Allegra^®, Brovana^®, Bravecto^®, Clarinex^®, Clofar^®, Embospheres^®, Ethyol^®, Focalin^®, Focalin XR^®, HepaSpheres^®, Ingrezza™, Istodax^®, Kuvan^®, Nesina^®, Nithiodote^®, Nuplazid^®, Pristiq^®, Relafen^®, Rezield, Ritalin LA^®, Synagis^®, Tyzeka^®, Vidaza^®, Xyrem^®, and Zytiga^®.

Anthony founded the Firm's San Diego Office. He was recently named a San Diego Business Journal "Leader of Influence in Law."

Expérience

Pharmaceutical company wins $107.5 million jury verdict in patent dispute involving AstraZeneca's lung cancer treatment Tagrisso^®Jones Day on behalf of a pharmaceutical company won a jury award of $107.5 million in damages after a five-day trial and less than three hours of jury deliberation.

Patent owner successfully challenges FDA regulatory review determinationJones Day successfully represented a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug.

AbbVie successfully defends HUMIRA^® formulation patent against four IPR petitions filed by CoherusJones Day served as lead counsel and successfully defended AbbVie in connection with four (4) separate inter partes review (IPR) petitions brought by Coherus Biosciences, Inc. against U.S. Patent No. 9,085,619, which is related to formulations for AbbVie's antibody adalimumab, marketed as HUMIRA^®.

Celgene wins in district court case, invalidating patent asserted against its Thalomid® and Revlimid® brand cancer drugsJones Day successfully defended Celgene Corporation in a patent infringement case brought in the United States District Court for the District of Delaware by Andrulis Pharmaceuticals Corporation, which alleged that Celgene's THALOMID® and REVLIMID® brand cancer drugs infringed U.S. Patent No. 6,140,346 ("'346 patent").

Kyowa Hakko Kirin defeats competitors in Patent Trial and Appeal Board challenge of patents on antibody technologyOn October 23, 2017, the Patent Trial and Appeal Board ("PTAB") issued a trio of decisions, unanimously declining to institute inter partes review ("IPR") of three patents owned by a Japanese pharmaceutical company represented by Jones Day, Kyowa Hakko Kirin Co., Ltd.

Idenix wins $2.54 billion jury verdict in Gilead patent dispute involving hepatitis C drugsAfter a nine day trial and less than two hours of jury deliberation, Jones Day, on behalf of Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co.), won the largest patent infringement verdict in U.S. history to date, involving a multi-billion dollar patent dispute with Gilead Sciences Inc. over sofosbuvir, the active ingredient in Gilead’s hepatitis C drugs Sovaldi^® and Harvoni^®.

AbbVie defeats IPR petition filed by Coherus challenging Humira^®Jones Day successfully defended AbbVie Inc. in connection with an IPR petition brought by Coherus Biosciences, Inc. against U.S. Patent No. 9,114,166, which is directed to formulations for AbbVie's antibody therapeutic Humira^®.

AbbVie successfully defends patents related to HUMIRA^® against IPR petitions filed by AmgenJones Day served as co-counsel in the successful defense of AbbVie Inc. in two IPRs brought by Amgen in connection with U.S. Patent Nos. 8,916,157 and 8,916,158 related to AbbVie's blockbuster antibody therapeutic, HUMIRA^®.

Celgene successfully defends REVLIMID® compound patent against Kyle Bass' IPR petitionJones Day represented Celgene Corporation in successfully defending an IPR petition filed by Coalition for Affordable Drugs VI LLC (CFAD) - a company formed by hedge fund manager Kyle Bass - against U.S. Patent No. 5,635,517, which is listed in the Orange Book for Celgene's REVLIMID® brand drug.

Akebia wins precedent-setting battle in Ninth Circuit over § 1782 discovery for use in foreign patent invalidity proceedingsOn behalf of Akebia Therapeutics, Inc. Jones Day obtained a precedent-setting decision from the Ninth Circuit to obtain key information for use in foreign patent opposition proceedings seeking to invalidate patents held by FibroGen, Inc.

Celgene prevails in district court case, beating back patent infringement claims directed against its Abraxane® brand cancer drugJones Day successfully defended Celgene Corporation and its subsidiary Abraxis BioScience, LLC in a patent infringement case brought in the United States District Court for the District of Massachusetts by Cephalon, Inc. and Acusphere, Inc. alleging Celgene's ABRAXANE® brand cancer drug infringed U.S. Patent No. RE40,493 ("the '493 patent").

AbbVie successfully faces off with Amgen in patent interference involving buffer-free antibody formulationsJones Day represented AbbVie, Inc. in a patent interference against Amgen, Inc. before the PTAB involving the parties' applications/patents generally related to buffer-free antibody formulations, including formulations to adalimumab, marketed as HUMIRA^®.

Idenix challenges Gilead's patent rights to methods of treating HCV with Sovaldi® (sofosbuvir)Jones Day represents Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in a patent interference against Gilead.

Celgene defends REMS patents against Kyle Bass' IPR petitionsJones Day is representing Celgene Corporation in defending four IPR petitions filed by Coalition for Affordable Drugs VI LLC - a company formed by hedge fund manager Kyle Bass - against U.S. Patent Nos. 6,045,501 and 6,315,720, which are listed in the Orange Book for Celgene's REVLIMID®, POMALYST®, and THALOMID® brand drugs, and which pertain to Celgene's Risk Evaluation and Mitigation Strategy (REMS)™ for those drugs.

Idenix challenges Gilead's patent rights to Sovaldi® (sofosbuvir)Jones Day represents Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in patent interference against Gilead.

Akebia successfully challenges European patentJones Day represented Akebia Therapeutics, Inc. in successfully challenging the validity of European Patent No. EP1463823 issued to FibroGen, Inc. in opposition proceedings before the European Patent Office ("EPO").

Celgene prevails in Federal Circuit challenge to its ABRAXANE® breast cancer drugOn June 17, 2015, a unanimous panel of the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of noninfringement in a case involving Celgene's ABRAXANE® breast cancer drug.

Acorda Therapeutics wins IPRsJones Day served as co-counsel in the successful defense of two of Acorda Therapeutics' Orange Book patents relating to Ampyra®, in IPRs requested by the Coalition for Affordable Drugs (ADROCA) LLC and Kyle Bass et al.

Akebia obtains favorable preliminary decision in invalidity proceedings at JPOJones Day's client Akebia Therapeutics, Inc. received a preliminary trial decision in connection with a patent invalidation proceeding at the Japan Patent Office.

Celgene acquires Abraxis BioScience for $2.9 billionJones Day advised Celgene Corporation in its $2.9 billion merger with Abraxis BioScience Inc.

Celgene establishes global patent portfolio for its brands REVLIMID^®, POMALYST^®, OTEZLA^®, VIDAZA^®, ABRAXANE^® and ISTODAX^®Jones Day assists Celgene Corporation in the establishment of its global patent portfolio related to lenalidomide (REVLIMID^®), pomalidomide POMALYST^®), apremilast (OTEZLA^®), azacitidine (VIDAZA^®), ABRAXANE^® and romidepsin (ISTODAX^®) for the treatments of cancer and immune, inflammatory conditions.

BioMarin asserts patent infringement claims against Dr. Reddy's Laboratories related to Kuvan^®Jones Day represented BioMarin Pharmaceutical, Inc. in a patent infringement action against Dr. Reddy's Laboratories relating to the defendant's submission of an Abbreviated New Drug Application to the FDA seeking approval of a generic versions of Kuvan^® (sapropterin dihydrocholride), the only FDA-approved treatment to reduce blood phenylalanine levels in persons with BH-4 responsive phenylketonuria (PKU).

Idenix enforces patent against Gilead in Germany over sofosbuvirJones Day represented Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in patent litigation against Gilead in Landgericht Düsseldorf in Germany over sofosbuvir, the active ingredient in Sovaldi^® and Harvoni^®, Gilead's blockbuster drugs for treating Hepatitis C.

BioMarin resolves patent infringement claims against Par Pharmaceutical related to Kuvan^®Jones Day client BioMarin Pharmaceutical, Inc. successfully resolved a patent infringement action against Par Pharmaceutical, Inc. relating to the defendant's submission of an Abbreviated New Drug Application to the FDA seeking approval of a generic version of Kuvan^® (sapropterin dihydrocholride), the only FDA-approved treatment to reduce blood phenylalanine levels in persons with BH-4 responsive phenylketonuria (PKU).

Akebia defends patent for prolyl hydroxylase inhibitors before European Patent OfficeJones Day advises Akebia Therapeutics, Inc. on defending a patent covering prolyl hydroxylase inhibitors before the European Patent Office.

Idenix asserts patent infringement against Gilead in Canada related to Sovaldi® and Harvoni®Jones Day represents Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in patent litigation against Gilead in Federal Court in Canada over sofosbuvir, the active ingredient in Sovaldi® and Harvoni®, Gilead's blockbuster drugs for treating Hepatitis C.

Celgene files Hatch-Waxman suit against Par Pharmaceutical over generic version of ADHD drug Focalin XR®Jones Day represents Celgene Corporation in a patent infringement action against Par Pharmaceutical brought pursuant to the Hatch-Waxman Act relating to Celgene’s patented drug Focalin XR®.

Celgene files Hatch-Waxman suit against Mylan over Focalin XR® patentsJones Day represented Celgene Corporation in a Hatch-Waxman patent infringement action against Mylan Pharmaceuticals concerning a generic version of Celgene’s branded drug Focalin XR®.

Idenix defends nucleoside analogue patent in EPO opposition against five opponentsJones Day represented Idenix Pharmaceuticals LLC (a subsidiary of Merck & Co., Inc.) in opposition proceedings before the EPO related to Idenix patent covering nucleoside analogs and prodrugs.

Celgene appeals decision from Opposition Division to revoke lenalidimide European patentJones Day represents Celgene Corporation in the appeal of a decision in opposition proceedings against two generic companies opposing a Celgene European patent covering the polymorphs of lenalidimide.

Sunesis Pharmaceuticals successfully prosecutes U.S. patent for vosaroxinOn behalf of Sunesis Pharmaceuticals, Inc., Jones Day successfully prosecuted a U.S. patent application for vosaroxin which is used in the treatment of leukemia.

Puma Biotech exclusively licenses neratinib from PfizerJones Day advised Puma Biotechnology, Inc. with the IP diligence in connection with its exclusive license of rights to neratinib from Pfizer Inc.

Infinity establishes global patent portfolio for small molecule inhibitors of FAAHJones Day assists Infinity Pharmaceuticals, Inc. in the establishment of a global patent portfolio related to small molecule inhibitors of fatty acid amide hydrolase (FAAH).

Celgene obtains dismissal with prejudice of patent infringement claims involving its Vidaza® brand drugJones Day represented Celgene Corporation in a patent infringement lawsuit involving the company’s Vidaza® brand drug that was filed by IVAX LLC in the Southern District of Florida.

Celgene defends patents covering lenalidomide and apremilast before European Patent OfficeJones Day represents Celgene Corporation in defense of patents covering lenalidomide and apremilast against oppositions brought before the European Patent Office by generic pharmaceutical companies.

BioTheryX establishes patent portfolio for anti-hematological malignancy therapiesJones Day assists BioTheryX, Inc. in the development of a global patent portfolio related to small molecule drugs for the treatment of hematological malignancies.

BioSphere Medical signs merger agreement with Merit Medical SystemsJones Day acted as IP counsel in advising BioSphere Medical, Inc. in connection with the execution of a definitive merger agreement with Merit Medical Systems, Inc., wherein Merit will acquire BioSphere in an all cash transaction valued at approximately $96 million.

Celgene files declaratory judgment action against CyclacelJones Day represents plaintiff Celgene Corporation in a declaratory judgment action for non-infringement and invalidity of four Cyclacel Pharmaceuticals, Inc. patents related to certain depsipeptides and uses thereof.

Sunovion establishes global patent portfolio for small molecule drugs for certain CNS disorders and painJones Day assists Sunovion Pharmaceuticals Inc. in the establishment of a global patent portfolio related to small molecule drugs for the treatment of certain CNS disorders and pain.

Transcept Pharmaceuticals seeks IP counseling on new product development and partnership opportunitiesJones Day is assisting Transcept Pharmaceuticals, Inc. with patent strategy on new product development and partnership opportunities.

July 2024 Commentary

Autres publications

September/October 2012
Obviousness-Type Double Patenting, Landslide, American Bar Association Vol. 5, No. 1
March 26, 2009
Fresh start for biosimilars in 2009?, The Daily Transcript, San Diego's Business Daily
1991
A Reinvestigation of the Reactions Occurring upon Photoexcitation of Cyclophexenome in the Presence of Triethylamine, The Journal of Organic Chemistry, Vol. 56, pages 1879-1882.

October 17, 2024
U.S. Trade Secrets Act, Recent Developments and What Korean Companies Need to Know, Korea Intellectual Property Association (KINPA) Conference
May 12, 2023
Considerations for Pharmaceutical Patent Protection in the U.S., BIO Korea International Convention
September 20, 2022
Overview of United States Patent Law, Peking University Law School
October 28, 2020
Landscape of United States Patent Law, Peking University Law School
February 3, 2017
Advanced IP Support of M&A Transactions in the Pharmaceutical Industry - Private Client CLE
2012年10月25日
在华投资研讨会：外商对华投资新的挑战和机遇
October 25, 2012
China Inbound Seminar: New Challenges and Opportunities for Foreign Investments in China
2012年10月24日
对外投资研讨会：中国公司全球扩展中的法律风险管理
October 24, 2012
Outbound Seminar "Managing Legal Risks in Global Expansion of Chinese Companies"
August 9, 2012
Patent Issue Forum with David Kappos of the USPTO - Trade Secrets
March 18, 2008
IP and the Life Sciences Industry, panel discussion moderator, USC Gould School of Law 2008 Intellectual Property Institute
February 20, 2008
Issues and Challenges Facing Japanese University Biotech Ventures, The University of Tokyo and Mitsui Ventures
2008
Issue and Challenge Facing Japanese University Biotech Venture
April 26, 2006
Beijing International Pharmaceutical & Chemical - Intellectual Property Forum Introduction to U.S. Pharmaceutical Litigation and Global Impact
September 28, 2005
Latest Thinking on Attacking/Defending Patent Rights in the U.S. Pharmaceutical and Biotechnology Markets, Henry Stewart Conference Studies
March 22, 2005
2005 CALBIO Conference: The Face of Medicine in the Next Decade
November, 2004
IP Biotechnology Patent Roundtable, The California Lawyer
January 12, 2004
2004 JP Morgan Healthcare Conference, Panel Discussion Current Dynamics of Patent Law in the Pharmaceutical Industry
June, 2002
Essential IP Due Diligence in Pharma/Biotech Alliance, American Conference Institute, Pharmaceutical/Biotech Collaborations and M&A
May, 2002
Are Inventors Losing Their Rights As A Result Of Recent Federal Circuit Decisions, St. John's University School of Law, Intellectual Property Lecture

Practice Leader Intellectual Property

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Expérience

Federal Circuit Revives Induced Infringement Claims Despite "Skinny Label" Carve-Out

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USPTO Announces Request for Comments: AI's Impact on Prior Art and the PHOSITA

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Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

USPTO Seeks Public Input on Improving Patent "Robustness and Reliability"

Autres publications

Anthony M. Insogna

Practice Leader Intellectual Property

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