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Irena Royzman, Ph.D.

Partner

New York

Irena Royzman is a nationally recognized life sciences IP litigator, representing pharmaceutical and biotechnology innovators in their highest stakes disputes.

With a Ph.D. in biology from MIT and the Whitehead Institute, where she was a NSF fellow, Irena represents plaintiffs and defendants in their most complex pharmaceutical and biotech patent cases. Over the last 20 years, pharmaceutical and biotechnology innovators have relied on Irena again and again for cases involving small molecules, biologics, recombinant DNA technology, gene therapy, gene editing, manufacturing processes, formulations and drug-eluting medical devices, including numerous multi-billion dollar cases involving many of the world’s best-selling drugs.

Irena has significant experience in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA), as well as inter partes review (IPR) proceedings, license disputes and matters with parallel ex-U.S. litigation and proceedings in foreign patent offices. Irena also helps life sciences companies and organizations develop the law in the most important cases for the biopharma industry. She has been principal counsel on numerous amicus briefs to the United States Supreme Court and the Federal Circuit in key biopharma cases.

For plaintiffs, Irena has successfully defended generic challenges to patents protecting blockbuster medical therapies, including multi-billion dollar cancer, antiviral and anti-psychotic drugs. She has also represented an innovator in some of the first cases under the BPCIA, including the first involving an antibody. For defendants, she defeated a $530 million claim of patent infringement of a competitor’s biotech patent, obtaining dismissal of all claims and discovery sanctions against the patent owner. In another high-stakes case, she obtained summary judgment of noninfringement and exclusion of plaintiff’s experts under Daubert as well as a full award of attorneys’ fees.

A registered patent attorney, Irena also handles inter partes review (IPR) proceedings. For patent owners, she has obtained denial of IPR for patents protecting blockbuster drugs and has leveraged IPR for defendants to obtain freedom to operate.

Irena also coordinates U.S. proceedings with parallel ex-U.S. litigation and proceedings in foreign patent offices, recently obtaining freedom to operate for a biotech innovator’s gene therapy. She provides strategic counseling in biologics and pharmaceuticals and advises clients on their IP portfolios and transactions. Irena also represents clients in high-stakes license disputes involving biotech patents, and, in a dispute concerning the use of a recombinant protein as an enzyme replacement therapy, obtained one of the largest settlement awards over the life of the contract.

Chambers USA has recognized Irena as a leading lawyer in intellectual property, where clients have described her as “excellent,” “knowledgeable, aggressive” and “an incredibly smart lawyer.” Benchmark Litigation named her one of the “Top 250 Women in Litigation” for the last six years and a litigation star in intellectual property in New York. Irena was also named to the Crain’s New York Business 2021 list of Notable Women in Law.

Irena writes and lectures widely on biopharma patent issues and biosimilar litigation.  Irena also is frequently quoted on patent-related issues, including in the Washington Post, Financial Times, Nature Biotechnology and Pink Sheet.

  • Patent Litigation - Hatch-Waxman

    • Represnting a major pharmaceutical company in an ANDA action involving challenges by multiple generic companies to patents protecting a blockbuster four-drug fixed-dose combination for the treatment of HIV infection.
    • Representing a major pharmaceutical company in an ANDA action involving challenges by a generic company to four patents protecting a blockbuster cancer therapy. After trial, the district court rejected all the invalidity theories for each of the patents and the Federal Circuit affirmed.
    • Successfully represented two pharmaceutical innovator companies in ANDA actions involving challenges by multiple generic manufacturers to formulation and manufacturing patents protecting a cancer therapy. After several of the defendants abandoned their invalidity and non-infringement theories and converted their PIV certification to a Paragraph III certification, obtained an injunction enjoining defendants from infringing the patents through their expiration and a report and recommendation finding the case to be exceptional for discovery misconduct and warranting attorneys’ fees.
    • Successfully represented a major pharmaceutical company in ANDA actions involving challenges by multiple generic manufacturers to patents protecting a breakthrough treatment for cGVHD and certain B-cell cancers.
    • Successfully represented a pharmaceutical innovator in a patent infringement action against a 505(b)(2) applicant involving a long-acting treatment for schizophrenia and bipolar disease.
    • Successfully represented a major pharmaceutical company in an ANDA action involving challenges to eight patents protecting a combination drug treatment for HIV/AIDS.
    • Successfully represented a major pharmaceutical company in an ANDA action involving challenges by multiple defendants to patents covering the crystalline form and processes for the manufacture of a blockbuster drug. Obtained summary judgment of infringement. The court found all patents valid and enjoined defendants from infringing the patents.
    • Successfully represented a major pharmaceutical company in an action involving infringement of a patent covering the manufacture of a key component of an HIV drug.
    • Successfully represented a major pharmaceutical company in an ANDA action involving validity challenges by multiple generic manufacturers to patents covering our client’s blockbuster protease inhibitor and methods of its use. After two years of litigation and the close of fact discovery, defendants abandoned their validity challenges and converted their Paragraph IV certifications to Paragraph III certifications.
    • Obtained a judgment of infringement and validity and enjoining defendants from infringing manufacturing patents.
    • Successfully represented a major pharmaceutical company in an ANDA action involving validity and enforceability challenges by multiple defendants to a patent covering a multibillion-dollar antipsychotic drug.

    Patent Litigation - BPCIA and Biotechnology

    • Representing a biotech innovator in multiple Section 1782 proceedings in support of cross-border biosimilar litigation involving a blockbuster retinal therapy.
    • Defeated a $530 million claim of patent infringement of a competitor's recombinant DNA vector patent, obtaining for a biopharma innovator a judgment of noninfringement, the dismissal with prejudice of all claims and discovery sanctions against the patent owner.
    • Obtained discovery in a Section 1782 proceeding for a pharmaceutical innovator, resulting in the invalidation of an antibody glycosylation patent in the United Kingdom.
    • Represented an innovator company in one of the first cases under the legislation for biosimilars (BPCIA) and the first involving an antibody product.
    • Obtained summary judgment of noninfringement based on a series of antibody tests in a case concerning a drug’s mechanism of action.
    • Successfully represented a biotech company in a declaratory judgment action concerning point-of-care diagnostics.
    • Successfully represented a biotech company in a patent infringement action involving analysis of PCR amplified sequences.
    • Successfully defended a major pharmaceutical company in a lawsuit arising from a licensing dispute challenging the validity of biotech patents concerning the cotransformation of eukaryotic cells.

    Patent Litigation - Medical Devices

    • In a case involving patents to surgical devices, obtained summary judgment of noninfringement and exclusion of two experts under Daubert, as well as an award of attorneys’ fees.
    • On appeal to the Federal Circuit, obtained reversal of a judgment of nonobviousness in a high-stakes case involving drug-eluting coatings.
    • On appeal to the Federal Circuit, obtained dismissal of a $593 million judgment in a case involving coronary stents.
    • Obtained reversal of a judgment that two related medical device patents were procured by inequitable conduct.

    Inter Partes Reviews

    • Successfully represented a biopharma innovator in an inter partes review (IPR) of an expression vector patent, securing the dismissal with prejudice of the parallel district court litigation.
    • On appeal to the Federal Circuit, obtained reversal of an unpatentability determination for a claim protecting the therapeutic use of a recombinant protein.
    • Obtained a final written decision rejecting a generic manufacturer’s challenge to a patent protecting our client’s blockbuster injectable product.
    • Obtained the denial of a generic manufacturer’s petition for IPR of a patent protecting our client’s long-acting antipsychotic treatment.
    • Obtained the denial of a generic manufacturer’s petition for IPR of a patent covering a crystal polymorph of a blockbuster drug.

    License Disputes

    • In a patent license dispute concerning the use of a recombinant protein as an enzyme replacement therapy, obtained one of the largest settlement awards over the life of a contract.
    • In a patent license dispute involving a blockbuster biotech product, obtained dismissal of plaintiff’s claims and an award of attorneys’ fees.
    • Successfully represented a medical device company in a license dispute involving patents to the use of an antiproliferative drug.
    • Successfully represented an orthopedic company in a license dispute involving patents to the use of biodegradable drug-containing coatings.

    Other Patent Matters

    • Developed worldwide patent strategy, including for oppositions, and obtained freedom to operate for a biotech innovator’s gene therapy product in key foreign jurisdictions.
    • Counseled clients on a wide range of intellectual property matters, drafted validity and infringement and freedom-to-operate opinions for biotech and pharmaceutical clients and negotiated and drafted settlement and license agreements.
    • Developed the strategies and managed worldwide prosecution for patent applications and patents concerning the therapeutic use of a recombinant protein, including oppositions and appeals.

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