Overview
Irena Royzman focuses on biotech and pharmaceutical patent litigation. She has successfully represented biotech, pharmaceutical and medical device companies as plaintiffs and defendants in patent litigation on a wide variety of subject matters, such as small molecules, biologics, analysis of polymerase chain reaction (PCR) products, genetic transformation techniques, and drug-eluting coatings. Ms. Royzman has extensive experience in litigating cases brought under the Hatch-Waxman Act and has been involved in all aspects of patent litigation, from pre-suit investigation to patent trials and appeals. In addition to patent litigation, Ms. Royzman has successfully represented biotech and pharmaceutical clients in high-stakes license disputes involving biotech patents. She also advises clients on potential infringement and validity of biotech and pharmaceutical patents as well as contractual issues.
Ms. Royzman holds a Ph.D. in Biology from the Massachusetts Institute of Technology, where she was a NSF fellow and studied the regulation of DNA replication and amplification. Through her research at MIT and the Whitehead Institute, Ms. Royzman has hands-on experience in recombinant DNA technology, cell biology and genetics.
Representative Matters
Patent Litigation
Hatch-Waxman
Successfully represented a major pharmaceutical company in an ANDA action involving validity and enforceability challenges by multiple defendants to a patent covering our client's multi-billion dollar drug. Affirmed by Federal Circuit.
Obtained dismissal of a generic manufacturer's declaratory judgment action for lack of subject matter jurisdiction. Affirmed by Federal Circuit.
Representing major pharmaceutical company in an ANDA action involving validity challenges by multiple defendants to patents covering our client's blockbuster drug.
Biotechnology
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 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.
Medical Devices
Obtained summary judgment of noninfringement and exclusion of two experts under Daubert in a case involving surgical devices. Affirmed by Federal Circuit.
On appeal to the Federal Circuit, obtained reversal of judgment of nonobviousness on behalf of a defendant in a high-stakes case involving drug-eluting coatings.
Obtained reversal of a judgment that two related medical device patents were procured by inequitable conduct. Affirmed by Federal Circuit.
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.
Successfully represented a medical device company in a license dispute involving patents to the use of an anti-proliferative drug.
Representing major pharmaceutical company in a license dispute involving a biotech patent and one of the world's best-selling biotech products.
Other Patent Matters
Counseled clients on a wide range of intellectual property matters; drafted validity and infringement and freedom to operate opinions for biotech and pharmaceutical clients; negotiated and drafted settlement and license agreements.
Obtained dismissal of a false marking action alleging that our client marked its products with inapplicable patents for failure to state a claim.
Obtained dismissal of a false marking action for failure to meet the pleading requirements for a claim of fraud after successfully transferring the action from the Eastern District of Texas to our client's home district.
Defending law firm in a malpractice action involving a biotech patent.