Gary is a registered US patent attorney with a focus on issues facing companies in the life sciences sectors. He is a patent litigator who provides counsel on a broad range of patent-related matters and regularly conducts pre-suit investigations, intellectual property valuations and IP due diligence. Gary provides freedom-to-operate clearance reviews and opinions relating to infringement and validity and develops patent procurement and patent prosecution strategies for domestic, international, and foreign jurisdictions. He has been involved in numerous post-grant proceedings (e.g., ex parté reexaminations and inter partes reviews) in front of the US Patent and Trademark Office (USPTO). The post-grant proceedings have involved patents across diverse technology areas (e.g., medical devices, drug delivery systems, polymers, pharmaceuticals, new chemical entities, and process manufacturing).
Gary has a strong technical and scientific background and extensive firsthand experience in USPTO practice and procedure. For the past several years, Gary has devoted significant time to preparing opinions relating to pharmaceutical patents and has prepared and served numerous Hatch Waxman “Paragraph IV” notice letters and detailed statements. He also has represented generic pharmaceutical companies in ANDA patent litigations.
In addition to his work in the pharmaceutical arena, Gary’s practice covers a variety of other technologies, including medical devices, drug delivery systems, natural products, nutraceuticals, polymers, biofuels, renewable energy, sustainable chemistry, process manufacturing, solar silicon purification, agriculture, pesticides and organic synthesis.
After earning his graduate degree in chemistry, Gary worked as a medicinal chemist at Sterling Winthrop Pharmaceuticals, where he designed and synthesized candidate inhibitors of the cysteine protease enzyme, Interleukin–1–ß Converting Enzyme (ICE), for the treatment of chronic inflammatory diseases. During law school, Gary worked as a law clerk in the patent group at SmithKline Beecham (now Glaxo SmithKline).
Gary has co-authored several peer-reviewed articles published in scientific journals and is a named inventor on several US patents. He has been an invited lecturer in the United States, Europe, and Asia on various IP matters, including freedom to operate, Paragraph IV opinions and IP valuation. He is also the owner and moderator of the Freedom to Operate (FTO) and IP Due Diligence discussion group on LinkedIn. In 2004, he was named by Super Lawyers as a “Rising Star.” Gary is listed in the 2020 – 2023 Best Lawyers® in America annual editions.
Temple University School of Law, JD
The Johns Hopkins University – Carey Business School, Master of Science – MS Finance (MSF)
University of Massachusetts, Amherst, MBA, Finance, Beta Gamma Sigma
Villanova University, MSc Chemistry
Fordham University, BSc Chemistry, Sigma Xi
Minnesota Supreme Court
New Jersey Supreme Court
North Dakota Supreme Court
Pennsylvania Supreme Court
US District Court for the District of New Jersey
U.S. District Court for the District of Minnesota
U.S. Court of Appeals for the Federal Circuit
Supreme Court of the United States
US Patent and Trademark Office
Teva v. Eli Lilly (pemetrexed disodium)
Carlson Caspers represents Teva in three Inter Partes Reviews [IPR2016-01343; IPR2016-01341; and IPR2016-01340] concerning Teva’s Paragraph IV ANDA challenge of 1 patent covering methods of using the active pharmaceutical ingredient (API) present in the...
Teva V. AstraZeneca (saxagliptin HCI)
Carlson Caspers represents Teva in an Inter Partes Review (IPR) concerning Teva’s Paragraph IV ANDA challenge of 1 patent covering the active pharmaceutical ingredient (API) present in the drug saxagliptin hydrochloride (Onglyza®), compositions containing...
Teva v. Allergan (cyclosporine)
Carlson Caspers represents Teva in an Inter Partes Review [IPR2017-00576; IPR2017-00578; IPR2017-00579; IPR2017-00583; IPR2017-00585; and IPR2017-00586] concerning Teva’s Paragraph IV ANDA challenge of 1 patent covering the active pharmaceutical ingredient (API) present in the drug...
Pack Pharmaceuticals v. Alza Corporation (glipizide)
Gary Speier while at a previous law firm represented Pack in an Inter Partes Review concerning Pack’s Paragraph IV ANDA challenge of 1 patent covering the formulation of glipizide (Glucotrol® XL) [IPR2014-00868]. He achieved...
Laboratoire HRA Pharma v. Teva Pharmaceuticals USA, Inc. (ulipristal)
We represented Teva, the first-to-file, in a Paragraph IV Hatch Waxman action which challenges the infringement and/or validity of four patents covering the formulation and method of using the drug ulipristal (ella®). The case...
Best Lawyers in America®
Gary was listed in Patexia’s ANDA Litigation Intelligence Report, 2022 Edition, recognizing Carlson Caspers as among the Top 10 ANDA Best Performing Firms and the Top 25 Most Active Firms for Hatch-Waxman Litigation.