Gary Speier
Shareholder (Partner) and Registered U s Patent Attorney @Carlson Caspers
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WORK HISTORY
Shareholder (Partner) and Registered U s Patent Attorney @Carlson Caspers
Minneapolis, MN, US
My practice focuses on ANDA Hatch Waxman generic drug IP litigation, pre-suit investigations, post grant proceedings (e.g, inter partes review), freedom to operate (FTO), and due diligence. I am currently counsel to a number of leading generic drug companies, including those who are first-to-file with an ANDA with a Paragraph IV Certification, and thus eligible for 180-days of market exclusivity.I act as de facto IP lead for several pharma clients, advising on product selection, portfolio strategy, FTO governance, financial projections, and litigation risks with NDA/505(b)(2)/ANDA assets.BAR ADMISSIONS/CERTIFICATIONS:• Certified Licensing Professional (CLP), Licensing Executives Society (LES®)(Credential ID: 1400)• United States Patent Office (Reg. No. 45,458)• Supreme Court of the United States (Bar #: 315255)• United States Court of Appeals for the Federal Circuit• United States District Court for the District of Minnesota• United States District Court for the District of New Jersey• United States Court of Appeals for the Eighth Circuit• Minnesota (Lawyer ID: 029276X; Active)• Pennsylvania (Lawyer ID: 80345; Inactive)• New Jersey (Attorney ID: 03•••••97; Active)• North Dakota (Bar ID: 07083; Inactive)• Certified Valuation Analyst® (CVA), The National Association of Certified Valuators and Analysts® (NACVA)(NACVA Member # 10•••51; Active)
EDUCATION
Isenberg School of Management, UMass Amherst
Master of Business Administration (MBA) (Finance Focus), Finance • Accounting • Economics • Strategic Management
Temple University - James E. Beasley School of Law
Doctor of Law (J.D.)
Iona Prep (New Rochelle, NY)
High School
The Johns Hopkins University - Carey Business School
Master of Science - MS, Finance (MSF)
Incarnation (Queens Village, NY)
Grammar School
Fordham University
Bachelor of Science (B.Sc.), Chemistry
Annunciation (Crestwood, NY)
Grammar School
Villanova University
Master of Science (M.Sc.), Synthetic Organic Chemistry
SKILLS
ABOUT GARY SPEIER
SUMMARY: Registered U.S. patent attorney in the chemical and pharmaceutical technologies. I am privileged to work in the intersection of law, technology, and business.Open to 1–2 Independent Director or formal Advisory Board roles with pharmaceutical, biotech, diagnostics, and IP/analytics companies, as well as selected nonprofit or public boards in science and healthcare.Recent trial experience includes district court litigation in Laboratoire HRA Pharma v. Teva (Ella®). Recent PTAB experience includes IPRs in Pack Pharmaceuticals v. Alza Corporation (Glucotrol®), Teva v. Eli Lilly (Alimta®), Teva v. AstraZeneca (Onglyza®), and Teva v. Allergan (Restasis®).I am also a founding co-owner and managing director of a privately held pharmaceutical company. With an FDA approved facility located in Kansas City, the company focuses on identifying, developing, and commercializing niche products—505(b)(2) and P-IV ANDAs—on its own or in partnerships with other drug companies. The products span a wide-range of therapeutic indications and dosage forms. My role has required me to manage areas of business development, financing, product selection & forecasting, product development, clinical, legal, and regulatory.LEGAL AREAS: ANDA Hatch Waxman litigation and pre-suit investigation Opinion drafting– Invalidity– Non-infringement Reexaminations Inter Partes Review (IPR) Freedom-to-operate (FTO) M & As Due diligence Life cycle management FDA Regulatory Licensing/transactional IP Valuation– Patent ValuationTECHNICAL AREAS: Pharmaceuticals – NCEs (e.g, small molecules)– Methods of medical treatment (all major therapeutic areas)– Dosage forms (e.g, injectable, solid orals, thin films, etc.) Cosmetics & neutraceuticals Agricultural Industrial chemicals Plastics & Polymers Food & beverage Clean tech– Fuel cells– Biofuels and biodiesel– Batteries– Oil & Gas– Solar Process manufacturing Medical devices CannabisI moderate/own a discussion group \"Freedom to Operate (FTO) and IP Due Diligence\" on LinkedIn. I believe this is the only discussion group on LinkedIn dedicated to FTO and IP due diligence issues.
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