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Biopharmaceutical Patents Prescription Drugs

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

Foley & Lardner LLP on

Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

Smart & Biggar on

Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Bolar Exemptions in North America

Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

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Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

McDonnell Boehnen Hulbert & Berghoff LLP

GEN Compiles List of Top Biopharma R&D Spenders

Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012"). The biotech...more

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