Patent Information Users Group, Inc.

Finnegan webinar: Recent Developments in Patent Law: Non-Obviousness of Chemical and Pharmaceutical Patents

Wednesday, August 26, 2020 10:00 - 11:00 a.m. PDT | 1:00 - 2:00 p.m. EDT | 19:00 - 20:00 CEST

 

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 Join a discussion on recent developments in patent law, particularly the non-obviousness of chemical and pharmaceutical patents. During the interactive webinar, you will be apprised of these developments, which can substantially impact patent protection of chemical and pharmaceutical innovations.

Topics to be discussed include:

• Chemical and pharmaceutical development is highly complex and uncertain, and various approaches are not “obvious to try”
• Hindsight reasoning is legally improper and cannot be used to invalidate patent claims
• Evidence of secondary considerations, such as long-felt unmet need and unexpected results, can support a finding of non-obviousness

Speakers:

Justin Hasford,  Partner, Speaker

Justin Hasford has experience in all areas of intellectual property law. His practice focuses on complex patent litigation at the trial and appellate levels on behalf of pioneer pharmaceutical companies. He has particular experience with cases arising from Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act.

Matthew Hlinka, Attorney, Speaker

Matthew Hlinka focuses on patent and trade secret litigation before U.S. district courts, primarily in the areas of pharmaceuticals and chemical products.

Pejmon Pashai, Attorney, Moderator

Pejmon Pashai concentrates his practice primarily on patent litigation, specifically Abbreviated New Drug Application (ANDA) challenges for brand pharmaceutical manufacturers

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https://www.finnegan.com/en/insights/events/recent-developments-in-patent-law-non-obviousness-of-chemical-and-pharmaceutical-patents-082620.html

© Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

 

Related information: 

Renison, A., Hlinka, M.J., Hasford, J.J.  Recent Developments In Patent Law: Non-Obviousness Of Pharmaceutical Formulations. mondaq. 04 September 2019. [Previously published in Bloomberg Law, August 29, 2019.]

Fish & Richardson’s webinar Special Topics Related to Obviousness in the Context of Drug Development (recorded June 23, 2023) (‘Basic Obviousness Framework’ at 15:32-20:33, slides  16-20 and “Reasonable Expectation of Success” at  38:34-46:13; slides  29-35)

USPTO Manual of Patent Examining Procedure

Obviousness, 35 U.S.C. 103, in general:

Sec. 2141 Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103

Sec. 2142 Legal Concept of Prima Facie Obviousness

[Pharmaceutical Patent Applications]

Sec. 2143 [Examples of Basic Requirements of a Prima Facie Case of Obviousness]:
Sec. I A [Combining Prior Art Elements According to Known Methods To Yield Predictable Results] Ex. 3;
Sec. IB [Simple Substitution of One Known Element for Another To Obtain Predictable Results] Ex. 8-11;
Sec. 1E ["Obvious To Try" – Choosing From a Finite Number of Identified, Predictable Solutions, With a Reasonable Expectation of Success] Ex. 1-7

ACS Members also have access to the following ACS webinars presented by Justin Hasford of Finnegan, Henderson, Farabow, Garrett & Dunner

Recent Developments in Patent Law: Non-Obviousness of Chemical and Pharmaceutical Formulation Patents. Recorded July 18, 2019.

How does the law remain favorable toward the validity of chemical and pharmaceutical formulation patents?

Join Partner Justin Hasford of Finnegan, Henderson, Farabow, Garrett & Dunner as he explores the recent developments in patent law and in particular non-obviousness of chemical and pharmaceutical formulation patents. During this free interactive broadcast you will be apprised of these developments, which can substantially impact patent protection of chemical and pharmaceutical innovations.
 - Chemical and pharmaceutical formulation technology is highly complex, and various approaches are not “obvious to try”
- Hindsight reasoning is legally improper and cannot be used to invalidate patent claims
- Conclusory, unsupported expert testimony is likewise legally improper and cannot be used to invalidate patent claims

Hot Topics in Patent Law: Non-Obviousness of Chemical and Pharmaceutical Patents. Recorded August 6, 2015.

 The world of patent law is constantly changing and it can pay to keep on top of things. Join us as Justin Hasford explores the recent decisions from the Court of Appeals for the Federal Circuit concerning the non-obviousness of patent claims directed to chemical and pharmaceutical innovations.
- Mere similarity between a patented chemical composition and a prior art chemical composition does not render the patented invention invalid as obvious.
- Prior art that addresses a different problem does not render a patented invention invalid as obvious.
- An overly narrow statement of the problem, or defining the problem in terms of the patented solution, is an improper form of hindsight and does not render a patented invention invalid as obvious

Dhulap, S., Kulkarni, M., 2019. Nonobviousness of pharmaceutical inventions: implications for patent prosecution and litigation. Pharmaceutical Patent Analyst 8, 91–107. https://doi.org/10.4155/ppa-2019-0014

…This paper tries to show how the lead compound requirement is consistent with 35 U.S.C. § 103; the prima facie obviousness challenge can be overcome; the two-prong approach is consistent with the Supreme Court’s KSR v. Teleflex, 2007 (KSR) decision. The showing is illustrated with the analysis of new molecular entities in the proton-pump inhibitor family.

 Irving, T., Stevens, L.L., Lee, S.M.K., 2009. Nonobviousness in the U.S. Post-KRS for Innovative Drug Companies. U. Dayton L. Rev. 34, 157. (posted on the Finnegan website)

…This article seeks to show how the KSR decision re-emphasized certain aspects of obviousness precedent in the U.S. and modified others. In an effort to achieve that purpose, we consider the Supreme Court’s KSR decision itself and then examine how it has been applied to pharmaceutical inventions by the Court of Appeals for the Federal Circuit (CAFC).

Eisenberg, R.S. [University of Michigan Law School], 2008. Pharma’s Nonobvious Problem. Lewis & Clark L. Rev. 12,  No. 2. 375–420. (Full text)

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents.   … KSR is more likely to have an impact on pharmaceutical patents if it makes it easier for the PTO to reject patent applications for obviousness in the first instance.