Author

Richard Bone
McDermott Will & Emery LLP, Menlo Park, CA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 2:15PM
"Extensions to Patent Term in the U.S. & Worldwide"

Abstract

The U.S. has also for almost two decades operated a scheme for compensating all patentees for certain types of delay that occur  during examination of a patent application. This system has been tested in litigation many times now, invariably by pharmaceutical companies. I will explain the basic structure of patent term adjustment calculation, illustrated by several of the key cases that have probed potential ambiguities in the statutory framework. I will also explain the potential perils of obviousness type double patenting in complex patent families. The combination of patent term adjustment and patent term extension offers a unique framework for maximizing patent term in the U.S.

Author

Jess Gledhill
FB Rice, Sydney, New South Wales

John Landells
FB Rice, Melbourne, Victoria, Australia

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 2:15PM
"Extensions to Patent Term in the U.S. & Worldwide"

Abstract

Getting the most value out of aging key patents means exploring options to extend patents past their standard 20 year term. Only some countries allow for such patent term extensions and there are varying differences between those countries. This presentation will address the legal requirements for patent term extensions relating to pharmaceutical patents in Australia and Singapore, the two countries in the region that permit patent term extensions. In particular, the presentation will explore the value and difficulties in obtaining patent term extensions including conditions that must be satisfied for the grant of an extension of term (including claim type), calculation of extension term, rights during the extension period, and relevant recent case law. The presentation will also address the more broadly available form of supplemental protection,  that being data exclusivity (the protection of clinical test data), in Australia, New Zealand and South East Asia (including Singapore, Malaysia and Vietnam).

Author

Isobel Finnie
Haseltine Lake LLP, Bristol, UK

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 2:15PM
"Extensions to Patent Term in the U.S. & Worldwide"

Abstract

Holders of patents to medicinal products in Europe must use Supplementary Protection Certificates (SPCs) to secure extensions of protection as compensation for delays to marketability arising from the regulatory approval process. SPCs, though creatures of national patent offices, have given rise to a unique body of case law, at the national level as well as at the Court of Justice of the European Union. We will review the statutory framework that governs SPC practice, as well as strategies for obtaining SPCs in as many European jurisdictions as is practicable.

Author

Kristin Connarn, McDermott
Will & Emery LLP, Boston, MA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 2:15PM
"Extensions to Patent Term in the U.S. & Worldwide"

Abstract

Patent term extension (PTE) is a valuable benefit to developers of patented small molecule pharmaceutical products that exists within the Hatch Waxman framework. Nevertheless, the PTE statute, 35 U.S.C. § 156, embodies limitations that are quite stringent and mean that most patent holders need to strategize carefully in order to maximize the potential extension to term that can be afforded. Although there has been only a small amount of litigation to test the language of 35 U.S.C. § 156, the cases that have been decided have had an important impact on defining the scope of the extension.

Author

Richard Bone
McDermott Will & Emery LLP, Menlo Park, CA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 2:15PM
"Extensions to Patent Term in the U.S. & Worldwide"

Abstract

This symposium will address methods of obtaining patent terms that extend beyond the normal 20-year terms afforded by most countries. The Hatch-Waxman regime in the U.S. provides a system for awarding extensions to patent term for drug products that have been subjected to a regulatory approval process. Patent Term Adjustment is now also a key component of a strategy to extend U.S. patent term. Other countries worldwide offer Supplementary Protection Certificates to provide patentees with extended coverage for products that have received marketing authorization. These provisions, when coupled with data exclusivity possibilities, provide a valuable extension of rights for approved drug products. 

Author

Dr. Brian Trinque
Lathrop Gage LLP, Boston MA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 9AM
"Developments in Pharmaceutical Patent Law"

Abstract

Pharmaceutical patent practitioners implement IP strategies for medicines well beyond the granting of a basic composition-of-matter patent. Novel formulations, combination therapies, dosing strategies, and patient stratifications are just a few examples of the discoveries arising from clinical development that can inspire new patent applications, which will protect these inventions, and, importantly, extend patent protection for a product. Practitioners must often strike a balance between the trifecta of the examples, which illustrate the discovery and serve as a building block for the filing; the specification, which provides an invention narrative that advocates for successful patenting; and, finally, claim breadth, which one hopes to maximize, but is grounded by the realities of novelty, obviousness, written description, and enablement. The Forest Labs., Inc. v. Teva Pharms. USA, Inc., decision, which was released at the end of 2017, and The Medicines Co. v. Mylan decision before it, are important reminders that claim definiteness must be given equal weight when preparing applications directed toward such “second generation” pharmaceutical discoveries. In particular, these decisions show that our definiteness requirements can impact patent prosecution, as well as claim interpretation and validity during an infringement action.

Author

Dr. Benjamin A. Vaughan and Dr. Nicole Sassu
Lathrop Gage LLP, Boston MA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 9AM
"Developments in Pharmaceutical Patent Law"

Abstract

This lecture provides an overview of obviousness as it relates to pharmaceuticals and commercial drug formulations. Additionally, patent strategies and the most recent federal circuit cases relating to “second generation” filings, which are directed toward discoveries involving previously  known pharmaceuticals, such as pharmaceutical formulations, dosing strategies, and combination therapies will be discussed. Relevant case law related to second generation filings will be reviewed to provide important insight into effective patent specification and claim drafting strategies for such discoveries. This presentation will be useful to those with all levels of experience in pharmaceutical patent law.

Author

Dr. Andrew Ehle
Lathrop Gage LLP, Boston MA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 9AM
"Developments in Pharmaceutical Patent Law"

Abstract

Determining inventorship is a crucial part of intellectual property law. Often, disputes about who should be listed as an inventor on a given patent application can only be resolved by examining the specific contributions of each person involved in the research that led to the patentable material. To examine the legal context for what constitutes “significant contribution to the invention,” and thereby inventorship, several key Federal Circuit Cases will be discussed. This presentation will be useful to those with all levels of experience in pharmaceutical patent law.

Author

Dr. Brian Trinque
Lathrop Gage LLP, Boston MA

Presentation

256th ACS National Meeting - Boston
Monday, August 20, 2018, 9AM
"Developments in Pharmaceutical Patent Law"

Abstract

The pharmaceutical patenting process includes identifying an invention, writing a patent application that protects that invention, and prosecuting the application before the U.S. Patent Office (and patent offices throughout the world). A basic understanding of this process is a must for any scientist (academic, industrial, or otherwise). This talk will provide an overview of our current patent laws, and demonstrate how those laws are applied to a variety of pharmaceutical innovations, such as novel chemical entities and formulations. This talk will also provide a foundation for understanding the rest of today’s discussions.