Patent term adjustment in the U.S.

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.

Patent term extensions and data exclusivity in Australia, New Zealand and South East Asia

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).

Supplementary protection certificates in the European Union

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.

Patent term extension in the U.S.

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.

Extensions to patent term in the U.S. and worldwide

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. 

Definiteness and the Medicines Co. and Forest Labs. Decisions

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.

Obviousness, the CAFC, and Second Generation Filing Strategies

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.

What Constitutes an Inventor? A Review of Federal Circuit Case 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.

Pharmaceutical Patent Prosecution Primer

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.

How to patent systems, software, and business method inventions: What have recent cases taught us?

Author

Richard Bone

Presentation

255th ACS National Meeting - New Orleans
"Update On Patent Eligibility: Are things getting better for Patent Applicants?"

Abstract

Alice in the Rear-View Mirror - Given the significant role that computer processes play in most areas of chemical research, the effects of the Alice decision are not confined to the high-tech industry. With now almost 4 years’ experience of post-Alice jurisprudence in the lower courts and application of the PTO’s “Alice rejections”, the speaker will review the key patterns that have emerged, with a particular focus on areas of computation that will be of interest to chemists.

MARCH 2018Katie
How to patent medical diagnostics and genetics related inventions: What have recent cases taught us?

Author

Jonathan L. Kennedy

Presentation

255th ACS National Meeting - New Orleans
"Update On Patent Eligibility: Are things getting better for Patent Applicants?"

Abstract

This presentation will provide a brief review of the landmark decisions from the United States Supreme Court that reshaped the patent eligibility framework, including, Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. v. CLS Bank Int’l and the two-prong test that developed from these cases.

This session program will review some of the more recent cases interpreting and applying the standards provided by the U.S. Supreme Court in its landmark decisions Mayo Collaborative Servs. v. Prometheus Labs., Inc.; Ass’n for Molecular Pathology v. Myriad Genetics, Inc.; and Alice Corp. v. CLS Bank Int’l  as they apply to medical diagnostics technology and other chemical technologies dealing with products of nature and genetic code. In practice how is the two-part patent eligibility test being applied and what can we learn from these cases to develop and claim patentable inventions in this technical art?

MARCH 2018Katie
Mayo, Alice, Prometheus, Enfish? What is the current test for determining if an invention is eligible for patent filing?

Author

Richard Bone
Jonathan L. Kennedy

Presentation

255th ACS National Meeting - New Orleans
"Update On Patent Eligibility: Are things getting better for Patent Applicants?"

Abstract

This presentation will provide a brief review of the landmark decisions from the United States Supreme Court that reshaped the patent eligibility framework, including, Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. v. CLS Bank Int’l and the two-prong test that developed from these cases.

MARCH 2018Katie
Issues in chemical commercialization

Author

Erin Sommers, erin.sommers@finnegan.com
Krista E. Bianco, krista.bianco@finnegan.com
Irene Hantman, ihantman@verdantlaw.com
Greg Sower, GSower@ramboll.com

Presentation

255th ACS National Meeting - New Orleans
"Issues in Chemical Commercialization"

Abstract

This program will address issues in chemical commercialization from regulatory compliance to Intellectual Property (IP) and contractual considerations. Participants will learn about the regulatory burden the Toxic Substance Control Act (TSCA) imposes on introducing chemicals into commerce from R&D to commercialization. Panelists will discuss protecting intellectual property through patents and EPA’s TSCA notification process. In addition, panelists will discuss contract provisions important to protecting inventors’ rights. Regulatory hurdles will be discussed as well. These include developing testing data for new chemicals and protecting confidential business information (CBI). TSCA does not require testing for new chemicals, however, failure to provide adequate toxicity testing can slow the EPA review process dramatically resulting in delayed access to market and unforeseen testing costs – testing can be designed to provide information for EPA review as well as REACH and GHS classifications. The Lautenberg amendments to TSCA have significantly restricted CBI claims in the US. Additionally, chemicals pursuing GRAS status for food uses will have to make safety information publicly available.

MARCH 2018Katie
Review of recent Federal Circuit decisions relevant to what scientists need to know about patent filing and prosecution

Author

Xavier Pillai, xpillai@leydig.com
Andrew Berks, aberks@cittonechinta.com

Presentation

255th ACS National Meeting - New Orleans
"Strengthening Your Patent Rights in Light of Recent Federal Circuit Court Decisions"

Abstract

Chemical and pharmaceutical companies invest enormous amounts of money and inventor hours to discover and develop new materials such as drugs and processes for making them, as well as other inventions. Such companies also attempt to protect their inventions by securing patents. The success of these inventions in the marketplace depends on a number of factors, the foremost of which being the strength of the patents obtained to protect them. These patents are expected to protect the vast investment of money and time in creating these inventions, and the product market share, for the next nearly twenty years.

However, competitors will try to undermine the value of the inventions by challenging the strength of the patents, including their validity and coverage by the patent claims of their own products, in a court of law.

Recently, many seemingly strong and valuable patents have been invalidated or narrowly viewed and found not infringed. Recent court decisions reinforce the axiom that every word that goes into describing the invention in a patent application must be chosen with extreme care. This session will provide insights into how to reduce the chances of losing in a patent battle against an infringer, including practical pointers on how to write winning patent applications. This session will also analyze recent Federal Circuit court decisions that have invalidated such patents or found them not infringed, as real world examples of what can go right or wrong years after a patent is granted.

MARCH 2018Katie
Practical Considerations for patent portfolio management

Author

Krista E. Bianco
Finnegan LLP

Presentation

254th ACS National Meeting - Washington, D.C.
"Intellectual Property Considerations When Entering into a Joint Venture"

Abstract

Portfolio management transforms raw innovation into monetized assets. These practical considerations will assist in that transformation - from prioritizing patent prosecution to integrating business and legal objectives - in order to establish or maintain your position in the marketplace.

AUGUST 2017Katie
Better together? How to avoid common pitfalls in joint ventures

Author

Charles Collins-Chase
Finnegan LLP

Presentation

254th ACS National Meeting - Washington, D.C.
"Intellectual Property Considerations When Entering into a Joint Venture"

Abstract

Renewable energy set records in 2015. Global investment in renewable energy rose 5% to $285.9 billion, exceeding the previous record set in 2011. Perhaps more impressive, roughly 134 GW of renewables were commissioned in 2015 (excluding large hydro). This investment and new capacity comes despite low oil prices that helped protect fossil fuels’ competitive market position.

In 2016 and 2017, these trends seemed to continue, with total renewable energy production in the United States exceeding 2015 levels, including in biofuels. Yet bringing renewable technologies to market is increasingly a capital-intensive process with many technical challenges. Projects are bigger than ever, and companies must overcome uncertain renewable fuel standards and government incentives and ongoing low oil prices. Faced with these challenges, many companies lack the resources and infrastructure to develop and implement renewable energy technology on the scale—and at the cost— the market demands. As a result, the biofuels industry has seen a rise in joint ventures and other collaborative relationships. For example, one study identified nearly 500 renewable energy partnership transactions announced between 2014 and 2015, of which 62% were joint ventures.

Although joint ventures can help companies overcome technological limitations, mitigate risks, and spread the costs of producing a product on a commercial scale, they also create potential pitfalls for companies with intellectual property assets. For example, a company may need to grant its joint venture partners a license to use its patented technologies or even share its trade secrets and other know-how with those partners, who may be industry competitors. Additionally, joint ventures can lead to development of new innovations, and disputes may arise as to who owns the resulting intellectual property and has the right to use it. This presentation will outline the potential perils of joint ventures for companies’ intellectual property portfolios and discuss strategies to protect their patents and trade secrets when entering these agreements.

AUGUST 2017Katie
Options for protecting your intellectual property and IP trends in renewable energy

Author

Matthew Hlinka
Finnegan LLP

Presentation

254th ACS National Meeting - Washington, D.C.
"Intellectual Property Considerations When Entering into a Joint Venture"

Abstract

The number of renewable and clean energy patents has increased dramatically over the last decade as global investment in those technologies continues to rise. This presentation will highlight the recent growth of renewable and clean energy patents. This presentation will also explore various options for protecting your intellectual property such as patents, trademarks, copyrights, and trade secrets and discuss how those distinct, but complementary, options can best be integrated to effectively protect your intellectual property.

AUGUST 2017Katie
Interplay between patent office postgrant challenges and district court patent infringement cases

Author

Justin J. Hasford
Erin M. Sommers

Finnegan LLP

Presentation

254th ACS National Meeting - Washington, D.C.
"Recent Developments Regarding Post-Grant Challenges at the United States Patent & Trademark Office"

Abstract

The America Invents Act provides inter partes review (IPR) and post-grant review proceedings (PGR) as means of challenging patents before the U.S. Patent and Trademark Office. Often challengers will attack patents simultaneously in IPR and PGR proceedings and in district court patent infringement cases. This presentation will explore the interplay between such challenges and discuss strategies for successfully defending patent rights against such attacks.

AUGUST 2017Katie
Recent developments in post-grant review preceedings

Author

Krista E. Bianco
Kassandra Officer

Finnegan LLP

Presentation

254th ACS National Meeting - Washington, D.C.
"Recent Developments Regarding Post-Grant Challenges at the United States Patent & Trademark Office"

Abstract

This presentation will examine recent decisions from the Patent Trial and Appeal Board and the Court of Appeals for the Federal Circuit concerning the obviousness analysis for chemical and pharmaceutical patents, defenses to post-grant review proceedings, and the scope of the estoppel provision, among other recent developments.

AUGUST 2017Katie