Author

Shana K. Cyr, Finnegan, Reston, VA
shana.cyr@finnegan.com
Megan Meyers, Finnegan, Atlanta, GA

Presentation

257th ACS National Meeting - Orlando
Tuesday, April 2, 2019, 10:30am-11:00am
Orange County Convention Center Room W308D
”Trade secret strategies for pharmaceutical innovations”

Abstract

Trade secrets can be a useful alternative to patents when seeking to protect certain pharmaceutical innovations. This presentation will provide a brief overview of trade secret law and give insights into identifying technology suitable for trade secret protection, safeguarding and enforcing trade secrets, and using trade secrets as part of a coordinated intellectual property strategy.

Author

David Weingarten, Finnegan Henderson, Atlanta, GA
M.David.Weingarten@finnegan.com
Katherine Leonard, Finnegan Henderson, Atlanta, GA

Presentation

257th ACS National Meeting - Orlando
Tuesday, April 2, 2019, 10:30am-11:00am
Orange County Convention Center Room W308D
”Post-grant review in Hatch-Waxman litigation”

Abstract

The America Invents Act (AIA) made sweeping changes to the U.S. patent system, including the creation of administrative trial procedures to request review of the patentability of issued patents outside of patent litigation in federal court. Competitors in the pharmaceutical industry have used post-grant review proceedings, such as inter partes review (IPR), before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board to challenge pharmaceutical companies’ patents as an alternative to litigation in federal court. This presentation will provide an overview of post-grant review proceedings, discuss the interplay between such challenges and patent infringement cases, and provide helpful strategies for pharmaceutical companies anticipating concurrent Hatch-Waxman litigation and post-grant review.

Author

Shana K. Cyr, Finnegan, Reston, VA
shana.cyr@finnegan.com

Presentation

257th ACS National Meeting - Orlando
Tuesday, April 2, 2019, 10:00am-10:30am
Orange County Convention Center Room W308D
”Patent litigation under the Hatch-Waxman Act”

Abstract

Whoever without authority makes, uses, offers to sell, sells, or imports into the United States any patented invention infringes the corresponding patent. Pharmaceutical companies generally enforce their patents by filing suit against competitors attempting to copy the innovator’s drug product in federal district court under the provisions of the Hatch-Waxman Act. This presentation will discuss the framework of pharmaceutical patent litigation under the Hatch-Waxman Act, including the patent listing requirements, FDA’s Orange Book, paragraph IV certifications, and the availability of a 30-month regulatory stay.

Author

David Weingarten, Finnegan Henderson, Atlanta, GA
M.David.Weingarten@finnegan.com

Presentation

257th ACS National Meeting - Orlando
Tuesday, April 2, 2019, 9:30am-10:00am
Orange County Convention Center Room W308D
”Patent prosecution and portfolio management in the pharmaceutical industry”

Abstract

Pharmaceutical companies maintain a complex patent portfolio aimed at attracting investors and protecting their place in the marketplace. Companies often pursue patent claims for their active ingredients, formulations, and methods of treatment, and strategically align patent filings with their business goals and development of their drug products. This presentation will provide a brief overview of U.S. patent law and give insights into building a valuable patent portfolio. The presentation will also discuss how to best avoid inadvertently forfeiting patent rights, how to draft effective claims, and how to decide when and where to file for patent protection.

Author

James Carver, The Carver Law Firm, LLC, Baton Rouge, LA
ACS-Carver@thecarverlawfirm.com,
Sofia Santos, Finnegan LLP, Boston, MA
sofia.santos@finnegan.com
Krista E. Bianco, Finnegan LLP, Washington, DC
rista.bianco@finnegan.com
Katherine Lavoie, The Boston Consulting Group, Boston, MA
klavoie89@gmail.com,
Judy Cohen, Particle Sciences Inc., Bethlehem, PA
JCohen@particlesciences.com

Presentation

257th ACS National Meeting - Orlando
Monday, April 1, 2019, 2:00pm-4:00pm
Orange County Convention Center Room W308D
”Beyond the bench: Non-traditional careers in chemistry”

Abstract

When you hear the word chemist, you may think bench chemistry and researcher. But being a chemist prepares you for much more than just a laboratory career. Chemistry is an art where analytical thinking, problem solving, research methodology and many other skills are learned and crafted. Those skills are highly valuable in many places outside of the laboratory. In fact, many chemists go on to have careers in a wide variety of industries and types of positions. This symposium is focused on just that. We will have a variety of chemists who have pursued non-traditional careers, i.e., careers outside of typical academic or industry research. We will discuss what their backgrounds are, what their current jobs are, how they came to choose their current careers, and how their background in chemistry provides skills useful for their current careers. The panelists have careers in the areas of business, law and legal support, press, and other areas. The speakers will each provide a brief synopsis of what they do and how they got where they are followed by open question and answers with the audience. If have considered a career outside of the laboratory or are simply interested in what other chemists have gone on to do in non-traditional careers, you won’t want to miss this symposium.

Author

Katherine A. Rubino, Caldwell Intellectual Property Law, Boston, MA
katie@caldwellip.com

Presentation

257th ACS National Meeting - Orlando
Monday, April 1, 2019, 11:15am-11:55am
Orange County Convention Center Room W308D
Post-grant proceedings of bio & pharma patents: A brief overview and analysis of noteworthy cases since implementation of the America Invents Act

Abstract

Inter-partes review has become an increasingly popular way to challenge patents, accounting for 92% of all post-grant trials. Inter-partes review was implemented in 2011 as part of the America Invents Act as an alternative to challenge patents in court. Since implementation, bio & pharma patents have been increasingly subjected to these petitions. Discussed in this presentation will be an overview of different strategies behind challenging patents in this way. We will examine the legal implications and considerations when implementing these challenges utilizing recent case studies. In addition, we will discuss strategies for patent holders.

Author

Katherine A. Rubino, Caldwell Intellectual Property Law, Boston, MA
katie@caldwellip.com

Presentation

257th ACS National Meeting - Orlando
Monday, April 1, 2019, 10:45am-11:15am
Orange County Convention Center Room W308D
”Strategies for monetization of patent portfolios in chemical fields”

Abstract

More than 3 million patent applications were filed in 2016, an 8.3% increase from 2015. As the number of patents filed worldwide continues to increase, creating a value driven patent portfolio is of utmost importance to maintain a position in the marketplace. Discussed in this presentation will be tips and strategies for monetization of biotech, pharma and life science patents. We will also examine approaches to develop a robust patent portfolio that can be treated as an asset class in and of itself.

Author

Adam M. Kiefer, Chemistry Dept., Mercer University, Macon, GA
kiefer_am@mercer.edu

Monica Silva González, Ministerio del Ambiente, Lima, Peru
Caryn S. Seney, Mercer University
Keegan H. Moody, Mercer University
Kazi Hasan, Mercer University
Victoria Blakeman, Mercer University
Lillian Hicks, Mercer University
Danielle Loving, Mercer University
Sumeja Aljic, Mercer University
Craig McMahan, Mercer University
Matthew E. Moore, Mercer University

Presentation

257th ACS National Meeting - Orlando
Monday, April 1, 2019, 10:00am-10:45am
Orange County Convention Center Room W308D
"Monitoring Hg emissions from gold shops in Peru: Science vs policy”

Abstract

Artisanal and Small-scale Gold Mining (ASGM) activities in Madre de Dios, Peru have resulted in widespread deforestation and environmental contamination with mercury. Amalgamation of gold ore concentrated on sluice boxes and the subsequent heating of the amalgam to isolate sponge gold releases large quantities of Hg° into the atmosphere. This problem is compounded by the fact that gold buyers in the region are often located in populated residential areas, burn the amalgams and reheat the sponge gold, releasing mercury vapor directly into the air at street level. For compliance with the Minamata Convention, monitoring and estimation of Hg emissions is essential. Peru requested the assistance of Mercer University to perform a preliminary assessment to quantify Hg emissions in ASGM areas. As a result, a study was organized to preliminarily quantify Hg emissions from gold shops. During October of 2017 and May of 2018, the location of gold shops and point sources of Hg° contamination throughout the city of Laberinto were mapped using a Lumex RA-915M AAS coupled with a GPS unit. The Peruvian standard norm establishes that total gaseous mercury (TGM) concentrations do not exceed an average of 2,000 ng/m3 over 24 hours. However, concentrations of Hg° in and around these gold shops often exceeded 2,000,000 ng/m3. While these concentrations far exceed the national air quality standard for total gaseous mercury (TGM) in Peru, the spectrometer used to measure these concentrations only monitors Hg° - one component of TGM. Because the standard norm requires TGM measurements, the data collected cannot be used for assessment purposes. The findings of the present study demonstrate 1) the need for a more specific environmental assessment of ASGM communities based on Hg° vapor as opposed to TGM and 2) the need for development of a correction factor for Hg° measurements to estimate TGM. Currently, protocols are being developed to define guidelines for monitoring airborne Hg concentrations throughout Peru including ASGM areas.

Author

Xavier Pillai
Leydig Voit Mayer Ltd, Chicago, IL
xpillai@leydig.com

Presentation

257th ACS National Meeting - Orlando
Sunday, March 31, 2019, 2:00PM-3:30PM
Orange County Convention Center Room W308D
"Strengthening your future patent rights in light of recent Federal Circuit court and USPTO 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. 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 and Patent Trial and Appeal Board 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 battle against an infringer, including practical pointers on how to write winning patent applications.

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.

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.

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?