Effective Intellectual Property Asset Protection for Biotechnology and Biopharmaceutical Facing Subject Matter Eligibility Challenges in 2016
From the outset, the biotechnology industry has relied upon the patent system to encourage the discovery and development of many innovative products and methods. Recent developments such as bio-markers, companion diagnostics and autologous cell therapies are transforming the treatment of many serious diseases. These advances in biotechnology and pharmacology are expensive and best protected by patents.
However, in the last few years, the United States Supreme Court has limited and reduced the value of biotechnological patents. Recent rulings of the U.S Supreme Court in Mayo v. Prometheus, Assn. for Molecular Pathology v. Myriad Genetics, and Alice Corp. v. CLS Bank have put the biotechnological and biopharmaceutical industries in an uncertain position with the USPTO.
The US judiciary has become increasingly active in defining patent law, and in some instances obscuring the legal intent of Congress. Regarding subject matter eligibility, the only recourse may be to reply upon Congress to revise Section 101 and more clearly define the statutory Subject Matter Eligible for patenting. If Congress allows the courts to more narrowly define subject matter eligibility, some innovations may suffer from inadequate patent protection.
In a two hour, LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will discuss the significant and latest ways to ensure Effective Intellectual Property Asset Protection for Biotechnology and Biopharmaceutical Facing Subject Matter Eligibility Challenges in 2016. The panel of speakers will review the latest cases and offer sound, practical advice in defining the scope of material for protection.
Some of the major topics that will be covered in this course are:
- New Interim Guidance on Patent Subject Matter Eligibility
- IP Protection Strategies
- Prosecution Strategies for Pending Claims
- Drafting New Applications
- Recent Supreme Court Decisions
- Mayo Collaborative Servs. v. Prometheus Labs., Inc.
- Assn. for Molecular Pathology v. Myriad Genetics
- Alice Corp. v. CLS Bank Int'l
- Claims in a Post-Mayo and Post- Myriad Environment
- Litigation Risks
- IP Asset Strategies for Clients
MaryAnne Armstrong, Ph.D., Partner
Birch Stewart Kolasch & Birch, LLP
- Where do things stand in terms of patent eligible subject matter since the CAFC Ariosa decision?
- The changing 101 landscape – Myriad, Mayo and the PTO
- What have we seen practically with regard to the application of the Interim Guidelines by the examiners?
- What are some strategies for overcoming 101 rejections?
Alan Craig Townsley, Ph.D., Attorney
Sughrue Mion PLLC
- Assessing the (enforceable) coverage of your existing patent portfolio
- Reissue applications to address patent-eligibility concerns with issued patents
- Continuation practice to cure defects in pending families / getting past 101 at the USPTO
- Drafting strategies to make applications future-proof
William Pagán, Attorney
Coats & Bennett, PLLC
Theme: Strategies for arguing against challenges under §101
- Common thread in modern §101 challenges: Claim is not grounded in anything identifiably physical (i.e., claims are disembodied and/or entirely internalized)
- Arguing to “machine or transformation” standard still effective
- Strategy 1: Argue that the claim requires a particular machine to implement the claim elements
- Strategy 2: Argue that the claim elements transform operation of the machine implementing elements in a tangible and significant way
- Strategy 3: Deemphasize effect of laws of nature
- Strategy 4: Tie calculations, internal algorithms/signaling to external physical consequences
Who Should Attend:
- Biotech/BioPharma Industry Lawyers
- Biotech/Pharma/Healthcare Attorneys & Advisors
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Biopharmaceutical Firms
- IP Attorneys & Consultants
- Patent attorneys
- Patent Licensing Attorneys
- Other Related and Interested Professionals
MaryAnne Armstrong is a partner with the law firm Birch, Stewart, Kolasch & Birch, LLP. She has a Ph.D. in biochemistry and master's degree in immunology. Dr. Armstrong works with large and small companies and universities for the preparation and prosecution of patent applications in the fields of immunology, pharmaceutical chemistry, biochemistry, organic chemistry, assay and drug screening systems, medical devices, and plant patents. Dr. Armstrong has considerable experience in counseling clients with regard to FTO opinions, based on infringement and/or validity analysis, as well as counseling clients with regard to patentability analyses and the preparation of license agreements and collaboration agreements. She is also experienced in FDA related procedures, including ANDAs and requests for Patent Term Extension.
MaryAnne Armstrong is a partner with the law firm Birch, Stewart, Kolasch & Birch, LLP. She has a Ph.D. in …
Dr. Alan Craig Townsley is an associate at Sughrue Mion, PLLC, and works out of their Washington, D.C., office. Dr. Townsley’s practice focuses on biotechnology, and includes patent procurement, client counselling, and patent portfolio management. Dr. Townsley’s practice also includes due diligence and opinion work, including the drafting of patentability, freedom-to-operate, and invalidity opinions. Dr. Townsley received his J.D. from The George Washington University Law School. He received his undergraduate degree in medical microbiology from The University of Edinburgh, United Kingdom. He also received his Ph.D. degree in molecular virology and immunology from The University of Edinburgh, for the study of gamma-herpesvirus-mediated immunoregulation. Prior to joining Sughrue Mion, Dr. Townsley was a post-doctoral research fellow at the National Institutes of Health, Bethesda, MD, within the laboratory of Dr. Bernard Moss in the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Townsley’s post-doctoral research focused on poxvirus cell-entry mechanisms.
Dr. Alan Craig Townsley is an associate at Sughrue Mion, PLLC, and works out of their Washington, D.C., office. Dr. …
William G. Pagán is a patent attorney, nationally-recognized and award-winning engineer, tech-industry veteran, and former IBM Master Inventor. His law practice is focused on patent preparation and prosecution, with a technical orientation towards software, computing devices, systems management, and telecommunications. Other technical areas of his patent practice include medical devices and industrial machines. Will started his practice at the intellectual property law firm Coats & Bennett after nearly 15 years of computer hardware and software engineering experience at IBM, where his inventions added over 120 patent applications to IBM’s portfolio. He graduated summa cum laude from NCCU Law as Valedictorian of their evening program, and also holds Masters and Bachelor's Degrees in Computer Science.
William G. Pagán is a patent attorney, nationally-recognized and award-winning engineer, tech-industry veteran, and former IBM Master Inventor. His law …
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About Birch Stewart Kolasch & Birch, LLP
Birch, Stewart, Kolasch and Birch, LLP (BSKB) is a full service intellectual property law firm, offering services in the areas of patent prosecution, post-grant review, litigation, ITC litigation, opinions and counseling, design patents, trademarks and licensing. Our knowledgeable attorneys and agents hold advanced degrees and are experienced in the fields of chemistry, electronics and IT, mechanical engineering and life sciences/biotechnology.
We believe in offering every client quality, personalized service, and are committed to educating our clients to help them make the most of their intellectual property. BSKB has a rich tradition of offering seminars on intellectual property law that have been attended by practitioners from around the world.
About Sughrue Mion PLLC
For over 50 years Sughrue Mion PLLC has protected the universe of ideas by providing strategic counseling to clients in obtaining, maintaining and capitalizing on their intellectual property. When litigation is unavoidable Sughrue’s experienced trial attorneys obtain results that further its clients’ business objectives. Sughrue lawyers have particular expertise before the International Trade Commission and extensive experience in all matters before the U.S. Patent and Trademark Office, Federal and state trial courts and the U.S. Courts of Appeal. A recognized leader in intellectual property law, Sughrue has obtained more U.S. patents for clients than any other firm in the world and is consistently ranked among the top U.S. firms annually for the number of issued U.S. patents and trademarks.
About Coats & Bennett, PLLC
Established in 1987, Coats + Bennett, PLLC is one of North Carolina’s oldest patent-focused law firms. Their team of approximately 15 patent attorneys and agents has extensive patent preparation and prosecution experience, particularly in the electrical, mechanical, and software arts across a broad range of technologies and businesses. Located in North Carolina’s “Research Triangle,” Coats + Bennett is a full service intellectual property law firm, practicing in patents, trademarks, copyrights, trade secrets, licensing, intellectual property litigation, and Internet and domain name disputes.