The Showdown over Diagnostic Methods— Obtaining Patent Protection from the PTO under the AIA Despite the Supreme Court’s Nebulous View of a “Product of Nature”

January 23, 2014 4:30pm

Bruce S. Weintraub
Senior Corporate Counsel, Intellectual Property, Legal Division
Pfizer Inc.

Vineet Kohli
Intellectual Property Counsel
GE Healthcare

Christopher E. Jeffers Ph.D.
Mintz Levin Cohn Ferris Glovsky and Popeo PC

Not only has the AIA created great uncertainty as to how to proceed with obtaining patent protection, but the Supreme Court has issued rulings in Prometheus and Myriad that have left life sciences companies, hospitals, and universities looking at their patent portfolios with alarmed confusion. Research and development of diagnostic methods continued during the pendency of Myriad, and has continued since its issuance. This session explores the future effects of Prometheus/Myriad on diagnostic method patents, and offers advanced techniques in patent application drafting in order to gain patent protection from the PTO.

• Adjudicating patent validity at the PTO
– Deciding whether to forego the clear and convincing litigation standard in favor of the preponderance of the evidence standard in the PGR process
– Using reexamination as a tool to challenge or uphold a patent
– Factoring in collateral estoppel considerations for claims which should have been raised in the PGR process
– Using IPRs to clear freedom to operate in anticipation of a launch
• Exploring the confines of Prometheus and Myriad
– What methods are left unaffected by the rulings?
– What keywords, such as “isolated”, should be avoided in patent applications?
– Have patent examiners applied these rulings and, if so, how?
• Determining whether a higher concentration of a “naturally” occurring substance qualifies for patent protection
• Analyzing whether reverse engineering products of nature in a laboratory setting runs afoul of Prometheus/Myriad
• Avoiding the slippery slope—applying these and other patent drafting techniques to biosimilars and biologics in order to avoid a Myriad scenario
• Anticipating the interplay between complex patent resolution and new post-grant administrative patent validity proceedings (i.e., IPR, PGR, derivation proceedings, and supplemental re-exams)