BIO IP Counsels Conference Agenda Topics

Patently BIOtech

Join us in Austin for BIO’s Intellectual Property Counsels Committee Conference on April 16-18.  Agenda topics are below.

The Decline of Process Patents:

This session will examine the enforceability of process claims and how it has led to the recent controversy around divided infringement. Unlike claims to machines, manufactures, and compositions, process claims can be divided up by different actors, or by jurisdiction, and conceivably even by time.  Right now the focus is on different claim steps that are performed by different entities, where the law doesn’t provide a remedy for direct (and therefore indirect) infringement – a widening loophole in Section 271(a), (b), (c) and (f). We will discuss this issue and examine how it affected cases involving Abbott, Cardiac Pacemakers, McKesson and Centillion.

Patentability – The Writing on the Wall: Personalized Methods of Treatment and the Evolving “Printed Matter” Doctrine

In the U.S. Supreme Court appeal of Prometheus v. Mayo, a case dealing with the patent-eligibility of a biomarker-assisted treatment claim under Section 101, the United States have proposed an alternative theory of invalidity that may foreshadow the way the USPTO will treat claims that incorporate newly discovered biological correlations. This panel will discuss the government’s theory – an extension of the “printed matter” doctrine recently developed in King Pharmaceuticals v. Eon Labs – and explore how it can be extended to, distinguished from, or reconciled with the holding in Prometheus. The panelists will trace the development of the printed matter doctrine from its origins in cases involving simple labeled articles and board games to its recent implications for complex biomedical processes, and provide recommendations for in-house prosecutors.

The Regulatory Tide Is Coming In: FDA and Industry Get Ready for Biosimilars

This panel will provide an update on recently-issued FDA guidance, what’s happening in the industry, including updates on likely biosimilar applications, what’s next at FDA, FDA’s involvement in determining applicable dates for the 12-year data exclusivity period, how FDA will handle data packages, and reviewer access to originator BLAs for purposes of evaluating a biosimilar application.

The Coming Storm of Biosimilars Litigation

With the creation of the biosimilars litigation scheme and the recent enactment of the AIA, there will be many different avenues by which patents can be asserted and challenged.  If patent litigation were a chess game, this new world if chess on a 3-dimensional board.  This panel will discuss patent enforcement and challenges in federal court before, during and after a biosimilar application is considered by the FDA, including acts of artificial infringement under the BPCIA and the scope of the 271 (e)(1) safe harbor, as well as ITC actions and Patent Office proceedings.

AIA Implementation and Strategy

This session will survey the recent waves of PTO draft regulations implementing the America Invents Act and highlight important considerations for in-house practitioners in preparation for upcoming effective dates. Among other topics, an expert panel of in-house, USPTO, and law firm practitioners will discuss PTO draft regulations governing supplemental examination and the new opposition-type proceedings, the operation of the new “reasonable likelihood” threshold for inter partes reexam and inter partes review, demystifying the grace period for inventor disclosures, assignee filing under the AIA, a Primer on the new prior commercial user defense, and filing and disclosure strategies under the AIA.

Seeking Guidance: Updates on Federal Circuit Activity

Our panel will provide an update on recent patent cases from the Federal Circuit, including how the district courts have dealt with same issues in the wake of the Federal Circuit’s guidance. Particularly, the panel will focus on cases dealing with injunctions and patentability, and provide perspectives from in-house counsel, outside counsel, and academia. The panel will engage the audience in a hypothetical fact pattern applying the principles from one of the lines of cases presented.

**Updated Agenda.

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