BIO IP Counsels Conference Agenda Topics

Posted under AIA, AIA implementation, American Invents Act, BIO, biosimilars, Blog, Companies, Diagnostics, Events, Funding, Intellectual Property, Intellectual Property Counsels' Committee, IPCC, Medical Devices, Medical Supply, Patently BIOtech, Pharmaceuticals, process patents, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

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.

Mass. Governor Patrick Looking Forward to the BIO International Convention

Posted under 2012 BIO International Convention, BIO, Blog, Boston, Companies, convention, Diagnostics, Events, Funding, massachusetts, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

In just six months, Boston will be welcoming more than 15,500 of the world’s leading biotech stakeholders to the biggest industry event of the year – the 2012 BIO International Convention.

Both Massachusetts Governor Deval Patrick and Boston Mayor Thomas Menino attended a kickoff breakfast in October where they voiced their industry support:

“It’s an honor to have BIO coming back so soon,” said Gov. Patrick. “By drawing the world’s attention once again to our state’s inherent strengths, we can and we will create both the immediate and long-term economic impacts that benefit businesses, workers and families across the Commonwealth.”

“Biotechnology is an industry that continues to grow and thrive here in Massachusetts,” said Boston Mayor Menino. “People are flocking to us, wondering, ‘What does Boston have?’ This is our chance to showcase everything that we have to offer to life sciences companies and to strengthen our success as a global leader.”

Annually, the convention attracts the biggest names in biotech, offers key networking and partnering opportunities and provides insights and inspiration on the major trends affecting the industry. It is the world’s largest conference devoted to the bustling intersection between commerce and the biotech industry, highlighting the many ways in which biotech continues to offer answers and hope for the world’s most pressing issues and provide high-quality, high-wage jobs.

2011: A Pivotal Year for Biotechnology

Posted under BIO, Blog, Companies, Corporate, Diagnostics, Funding, Jim's Corner, legislation, Medical Devices, Medical Supply, Pharmaceuticals, Public Policy, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world. Continued innovation will lead to breakthrough new and improved cures and treatments for patients living with debilitating diseases such as cancer, HIV/AIDS, diabetes and Parkinson’s; enhanced agricultural products to feed a growing global population while protecting the environmental health of our planet; vaccines to protect against bioterrorism; and revolutionary biofuels. The ability of BIO members to continue our shared mission to heal, fuel, and feed the world depends on having an economic and public policy environment that supports research and development that leads to continued innovation.

Read the full article on BIO.org

Report: Senate staffers hammering out accelerated drug approval pathway

Posted under BIO, Blog, Companies, Diagnostics, Drug approvals, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vemurafenib, Videos by John Carroll

BIO and Sen. Kay Hagan (D-NC) are working on draft legislation that would clear a shortcut through clinical trials straight through to the FDA for developers engaged in rare disease drug work, according to a report from Bloomberg.

Citing Senate aides involved in the legislative process, Bloomberg says BIO is angling to have the FDA's regulatory mandate tweaked to lay out the groundwork for marketing approval of a drug that meets an unmet medical need with just Phase II data. The agency has the authority to do just that, but rarely uses it. The new legislation would spell out the rules, mapping a clear path for developers who meet the criteria.

The FDA, of course, already offers orphan drug incentives, with developers able to get special tax breaks and a 7-year stretch on their market monopoly rights. The agency has also been discussing plans to speed up approvals for new drugs that promise exceptional results. In a certain sense, the recent accelerated approval for Roche and Plexxikon's melanoma drug vemurafenib illustrated the agency's willingness to step lively when it sees something particularly promising.

Nevertheless, a grumpy biotech industry has been complaining incessantly that regulators overall are far too slow to hit the green light on a drug. The regulatory hurdle has been cited repeatedly for being far too high for the venture groups that back drug developers. And new legislation that doesn't require extra federal dollars might be received warmly by lawmakers.

- here's the story from Bloomberg

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Roche wins early approval for blockbuster melanoma drug vemurafenib