Come join in my panel discussions at LES and BioEurope!

At the annual LES meeting, on Tuesday Oct 21^st, 2-3:15pm, I’m moderating a panel on the different perspectives of business development in big versus small companies.   A3-HEA-11: BIG versus Small: What Can Be Learned from Switching Sides.  It should be a candid and lively discussion that just might help you understand how to deal with the other side. 

At BioEurope, Monday November 17^th at 9-10:30am, I’m joining a panel moderated by John Freshley on Using Translational Medicine to Optimize Your Out-Licensing Deal.  As big pharma increasingly integrates biomarkers and translational medicine into drug development, the types of data that drive value in licensing deals is changing.  We’ll try to be enlightening. 

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When must you take a license to IP on Research Tools under the Hatch-Waxman Safe Harbor?

More licenses may once again be negotiated for IP on research tools, but all is not clear. 

Under the Safe Harbor of the Hatch Waxman Act, it is not an act of patent infringement to make, use, or sell a patented invention solely for uses reasonably related to FDA submissions. In the 2005 Merck v. Integra decision, the Supreme Court held that the exemption applied to patented peptides used as research tools in preclinical drug discovery toward an FDA submission.  This decision rocked the world of licensing for patented research tools.   

Previously, the Court also decided that the Safe Harbor applied to devices as well as drugs, and the information gained from the research tool invention (such as preclinical research to establish biological effects) that was not seen by the FDA as part of the submission was still protected under the Safe Harbor. 

Now, a US Federal Circuit Appeals Court decision (Proveris Scientific vs. Innovasystems) seems to have narrowed (but not entirely clarified) the Safe Harbor provisions of the Hatch Waxman Act.  Proveris owns a patent on an apparatus for characterizing aerosol sprays in drug delivery devices.  Innovasystems, in defending itself against charges of patent infringement, invoked the Safe Harbor provisions, noting its spray analyzer is used by third parties in development and submission of information to the FDA.   Here the Court decided that, because the spray analyzer of Innovasystems is not subject to market approval, it faces no regulatory barriers to market entry upon patent expiration, and therefore is not what the Safe Harbor provision is designed to protect.  (Nature Reviews Drug Discovery 7: 722, September 2008). 

The decision changes the focus from whether the defendant’s infringing use of the patented invention is reasonably related to developing the types of information relevant to the FDA, to whether the defendant intends to seek FDA approval on the patented invention.  For example, the infringing use of a monoclonal antibody may be outside the scope of the safe harbor if it is used only as a research tool to isolate a subset of cells, but may fall within the safe harbor if the same antibody becomes a candidate for a therapeutic drug.  But at what stage is it a candidate for FDA approval and how do you judge the IP holder’s intentions for drug approval?  Integra’s peptides were not submitted for regulatory approval, but were used by Merck as research reagents (positive controls, etc) toward Merck’s drug approval.   

It is not yet completely clear when the use of research tools is given a Safe Harbor.  Licensing values for research tools will remain in flux.    

 http://holmansbiotechipblog.blogspot.com/2008/08/federal-circuit-interprets-271e1.html , http://www.wsgr.com/wsgr/Display.aspx?SectionName=publications/PDFSearch/clientalert_research_tools.htm, http://www.foleyhoag.com/NewsCenter/Publications/Alerts/Life-Sciences-Alerts/Life-Sciences-Alert-080608.aspx

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What is enough to describe the application of gene sequence patents? 

A UK court case between Eli Lilly and Human Genome Sciences found that just listing a wide-ranging list of possible industrial applications for a gene sequence does not meet the standards needed for a valid patent.  Because of the wide range and sometimes contradictory list of activities listed without biological data, the Court decided that the uses were only speculations.    A description must disclose a practical way to exploit the invention. 

So, HGS will lose the patent and Lilly can move forward with its Neurokine antibody program.  Other gene sequence patents based on genomics without biology data are likely to be challenged against this new threshold test.   http://www.scripnews.com/news/english-court-invalidates-hgsrsquos-gene-sequencing-patent-165 , http://www.managingip.com/Article/1990525/UK-Judge-issues-biotech-patent-principles.html

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Pullan Consulting

Linda M. Pullan, Ph.D.

Biotech Business Development

www.pullanconsulting.com and www.lindapullan.com

e-mail: lpullan@msn.com

805-558-0361

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