Biotech Buzz, December 2012


Two Programs and a “Table Topic” Discussion at Mid-Winter Institute, Tampa, FL, January 31, 2013

Join us in Tampa Florida on the afternoon of January 31, 2013 for three hours of CLE that the Biotechnology and Chemical Practice Committees have jointly planned.

IP Value for Personalized Medicine

Health agencies, payers, patients, and biopharma companies are on the bandwagon for personalized medicine. In-house lawyers from a spectrum of entities involved in personalized medicine will provide views about the role and the value of IP for new products and services, with focus on tech transfer and licensing. They will also touch on the effects of recent cases. How do they affect deals? Can personalized medicine correlations be validly claimed? To what extent might research exemptions limit patent rights? Have divided infringement concerns been alleviated? When could inherency be an insurmountable hurdle? How to avoid European patent exceptions. Business people and in-house lawyers from a very diverse spectrum of entities involved in personalized medicine and diagnostics will provide views about the value of IP for the development of new products and services. 

Judy A. Roesler of Roesler Law Offices, PLLC in Cary, NC will moderate a panel featuring Manny Vacchiano, Lead Patent Counsel, Life Technologies; Yuko Soneoka, Senior Corporate Counsel IP, Genome Health, Inc.; Robert L. Sharp, Patent Counsel, Eli Lilly and Company; Natalie Wright Curley, Managing Director of the Office of Technology Commercialization, MD Anderson Cancer Center; and Jarett Rieger, Director and Associate General Counsel of the Office of Technology Mgmt & Commercialization, Moffitt Cancer Center and Research Institute.  Please join us for a lively and informative discussion with in-house counsel across a broad spectrum of players in personalized medicine.

Aligning IP Strategies with Business Objectives Up and Down the Supply Chain

How does a company’s position in a supply chain affect IP strategies? How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships? How do companies use IP to obtain value in the marketplace even when their businesses are not high tech? Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses. How does a company’s position in a supply chain affect IP strategies?  How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships?  How do companies use IP to obtain value in the marketplace even when their businesses might not be thought of as innovative? 

Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses.  Carol Nielsen of Nielsen IP Law LLC in Houston will moderate a panel consisting of Richard Phillips, Chief Attorney Technology, ExxonMobil Chemical; Patrick Bengtsson, VP, Assoc. GC, IP, The Clorox Company; Valerie L. Calloway, Chief IP Counsel, Polymer Group, Inc.; and Nancy M. Klembus, Assistant General Counsel, Kimberly-Clark, Corp

“Table Topic” Leaders Needed for MWI Lunch Discussions, Thursday, January 31

If you are planning to attend the MWI in Tampa on Thursday, January 31 please join the table talk lead team to lead table discussions following the luncheon keynote address by Ford’s Bill Coughlin.  Thanks to the members who have already volunteered: Dave Cupar, Robin Chadwick, Brian Stanton, Timothy Meigs, Greg Lavorgna, Katherine Dover, Debora Plehn-Dujowich, Daniel Monaco, Roy Isaac, Dianne Elderkin, Valerie Calloway, and Brooke Schumm.

We could use a few more leaders.  Let Debora Plehn-Dujowich of Drinker Biddle know of your interest.


Patentability of Diagnostic Methods and Biomarkers: A European Perspective – Slides and Recording Available

On December 18th, the Biotech Committee presented a dynamic and highly informative webinar titled “Patentability of Diagnostic Methods and Biomarkers: A European Perspective.”  The panelists were Oliver Kingsbury from Elkington and Fife, Russell Thom from Murgitroyd & Company, and Ana Suarez-Miles from Eli Lilly.  Debora Plehn-Dujowich moderated. 


Slides and a recording of the webinar are available. 


We thank Elkington and Fife and Murgitroyd & Company for sponsoring the webinar.

Reprise of Annual Meeting Presentations, TBD

The speakers at our Annual Meeting, discussed above, will reprise their presentations in a webinar on a date yet to be determined.  The presentations relate to antibody patenting in the US and Europe and novel venture financing for biotechs. 

Case Law Reports

Case Law Report Link

ButamaxTM Advanced Biofuels LLC, et al. v. E.I. Dupont de Nemours & Co., reported by Julia Kim.

Case No. 2012–1490 (Fed. Cir. Nov. 16, 2012) (affirming denial of preliminary injunction for patent related to biofuels because defendant raised a substantial question of validity). 

Petition to the Secretary of Health and Human Services to “March In” Against the Ritonavir Patents, reported by Nicholas Landau, Ph.D., Bradley Arant Boult Cummings, Birmingham, AL.

(Oct. 25, 2012) (PIRG petition the U.S. government to exercise its “march in” rights and force Abbott to grant a compulsory license to AIDS drug). 

PerkinElmer, Inc. v. Intema, Ltd., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN.

Case No. 2011-1577 (Fed. Cir. Nov. 20, 2012) (holding claims to method of diagnosing Down’s syndrome invalid under 35 U.S.C. §101 as not being directed to patentable subject matter). 

International Issues

Oh Canada! – So Promising, So Invalid

Reported by Daphne C. Lainson, Smart & Biggar, Ottawa, Ontario, Canada

There has been some continuing litigation following the Canadian Supreme Court’s finding that the sildenafil (the active ingredient in VIAGRA®) second medical use patent was void for insufficiency of disclosure (lack of utility).  A complete summary of the Canadian Supreme Court’s opinion was published in the November 2012 Biotech Buzz

Utility continues to be a common and unusual ground of invalidation of patents that cover marketed pharmaceutical products.  Eli Lilly and Company’s method of use patent covering its STRATTERA® product was invalidated on the basis of failing to meet Canada’s unique, judge-made utility requirements.  On November 7, 2012, Eli Lilly and Company served the government of Canada notice of intent to submit a claim to arbitration under Chapter 11 of the North American Free Trade Agreement in relation to the invalidation.  Lilly’s notice and the presentations and papers from a Comparative Law Symposium held in Ottawa, ON, CA on 4 April, 2012 are worth reading if you draft or prosecute applications with hopes to obtain valid protection in Canada.

CJEU Rules Against AstraZeneca in Abuse of Dominant Position Appeal (SPCs and Anti-Competition Law)

Reported by René John Raggers, EP&C, Utrecht, The Netherlands

On 6 December 2012, the Court of Justice of the European Union dismissed an appeal by AstraZeneca (AZ) against the General Court, which held that AZ had abused its dominant position with respect to its anti-ulcer drug, Losec. 

Regarding abuse of a dominant position concerning supplementary protection certificates (SPCs), the Court concludes that the General Court was fully entitled to hold that AZ’s consistent and linear conduct was a breach of competition on the merits and therefore an abuse of a dominant position.  Specifically, the General Court found that AZ’s conduct was characterized by submitting misleading representations to the patent offices and a lack of transparency by which AZ deliberately attempted to lead the patent offices and judicial authorities into error in order to keep its monopoly on the medicinal products market for as long as possible.

The judgment and the court’s press release provide additional insights into the dismissal.

Brüstle v. Greenpeace, German Federal Supreme Court, 27 November 2012, Case no. X ZR 58/07 (Neural Precursor Cell Patent Partially Invalidated).

Reported by Paul von Dongen, NautaDutilh N.V., Amsterdam, The Netherlands

On November 27, 2012, the German Federal Supreme Court (Bundesgerichtshof) ruled on the validity of the patent of Oliver Brüstle, relating to neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects.  This invention could potentially play an important role in the treatment of diseases like Parkinson’s Disease and Multiple Sclerosis.

The European Patent Office granted the patent in 1999.  Greenpeace filed an action for annulment, arguing that the patent would violate public policy and accepted principles of morality because it relates to cells which could only be obtained by the destruction of human embryos.  The Federal Patent Court invalidated the patent for this reason.  The case went up to the Supreme Court which referred several questions to the Court of Justice of the European Union (“CJEU”).  In its decision of October 18, 2011 (Case C-34/10, Brüstle v. Greenpeace) the CJEU clarified that the prohibition to patent in case of the use of human embryos also applies if the patent relates to products for which the destruction of human embryos is necessary, even when the patent does not relates to the use of human embryos as such.

In this decision, the German Supreme Court follows the reasoning of the CJEU.  However, contrary to the Patent Court, the Supreme Court does not completely invalidate the patent.  The Supreme Court rules that the patent is valid to the extent the cells are produced without the destruction of human embryos.

The full reasoning of the Supreme Court is not yet published. See a press release regarding the judgment (in German).

Plant Biotechnology Subcommittee

Standard Material Transfer Agreement is the Gateway to the Multilateral System Under the International Treaty on Plant Genetic Resources for Food and Agriculture

The Plant Biotechnology Subcommittee was established this past July with a mission to foster awareness of key intellectual property issues that influence innovative plant research.  One institution already shaping the generation and dissemination of knowledge in the field of plant research is the Multilateral System (MLS) implemented under the International Treaty on Plant Genetic Resources for Food and Agriculture (IT PGRFA).  Under the MLS, member states agree to make the genetic diversity of the germplasm stored in their seed banks available to all in exchange for free access to commercialized products for further breeding and research (or royalty payments in lieu of free access).

The Standard Material Transfer Agreement (STMA) stands as the gateway to the MLS.  The SMTA is, in all important aspects, a non-negotiable instrument that must be executed by any party wishing to provide or receive seed under the MLS.  Under the SMTA, a recipient agrees to limit its use of transferred material to research, breeding, and training for food and agriculture, excluding any non-food or non-feed industrial purposes.  The SMTA also prohibits a recipient from seeking any intellectual property rights that may limit further access to the materials as received via the MLS.  Where the recipient conserves material received under the SMTA, it is further obligated to make such conserved material further available under another SMTA.  The SMTA further obligates the recipient to share all “non-confidential” information related to research and development using the transferred material.

The MLS and SMTA have been lauded as the first practical implementation of the fair sharing of benefits arising from the use of plant genetic resources.  However, benefit sharing under the SMTA is only triggered when a recipient commercializes a product derived from the transferred material.  Given its significance to the potential creation of any benefit that could be shared under the MLS, there remains a  surprising lack of commentary on what the SMTA means for those parties most likely to commercialize products, i.e. innovative plant biotechnology companies. 

Interestingly, of the more than 3500 shipments under the SMTA that have been disclosed by the International Rice Research Institute in the Philippines, only a handful of transfers have involved corporate recipients.  Does such anecdotal evidence illustrate a general mistrust of the SMTA on the part of corporate innovators and a corresponding reluctance to buy in to the MLS?  In a series of articles over the coming months, the Subcommittee shall seek to educate the membership on the SMTA and explore the issues that are most likely to present stumbling blocks to the wide embrace of the MLS by corporate innovators.  The Subcommittee further welcomes any contributions or comments from the membership in regards to issues they would like to see addressed.

USPTO Subcommittee

Combined TC3700 Medical Devices and TC1600 BioTech Customer Partnership Meeting, January 29, 2013 – NOTE WEBEX OPTION!

The upcoming USPTO Partnership Meeting in the Madison Auditorium in Alexandria, VA on January 29, 2013 will focus on the medical device industry, including diagnostics.  The purpose of the meeting is to bring industry stakeholders and patent examiners and directors from Technology Center 3700 (TC 3700) together to share ideas, experiences, and insights on best practices in advancing prosecution and provide a forum for discussing how the agency can improve and expand its relationship with the medical device technology community. 

Note: For the first time, you can participate via WEBEX.  More information and a link to registration (with WebEx option) can be found here.










Section 101 Issues


Lunch Break


AIA Update




Round table discussions


If you would like to present a topic or would like to suggest a topic for future meetings contact the customer partnership team.

Happy Hour, January 29, 2013

Join Biotech members for a Happy Hour at the Trademark Bar in the Westin Alexandria, 2080 Jamieson Ave., 400 Courthouse Square, Alexandria, VA 22314 (just a couple blocks west of the USPTO) after the BCP Partnership meeting.


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