BIO’s IP Priorities for 2011

As we start a new year, the BIO Intellectual Property Department has determined their 2011 priorities.  Intellectual Property remains a foundational priority for BIO and our 1100 biotechnology company members.

BIO’s IP department has approved the following priorities for 2011:

1) PTO reforms to improve efficient, timely and quality examination

2) Congressional patent reform legislation

3) Improving IP protection in key foreign markets

4) IP legal developments in the courts

5) Protecting the breadth and flexibility of the patent and technology transfer system.

Advertisements

Innovation Alliance Event “Patents, Innovation and Job Creation: A Virtuous Circle”

An event is coming up on patents, innovation and job creation at the Newseum on Friday January 21.  The keynote speakers are  PTO Director David Kappos and Retired Chief Judge of the Federal Circuit Paul Michel. 

Other industry experts and executives will participate in panel discussions.  Below is the news release.

As the U.S. economy struggles with high unemployment, the Innovation Alliance hosts a half-day discussion with inventors, entrepreneurs, business leaders, and industry experts on the economic value of patents and a vigorous USPTO. The conference features remarks from David Kappos, Director of the U.S. Patent and Trademark Office, and Paul Michel, U.S. Court of Appeals for the Federal Circuit, Retired Chief Judge. Gene Quinn, founder of IPWatchdog, Inc and Kim Hart, reporter at Politico will moderate morning panels on creating jobs and the impact of patents on the modern innovation economy. Email Innovation Alliance to RSVP

Here is the advertisement with further details.

AUTM’s 2010 Better World Report Highlights

 AUTM released their Better World Report for 2010 highlighting academic innovations commercially developed through technology transfer that are improving the quality of life.  Here is a quote from their press release.

A device that allows the blind to ―see‖ via electrical pulses applied to the tongue…a collagen scaffold to treat damaged joints…a new vaccine to prevent shingles…an artificial lung that provides patients with both mobility and comfort during treatment…a program that vastly improves literacy among middle and high-school age students…a device that transforms wheelchairs into all-terrain vehicles…a vaccine to prevent HPV…

These are just a few of the discoveries featured in the 2010 edition of the AUTM Better World Report, a collection of stories about technologies that originated in academic research and were brought to the public through technology transfer, the process of licensing and commercializing academic research so it can become real products that make the world a healthier and safer place.

Senator Birch Bayh writes the foreword and includes impressive evidence of Bayh-Dole’s success.

• More than 6,000 new U.S. companies were formed from university inventions.

• 4,350 new university licensed products are in the market.

• 5,000 active university-industry licenses are in effect, mostly with small companies.

• More than 153 new drugs, vaccines or in vitro devices have been commercialized from federally funded research since enactment of Bayh-Dole.

• Between 1996 and 2007 university patent licensing made:

❍ a $187 billion impact on the U.S. gross domestic product,

❍ a $457 billion impact on U.S. gross industrial output; and

❍ 279,000 new jobs in the United States.

A fairly impressive accomplishment considering before Bayh-Dole Senator Bayh states:

 “We found 28,000 government-funded inventions gathering dust on agency shelves with not a single drug commercialized when the government owned the patent.”

The report is an interesting read as it includes a small snapshot of what the academic and private sector can do when patent ownership incentives are properly aligned. 

 

USPTO Economic Research Agenda

The USPTO has a new Office of the Chief Economist and they have recently published their research agenda.

USPTO Economic Research Agenda

The OCE is embarking upon an aggressive economic research program to provide evidence on a range of matters relevant to policymaking and the effect of IP on economic outcomes more generally.  These include:

(1) Relating IP to economic growth, performance and employment, including:             

            (a)  IP and entrepreneurship                                 

            (b)  IP and wider economy-wide growth.                              

(2) IP in de facto standards, standard setting, and standards policy.

(3) Researching the economics of trademarks and trademark examination.

(4) Understanding the economics of USPTO initiatives, including initiatives to reduce application backlogs, by better understanding their costs, benefits, and effects.

(5) Analyzing the role that IP plays in the markets for technology and knowledge 

Report on a conference discussing the “Research Agenda”  at the University of California (09/10/2010)

For more specifics from the PTO website click here.

IPWatchdog.com interview of Bayh-Dole insider

A great article from IPWatchdog.com giving Joe Allen’s (a Birch Bayh staffer) insider perspective on the passage of the Bayh-Dole Act. 

The Article’s Introduction:

William Shakespeare once wrote:

There is a tide in the affairs of men
Which taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

See Julius Caesar.

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

Is the Myriad Case Decision and/or the DOJ Brief TRIPS Compliant?

Judge Sweet seemed to dismiss Myriad’s constitutional taking and TRIPS claims by indicating:

“Finally, Myriad’s suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States’ obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad’s novel taking argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly,Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property law and to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitution neither a constitutional violation nor a conflict with the Untied States’ treaty obligations.” Pages 106-107. Emphasis added.

Alnylam’s Appellate Brief to the Circuit Court in the Myriad case argues that “excluding certain “compositions of matter” from patent-eligibility would violate the United States’ treaty obligations under the TRIPS Agreement.” pg. 17  The Brief goes on to discuss this legal issue as well as international policy implications.  pg. 18-19

Questions for thought:

1.  Would ‘isolated DNA’ even constitute an “invention” under TRIPS Article 27.1?  How do other nations view patentability of ‘isolated DNA’ and how does that affect a TRIPS analysis? See European Union Biotechnology Directive and WIPO’s “Information provided by WIPO Member States Concerning Practices Related to the Protection of Biotechnology Inventions.”

According to practice, a Dispute Panel would use the ordinary meaning of the word (probably from the Oxford English Dictionary) and look at common practice around the world.  Isolated DNA seems to meet the definition of ‘invention’ and the resources mentioned above seem to back up the assertion. 

2.  What about Alnylam’s “discriminatory… as to the field of technology” argument?  Does Judge Sweet’s opinion discriminate against DNA based patents and/or the Biotechnology Industry?  How does the DOJ’s Brief fare? 

Based on a WTO Dispute Panel analysis on discrimiation in a similar context (see CANADA – PATENT PROTECTION OF PHARMACEUTICAL. PRODUCTS), it seems that both Judge Sweet and the DOJ Brief are discriminating against DNA based patents and the biotechnology industry.  Judge Sweet creates a patentability exemption for ‘isolated DNA’ and DNA based inventions (to an unknown point).  The DOJ seem to create a new ‘isolation’ test which implicates much more than ‘isolated DNA’.  Both approaches specifically target the biotechnology ‘field of technology’ and have devastating effects on the industry.

BIO’s Comments on proposed PTO Humanitarian Technologies and Licensing Through the Intellectual Property System

Here are the highlights from BIO’s recent submission on the proposed PTO “Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System.”  

Background:

1.  “BIO’s members also understand that problems with access to medicines and other biotechnology products in the developing world have very little to do with the patent system, and are generally caused by other factors outside the control of individual stakeholders, such as lack of adequate local manufacturing, delivery, public health and sanitation infrastructure, trade and tariff barriers, regulatory obstacles, lack of market incentives, inequitable local distribution and corruption, diversion of products to more lucrative markets, and a chronic underinvestment in public health, education and environmental conservation. In fact, access issues persist even in countries where there are no patents covering humanitarian products and technologies.”

 2.  “While the patent system cannot be a primary policy lever to address these complex questions above, BIO nonetheless believes that innovative businesses from all sectors of the U.S. economy, including the biotechnology industry, can help improve the lives of underprivileged populations in the developing world. Indeed, BIO member companies have long participated in specific access and licensing initiatives that have informed the policy choices of members of the industry.”  (See http://www.globalhealthprogress.org/, http://www.ifpma.org/healthpartnerships, http://www.bvgh.org/LinkClick.aspx?fileticket=867bPGw-kYo%3d&tabid=105, http://www.aatf-africa.org/, and http://www.cimmyt.org/.)

 “Most recently, in May of this year, BIO announced a policy statement containing its Options for Increasing Access to Medicines in the Developing World that it believes should be considered during the development and commercialization of biotechnology products.  Accordingly, BIO commends the USPTO for likewise exploring creative and market-oriented ways to incentivize the development and distribution of humanitarian technologies, a goal that BIO and its members have long shared and are working hard to achieve. In addition, BIO would support efforts to bring together all potential stakeholders to explore various approaches and initiatives.”

Key Points:

1.  Any program should be technology-neutral – “In BIO’s view, such a program should be applicable to innovators from all sectors who engage in the creation and dissemination of technology that has the potential to address the needs of impoverished populations in the developing world.”

 2.  Any proposal should ensure USPTO’s core mission is maintained and adequately resourced.

 3.  Value of any proposed vouchers should be maximized, but will remain limited – “BIO believes that the commercial value of the proposed voucher could be substantial under some situations, but difficult to express in monetary terms at this time.” 

4.  Clarity of standing for voucher use needed – “BIO members are seriously concerned that vouchers could potentially be used by third party requesters, or even unrelated third parties, to accelerate the ex parte reexamination of other party’s patents without the patentee’s consent.”

5.  Policy options for voucher award process require further discussion – “BIO members also raised the question whether the proposed vouchers should be awarded as an entitlement for meeting certain objective criteria, or as a more subjective prize for extraordinary humanitarian licensing efforts.”

Conclusion:

“BIO understands this Federal Register notice to be a first conceptual step in what will be a deliberative process with additional opportunities for public review and comment as more specific details and approaches are proposed. With this understanding, we look forward to engaging further on this effort in partnership with the USPTO and other industries and stakeholders.”

BIO’s Full Comment