Thursday, February 10, 2011

The Stanford Daily opines on policy issues with stem cell patents

Note the article in the Stanford Daily titled Unclear patent policies make future of stem cell research murky. One notes the words "unclear" and "murky" appear only in the title of the article, not in the body. Within the text, one finds the old platitudes about patenting holding up publishing.

With Thompson’s patents set to expire in the near future, competition within the field of stem cell research will begin to heat up. While Scott holds that greater competition is a good thing, Byers predicts a less sunny outcome, one that is already evident as the field expands into studying new types of stem cells. He speculates that because the field is so crowded and competition for patents is so high, researchers might stall the process of peer reviewing papers so they can first claim their own patents.
“It’s been almost exponentially more difficult to get a stem cell paper out in the last year and especially around differentiation of embryonic stem cells,” Byers said.
Clear and consistent policies for stem cell patentability have yet to be set. As the debate continues, Scott said, the tension lies between creating a competitive market within an intellectual framework versus having a monopoly on the technology.

For a different view:

Lawrence B. Ebert, What the Story of the Invention of the
Transistor Teaches Us About 21st Century Patent Practice,
8 J. MARSHALL REV. INTELL. PROP. L. 80 (2008).

***A comment by LBE to the Stanford Daily on Feb. 10, 2011 was not published

Although the Stanford Daily did not publish a comment by LBE on the above article (LBE is a Stanford alum), LBE/IPBiz do
publish a comment by Alan Regenberg of the Hinxton group.

Alan does have a New Jersey connection [Alan completed his undergraduate training in History and Psychology at Rutgers University, and received his Master of Bioethics degree from the Center for Bioethics at the University of Pennsylvania. ] but does not seem to be either technically or legally trained.

[ Alan Regenberg, MBe
Bioethics Research Manager, Johns Hopkins Berman Institute of Bioethics
The Johns Hopkins University ]

Within the Hinxton report, one has the text:

Statement of the Problem

Many research institutions, private entities, and individuals have obtained patents relevant to stem cell research and its application. These patents have been studied by individual groups of scholars. Some of the main conclusions from that body of scholarship are that (1) the public databases of patents are often difficult to search, and can be out of date, and incomplete; (2) despite generally similar legal criteria, the outcomes of patent examination in different patent jurisdictions are quite different; (3) IPR are copious and atomized into a profusion of patents with overlapping claims; and (4) no one is curating the global body of patent data. This has created a situation in which even a diligent stem cell researcher or entity that wishes to respect IPR will face considerable uncertainty and enormous costs if they try to survey the IPR landscape. Everyone suffers when there is no map for a new research area, and individual explorers are in no position to do the mapping and have no incentive to satisfy the needs of other stakeholders.

As to the United States, the statement --the public databases of patents are often difficult to search, and can be out of date, and incomplete -- is completely false.
The publicly available USPTO database on issued patents and published patent applications is easy to search, not out of date and not incomplete (except perhaps as to pre-1975 issued patents, not a concern for this discussion). Beyond the USPTO database, one has the LEXIS database on patents, and various patent services on the internet. How could the Hinxton Group make such a misrepresentation?

The Hinxton report also wrote:

The IPR Resource would link all relevant facets of stem cell IPR and represent a searchable database of primary patent data, i.e., patents and patent applications (e.g., drawing on the newly online US Patent Application Information Retrieval system, private patent compiling services, etc.), and be linked tosecondary resources, such as related academic publications (via PubMed, and including both scientific manuscripts and those on stem cell IPR), cell line information, etc. [The Public-Sector Intellectual Property Resource for Agriculture (PIPRA) and the Database of Genotypes and Phenotypes (dbGaP) represent partial models for this.]

The "primary" patent data of the USPTO (on issued patents) became a publicly available database more than 10 years ago, over the opposition of then Clinton-appointed head of the USPTO. Published applications were later added to the database. The --Patent Application Information Retrieval -- system [public PAIR] came later. Contrary to the Hinxton report, it is not "newly online" and PAIR is not about "primary" patent data.

The Hinxton report discusses what would be called an enablement issue in patent law:

Funding bodies and journals should insist that sufficient information is provided on methods in (or associated with) a publication, to allow other researchers to evaluate and replicate published experiments. In the event that it is discovered post-publication that insufficient methodology accompanied a manuscript, there should be mechanisms to add this information in a way that it is linked to the paper, via a mechanism similar to corrigenda and errata, perhaps as Amendments.

Of intellectual property, the Hinxton report writes:

Copious IP, including patents, has accumulated. Collective action could be taken to reduce transaction costs and bureaucratic friction that can intrude on market mechanisms to advance stem cell R&D and its early clinical applications. The profusion of patents signals that individual research institutions are hedging their bets, seeking patent rights as a matter of course, in the unlikely event that one of these patents will result in a huge financial payoff, but thereby creating a culture of pervasive patent infringement married to a potential option for prosecuting selected infringement later. The result is a broad shadow of uncertainty about freedom to do research and pursue applications. Another result is likely to be under-investment in new firms, high barriers to entry for new innovators, and slower progress for the field than if individual research institutions were more constrained and targeted in their seeking of patent rights. No one can move ahead without fear of later encountering lawsuits by patent-owners, and yet many of the key patents are held by research institutions with public missions.

Maybe the folks at WARF would like to comment on this one. The text --creating a culture of pervasive patent infringement married to a potential option for prosecuting selected infringement later -- could have come from Mike Masnick at TechDirt.


The following is an observer at the Hinxton group:

Elona Baum, who served for the past two years as director of regulatory policy and strategy for Genentech, joined CIRM April 21 [2009] as General Counsel. The prior 10 years she served as associate general counsel for the biotech firm.

“As CIRM moves to phases of its programming that are more translational and as we seek stronger ties with industry, I am thrilled to have someone with Elona’s background and expertise join my senior staff,” said Alan Trounson, CIRM President. “Her knowledge base fits neatly with where CIRM is heading.”

Baum holds a JD from University of San Francisco School of Law and a BA in economics from UCLA. She completed an externship with the California Supreme Court and had seven years of law firm experience prior to joining Genetech.


Blogger Unknown said...

The Stanford article was prompted by the recent consensus statement issued by the Hinxton Group ( with recommendations to address the challenges raised by data/materials sharing and intellectual property in stem cell science. I think it's fair to say that the international stem cell patent landscape is uncertain - this is an area in which different regulators have responded in drastically different ways (that's not including variations in regulatory responses to the science itself, which adds another layer of challenges.) The group's report details a number of valid concerns about problems with current policies and offers a range of recommendations for next steps.

10:49 AM  

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