Stanford v Roche; Ownership rights in federally funded inventions

The case of Stanford v Roche is a patent dispute over universities’ ownership of federally funded inventions — see extract in the text box below.  Victoria Henson-Apollonio who sent over the link said: 

“This is the sort of thing that we do need to worry about…. And, the CG doesn’t even have anything like Bayh-Dole that could be used as a basis to argue against the transfer of ownership!”

She went on to refer to certain agreements within the CGIAR system that have primarily have confidentiality provisions as their legal basis.

“Centers need to know about this case and to understand the risk that they may be taking on, by entering into such agreements without proper review.”

Practical steps suggested were to:

“(1) Review of all employment contracts for Centers that are involved in CRPs, especially the lead Centers, (2) Require that no confidentiality agreements be signed by any “CRP”-staff, again –especially the lead Center’s staff, without review and (3) Put together a practice note on confidentiality agreements, “Rights, risks, and responsibilities” 

Supreme Court Agrees to Decide Whether Universities’ Ownership Rights in Federally Funded Inventions Can Be Terminated Unilaterally By Individual Inventors

“The proper interpretation of the Bayh-Dole Act is the central question at issue in Stanford v. Roche. In 2005, Stanford University sued Roche Molecular Systems for allegedly infringing Stanford’s patents relating to methods for evaluating the efficacy of anti-HIV therapies, which Stanford had developed using federal funds. Roche claimed that Stanford could not sue to enforce the patents because one of Stanford’s faculty inventors had signed, while using a Roche lab, a visitor confidentiality agreement that purported to grant ownership rights in any invention that might result from work at the lab, supposedly leaving Stanford without full title to the patents. Stanford responded that it fully owned the patents under the terms of the Bayh-Dole Act, since Stanford researchers conceived the invention in the course of research using federal funds, and the Act grants universities and other non-profits the right to assume ownership in federally funded research, subject to certain restrictions and obligations designed to protect the government’s interest. The district court agreed.

 

The U.S. Court of Appeals for the Federal Circuit held, however, that the visitor confidentiality agreement transferred the Stanford researcher’s interest in the invention to Roche. The Federal Circuit held that the Bayh-Dole Act did not prevent the faculty inventor from unilaterally assigning ownership rights to a third party and thereby defeating Stanford’s statutory right to take ownership.” (Emphasis added)

 

For more analysis on the Stanford v Roche case see:

“Supreme Court to hear Bayh-Dole Patent Ownership Dispute: Stanford v. Roche” 

“Supreme Court to Take Up Stanford v. Roche”

 

USPTO, prior art & IP protection for plants in the US; Day #4 of the NPI meeting

The NPI week continued with a visit to the USPTO.  The building in itself started the day on an impressive note, as did the security system! The USPTO offices were built in 2005 and include five (5) buildings named in honour of important actors of patent history. 

The learning experience started at the Global Intellectual Property Academy with a general overview of the USPTOs history and function. We learned numerous interesting facts on the American history in general and on the subject of patents, i.e. that intellectual property goes back to the American Constitution written by the founding fathers.

We then spent some time with Mary Hale, supervisor in the electronic information centre, who took us through the prior art search systems. This presentation triggered many questions on the issue of the USPTO employees’ access to information and databases. Suggestions were then made by the participants concerning national databases that should be incorporated in the internet tools available to employees. It was obvious that it was crucial to them to avoid having the information on national resources overlooked in the research of prior art.

After lunch Anne Marie Grünberg, Supervisory Patent Examiner, presented “IP protection for plants in the US.” She took us through the three (3) types of protection available in the United Sates for plants: 1) the Plant Patent; 2) the Plant Variety Protection, and; 3) the Utility Patent. She then explained how and why these different protections are used. Anne Marie’s presentation and dynamism also sparked many questions from the NPI group. Questions were centered on the details of; whether it is common to apply for both a patent and PVP? (answer: in her experience, it was more common to apply for a plant utility patent and PVP) what does PVP offer that a utility patent does not? (answer: there are different advantages to these protections, for example, the scope of a utility patent can be broader, while it is less expensive in the long run to have PVP).  There was also discussion around the limitations to all these modes of protection, i.e. the farmers’ and breeders ‘exemption which does not exist under the Patent Act, while it is important in the PVPA. Personally, I was surprised to discover that research exemptions are absent from the US Patent Act, which makes the patent scope even larger in the United States. 

post written by Gabrielle Gagne, National Partner, Canada

Just to add, Hanumanth Rao had the opportunity to raise with the USPTO about the work that ICRISAT & CAS-IP have been working on with the EPO to have CGIAR materials included in their prior art searches.  See the information on the following link for more details of this: http://www.cas-ip.org/projects/cgiar-centre-publications-as-prior-art.  Minna Moezie, the Attorney-Advisor who led the day’s proceedings invited Hanumanth to contact her directly so they can consider the possibilities. — Kay Chapman

 

Plumpy’nut legal battle and the idea of “global responsibility licencing”

A very interesting article on the BBC website last month describes a legal battle over a “hunger wonder product”. “Legal fight over Plumpy’nut, the hunger wonder-product”

The product is “Plumpy’nut” (more details on the Wikipedia page) and there are lots of emotive issues!

1)Children are starving, 2)There is a product that helps reduce illness and death from malnutrition, 3)This product is protected by a patent held by a private company based in France; Nutriset[i]. 4) Nutriset now face a lawsuit  because the “patents on its therapeutic food formulas are overly broad, prohibiting other groups from producing similar food intended for malnourished people”[ii]

As I said, lots of emotive issues…

An allbusiness.com link reported that Doctors without Borders released an open letter:

“…scolding Nutriset for hindering efforts by other groups to distribute products similar to its formulas.  “There needs to be more than one [worldwide] supplier to ensure a secure supply chain,” wrote Dr. Tido von Schoen-Angerer in a November 2009 letter. “The intellectual property pertaining to nutritional products of a humanitarian nature must therefore be handled differently from that pertaining to commercial products.”

And therein lies the argument that underpins this, and many other similar stories.  IP relating to a product with a humanitarian nature should somehow be “handled differently”.  The BBC article highlighted a quote from Stephane Doyon of Medecins Sans Frontieres:

“in a domain as sensitive as humanitarian aid [patents] need to be handled with extreme flexibility”.

But how? Are we looking at a failing in the current system, an error, or a change in expectations of what a patent should do?  Arguably, without IP protection many innovations would fail to materialise.  One argument brought forward in the article was that IP protected by Nutriset[iii] can be used for development purposes. The Nutriset’s communications manager was quoted as saying

“If the US companies were able to beat the patent, the global volume of RUTFs would of course go up. But it would also mean the end for our local partners in Africa, who wouldn’t be able to compete. That is not what we want.”

How can we ensure these ends are protected too?

There is one group that has a suggestion, and they are working towards realising the idea!  View this short clip for more details.  An inspiring presentation given at Davos 2010 for “Global Responsibility Licencing“.

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[i] Click here for the patent information and here for information about Nurtiset.  [ii] See also “Fullbright goes pro bono in IP case over food for the hungry” for information about the case.  They have apparently been issuing cease-and-desist letters to competitors.  [iii] Nutriset position themselves as a “company 100% dedicated to humanitarian programs nutrition” for information purposes note they are a private enterprise

EPO action on Green Patents

Guat Hong Teh sent me this link to an article in Nature http://www.nature.com/news/2010/100505/full/465021a.html describing an EPO initiative to make clean energy patents easily accessible in a central database:

The EPO trawled through 60 million patent documents and re-classified clean-energy patents according to 160 technical categories, such as carbon capture and solar photovoltaics. This should make it much easier to find patent information. The database launches in June through esp@cenet (http://www.espacenet.com), a gateway to European patent databases. Last year, the EPO received 1,259 renewable-energy patent applications, up 27% from 2008, and the new database will be updated daily to include the growing number of energy patents filed at patent offices worldwide (see ‘Going green‘).

This is a real groundbreaker and is part of a trend that includes a fast-track program for green energy patent applications in both the USA and the UK.

A reminder that CAS, particularly through working with ICRISAT, has been instrumental in ensuring that literature relating to CG innovations is included in EPO’s non-patent literature database. Victoria Henson-Apollonio observes that:

This ensures that patent examiners are more fully informed about prior art and helps make sure that patents don’t cover what is already known and has been put forward by others; and this results in better quality patents.

Back to green patents: check out the Global Innovations Commons.

As part of their public service program, financial and IP innovator M•CAM has assembled an impressive database of public domain IP – mostly expired patents –  in categories such as agriculture, soil erosion and solar energy.  This information is freely available, but…

…here’s the catch. We’re sharing this under a license. The license is really simple. If you use this information, you must share what you’re doing with everyone else. If you improve upon it, you must share your improvements with everyone else. And finally, if you use any of this information, you must reference the “Global Innovation Commons.” That’s it. When you take the next step, turn the possibilities into realities.

Post written by Peter Bloch, consultant to CAS-IP

“IP Litigation in Africa”

“IP Litigation in Africa” was an item in the WIPO magazine from February this year.  It includes highlights from IP disputes that have recently taken place Africa.  In the introduction Darren Olivier (co-founder of Afro-IP blog) says:

“IP dispute resolution is alive and well in most economically vibrant economies on the continent”

Examples are from Ethiopia, South Africa, Namibia, Kenya, Uganda and Nigeria and deal with patent, trademark and copyright cases.  We often read about lack of enforcement in the region, so it’s very welcome to see an article of this kind!

Bilski v. Doll

http://www.patentlyo.com/patent/2009/06/bilski.html

Victoria Henson-Apollonio recently sent me the above link saying: “this is a big deal, a very big deal….” In fact, another indicator of it’s importance is the existence of its own dedicated Wikipedia page. 

The story dates back to 1997 and an original patent application including business method claims.  It has progressed to the situation reported on PatentlyO this month whereby:

“the Supreme Court has granted certiorari in …[this] important case challenging the scope of patentable subject matter.”

The Patently O blog has been updating coverage on this case since February 2008 so visit the lead link for the list of their previous posts on this matter.

Also, in their usual no-nonsense style, the IP Kat posted an update on the situation.  IPKat said:

“Whether this will sort out the mess that the USPTO is currently in about the boundaries of patentability is anyone’s guess.”

Clearly a case to be watching!

Pirates in the European Parliament!

http://news.bbc.co.uk/2/hi/technology/8089102.stm
The recent European elections saw a Swedish group called the “Pirate Party” win a seat in the European Parliament.  According to the BBC article:

“the group – which campaigned on reformation of copyright and patent law – secured 7.1% of the Swedish vote”

These issues have been attracting international attention and comment during the “Pirate Bay” case that was held in Sweden.  See earlier CAS-IP blog posts:

https://casipblog.wordpress.com/2009/06/01/the-pirate-bay-case-again/
https://casipblog.wordpress.com/2009/05/20/the-pirate-bay-plot-thickens/
https://casipblog.wordpress.com/2009/04/30/the-pirate-bay-decision/

The BBC article included the following quote from Rory Cellan-Jones, the BBC technology correspondent:

“Many people just don’t see illegal file-sharing as a crime, however hard the media industries try to persuade the public that it’s just as bad as shoplifting”

This gives food for thought over the attitudes of the public regarding these issues!

Patent Law. Ariad v. Eli Lilly

http://www.patentlyo.com/patent/2009/04/written-description-pioneering-clams-require-broader-written-description.html
Ariad v. Eli Lilly, this case even has its own wiki page!!! http://en.wikipedia.org/wiki/Ariad_v._Lilly

Relevance for agricultural development?  This was a patent that was definitely a pioneering effort in the field of small molecule effects on cellular function. The courts have ruled that the claims overreached what the inventors had, in-hand, when the patent application was filed. A common (often valid) concern is that when ‘break through’ innovations are the subject matter of a patent application, the patent office examiners are not really prepared to deal with the new subject matter in a way that is as thorough as examineations of applications filed when a technology becomes ‘mature’. This ruling should give some comfort to those that feel that early patent rights on any new technology are so broad, as to prevent any utilization of the innovation in the future.

The original patent was filed by three BIG powerhouses of innovation in the U.S., M.I.T., Harvard and the Whitehead Institute. Two of the inventors are Nobel Laureates!

Post written by Victoria Henson-Apollonio

Microsoft patent case against TomTom

Link 1 ZDNET

Link 2 ZDNET

Link 3  The Register

This is a hot intellectual property story doing the rounds at the moment.  It has certainly created a lot of attention (and anger!) which is apparent in the hundreds of comments left on the above linked news sites.  In short a patent infringement case has been filed by Microsoft against TomTom (the makers of in-car sat nav systems).  However, the real “story” seems to be a larger issue being described as “the first shot fired by Microsoft vs. Free Software” (see full blog posting).  This in turn is making some nervous that Linux might be next in the firing line (see item here) It’s going to be one to watch for those involved in open source-projects.

Pity the lawyers?? Crop scientists say biotechnology seed companies are thwarting research

http://www.nytimes.com/2009/02/20/business/20crop.html?em

This article published last week by the New York Times (see lead link) and reprinted in the International Herald Tribune  describes the frustration of a group of entomologists doing research at land grant universities in the U.S. regarding the contract conditions attached to the use of materials obtained from several major seed companies.  These scientists have sent a letter the U.S. Environmental Protection Agency (EPA) indicating that the have had difficulty in running the experiments needed to test hypotheses, regarding the optimal size(s) of refugia, because of the conditions proscribed by the owners of the materials when they were passed to the scientists for research studies.  Everyone agrees that this research needs to be done.  The scientists wonder, how this can be accomplished –given the contract language.  Now, how will the EPA be able to ask whether their current regulations are sensible?

What does this have to do with intellectual property?  Rights are awarded to patent holders; these rights can then be licensed to others.  Owners of intellectual property rights have great liberty in the conditions associated with licensing the use of materials under patent protection.  In corporations, the text of these licenses is usually under the control of legal departments.  This can bring problems when lawyers see their job as one of reducing risk to as close to zero as possible.  The situation described in this article perhaps provides an example of the difficulty lawyers have when trying to draft an agreement that provides sufficient room for a licensee to use the material in a productive way and yet also provides sufficient risk management for the licensor. 

Here is a very interesting discussion by a patent attorney regarding this situation: http://www.patentdocs.org/2009/02/new-york-times-gets-one-right.html

Additional comments regarding U.S. regulatory agencies involved in approvals of GMOs from:
http://patentbaristas.com/archives/2009/02/20/scientists-say-seed-technology-agreements-stop-research/

The above blog post was written by Victoria Henson-Apollonio

A draft of this post was circulated internally last week and Guat Hong Teh, a lawyer on the CAS-IP team had the following comment to make.

“In my view, putting the right language into licences that would enable both the licensor and licensee to achieve their goals (common or not) is a joint effort. Whilst it is reasonable to have some standardisation of legal language in these documents, both lawyer and scientist need to understand that a case-by-case approach is necessary when new situations emerge. A good piece of legal document requires extensive communication between all parties involved. However, there is sometimes a communication breakdown between the scientist and the lawyer because of the seemingly different roles they play or the goals they would like to see achieved. Although the duty of the lawyer is to ensure that his/her client is afforded the widest protection allowed under the law, this has to take into consideration other needs of the client. I see this to be an increasing challenge for what we do because of the rise in collaborative research, especially public-private partnerships.”