Blogging Biodiversity

Blogging Biodiversity

International negotiations from a personal perspective

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Does the USPTO get the last laugh?

It’s always nice to have chance to go back and update things you were looking at a few months, or in this case, more than a year ago. In February 2007, I blogged about Tim Roberts’ application for patenting jokes. This prompted much discussion in the comments between him and I as well as a further post on my part. I thought it would be nice to take a look to see where the patent application stands now.

It turns out that on June 3rd of this year, the USPTO sent Mr. Roberts a ‘non-final rejection’. Unfortunately, the language of the rejection is much less entertaining than the language of the original application.

In paragraph 6, the patent examiner rejects all the claims in the patent application “because the claimed invention is not supported by a credible asserted utility.” The patent examiner also stated that the claimed invention does not fall within one of the four statutory classes of invention under US patent law, i.e. it is not a process, machine, manufacture or composition of matter. I liked the dryness of the next bit:

In particular, it is unclear as to what statutory class of invention a “joke” falls under. Additionally, it is unclear as to what statutory class of invention a “patent application” and “application” falls under.

The claims were also rejected on the grounds that they did not distinctly claim the subject matter that the applicant considers to be the invention. Paragraph 14(a) of the reasons states that:

Claim 1 recites “protecting a novel joke”. A person of ordinary skill in the art is unable to determine the metes and the bounds of the Applicant’s invention because the word “novel” is subjective.

I love how, with no apparent irony, the patent examiner can refer, on the one hand, to the standard of ‘a person of ordinary skill in the art’ as though it is somehow plain and obvious who this metaphoric person is and what the ordinary skills are that he or she possesses, and then proceed to state that the claim is rejected because the word ‘novel’ is subjective!

I must confess that I haven’t checked on the status of the application in the other countries where it was filed but if the US isn’t broadening its scope of patentability to accommodate your claims, I would say that things aren’t looking too good for you.

I am glad, then, that I did not take up Mr. Roberts on his offer of ‘very reasonable terms’ for a license for the subject matter claimed by his patent application. According to the cover pages that accompany the ‘action’ from the USPTO, though, Mr. Roberts has three months to reply to the non-final rejection from the date of its mailing. All is not necessarily over then and I believe three months brings us to September 3rd, just over a week away. So I turn the floor over to Mr. Roberts and invite him to give Blogging Biodiversity a sneak peak at what his next actions might be.

Publications news

I am currently holding in my hot little hands my very own copy of Patenting Lives: Life Patents, Culture and Development. The book is edited by Johanna Gibson and published by Ashgate. I authored chapter 2 - ‘Life as Chemistry or Life as Biology? An Ethic of Patents on Genetically Modified Organisms’. Thanks to my lovely husband for the illustrations in the chapter. You can see the full cite for the chapter on my publications page.

The book is the product of the Patenting Lives conference, which I attended way back in December 2005 (see here and here). I see also that fellow contributor, Luigi Palombi, has been in the news lately in Australia where the company Genetic Technologies has announced it will enforce its patent rights over the BRCA1 and BRCA2 genes, see stories here and here. I’ve written on the BRCA gene patents in the past, particularly in the piece on ‘Health Care and Access to Patented Technologies’ (sorry, the link from my publications page is broken. I will work on fixing it as part of the housekeeping.) It’s interesting to see debates on the gene patents taking place in other countries as well as concerns being expressed about the effects of these patents on the price of health care .

I also see where the occasional paper on the relationship between the CBD and the ITPGRFA co-authored by myself and Christine Frison has been cited in a recently published article in the Journal of World Intellectual Property. The article by Claudio Chiarolla looks at ‘Plant Patenting, Benefit Sharing and the Law Applicable to the Food and Agriculture Organisation Standard Material Transfer Agreement’. You can find the article for free in both html and pdf format here. I’m hoping that the occasional paper might be available in a couple of other languages in the not too distant future as well.

Finally, I still have some publications in the pipeline so there will be more news on this front down the road.

Still ticking

It has been a while since I posted anything and there are some things that I’ve been wanting to post about. I was off at MOP-4 to the Biosafety Protocol in May when the blog was attacked by spammers. I upgraded to a new version of WordPress, hence the current more spartan look to the blog. I am currently on holiday from my regular job and so will try to do a few updates over the next few days.

At the very least, I’ve managed to go through the backlog of comments and approve the valid ones and delete the spam. Thanks to all who’ve commented, I’ll endeavour to reply as I do some housekeeping.

I haven’t been checking the stats for hits to the blog lately so I don’t know if I still have any faithful who are looking in periodically for anything new. If there are, thank you and I promise some new material over the coming days and hopefully, I’ll fix up the new look of the blog also.

Beans, beans, the litigious fruit…

Nearly a year ago, I wrote a post declaring that the US Board of Patent Appeals and Interferences (BPAI) had rejected Larry Proctor’s patent claims to the Enola bean. Well it turned out I was ahead of things and the BPAI hadn’t even heard the case.

I’m currently updating the presentation for which I was doing the initial research on the enola patent in preparation for speaking at the Faculty of Law of the University of Ottawa on February 20th and I have developments, this time accurate (I think), on the enola case.

First of all, the BPAI has now heard the case - on January 16th of this year as it turns out. The hearing included a rather interesting exchange between Proctor’s lawyer (Mr. Lee) and the judge. As I understand it, the claims in Proctor’s patent largely rest on the enola bean being a unique colour of yellow. As part of the re-examination of the patent, Proctor supplied samples of ‘prior art’ to the patent examiner. This prior art consists of other types of beans of a similar shade of yellow but not the same shade. Proctor (or his legal team) couldn’t, though, get access to all the prior art they had cited and the patent examiner asserted (or so says Mr. Lee) that it was up to Proctor to supply all the prior art as he has better access and facilities for this than she does:

MR. LEE: … I think her position is that she has looked at it, and yes, it is true what she has seen based on the Munsell [Book of Colour] testing we did that the prior art she has isn’t right on. It nonetheless falls upon us to find it because she doesn’t have the facilities to do it.

JUDGE GRON: But then she makes a back statement and says, But how can I really tell? Because I can’t understand what the scope of your claim is.

And then you go back and say it is what is deposited. But as we said earlier, if you get something from the deposit, it may or may not fall within the scope of your claims. Wow.

The last part of the exchange refers to an earlier discussion between Mr. Lee and the judge about how the distribution of a particular phenotypic characteristic in a given sample of seeds/plants of a particular variety will be distributed along a bell curve. The result is that any one seed in the sample of enola beans deposited with the ATCC (American Type Culture Collection) may not, when grown out, display the phenotypic characteristics that are claimed in Proctor’s patent.

The exchange brings to mind an argument I’ve made in a forthcoming publication about how patent law has attempted to assert control over living organisms even while these are still autonomous. The fact that any one seed of the patented enola bean may not actually fall within the fences erected by the patent claims - the fences that are supposed to contain the bean - seems to illustrate the point quite effectively.

The exchange also points to how the specification requirements of patent law - and the allowances for depositories that are supposed to circumvent the impossibility of fully describing living organisms - are not well-suited to the uniqueness of living organisms.

Does anyone out there know approximately how quickly the BPAI issues its decisions after a hearing has taken place? I’m guessing about 6 months. We’ll have to keep watching to see how this is decided. Even if Proctor’s claims are denied, he can still appeal further.

The other update concerns further resources related to this case. My initial post pointed to the Patent Application Information Retrieval system. This is still true, head there and search for application number 90/005,892. Then click on the tab called ‘Image File Wrapper’ and this should give you access to pdfs of the US Patent and Trademark Office’s documentation on the case. The file with the record of the BPAI’s oral hearing of the enola case from which I drew is the above quote is called ‘Miscellaneous Action with SSP’ and is dated 02-06-2008.

I’m not sure if the instructions from my March 2007 post were wrong - like some of the rest of it! - or if things have just been moved around since then.

And of course, I stand to be corrected by other experts out there if I’ve got facts related to enola patent wrong again.

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The Future Control of Food

A new book, ‘The Future Control of Food: A Guide to International Negotiations and Rules on Intellectual Property, Biodiversity and Food Security’ is set to be launched and published over the next couple of weeks. The book was co-edited by Geoff Tansey and Tasmin Rajotte and is available from Earthscan and the International Development Research Centre.

I’m very proud to say that I contributed to the chapter on the Convention on Biological Diversity.

The Quaker International Affairs Programme (QIAP) is organizing a side event this Monday (January 21st) at the 6th meeting of the CBD’s ABS Working Group. The description of the side event states the rationale behind the book:

The decision to produce this book was a response to concerns negotiators in various multilateral negotiations raised about the need for such a guide as well as an observation that negotiators or groups working in one area were often unaware, and sometime undermining, what was happening elsewhere.

Bravo to QIAP for all the work in putting the book together and happy reading to everyone!

Arrivederci, blogosphere

So I was all set to celebrate my second anniversary of Blogging Biodiversity and to bring you wall-to-wall coverage of the fifth meeting of the CBD’s ABS Working Group when I got a new job!

I am now the Legal Officer for the Biosafety Unit of the CBD Secretariat.

Needless to say, this changed things quite a bit. I didn’t attend very much of ABS WG-5 and, as a member of a United Nations secretariat, I am now more limited in what I can say. Certainly, I won’t be blogging meetings in my new position and publishing on the internet my opinions on CBD negotiations is probably not such a good idea.

I may still post the occasional news story that’s just too good to pass up but don’t expect much commentary. In that vein, I note that the farmers in Hoffman v. Monsanto have had their request for leave to appeal to the Supreme Court of Canada denied. As usual, no reasons for denying the request were given by the Court. You can read thoughts by Jeremy deBeer here. There’s also been a couple of interesting ‘ABS in Canada’-related posts on the blog of McGill’s Centre for Intellectual Property Policy, see here and here.

I am also anticipating that a couple of publications I had in the pipeline prior to the new job will make it to print. I will be sure to announce those as well and post links and citations as appropriate.

Arrivederci for now. Please come say ‘hi’ if we both happen to be at the same meeting.

Shall we “saucissoner” ABS?

I see where Bioversity International has a video podcast of Michael Halewood (head of policy at Bioversity International) offering his thoughts on the outcomes of the 11th session of FAO’s Commission on Genetic Resources for Food and Agriculture, held in June of this year.

Michael comments on the Commission’s decisions to consider all aspects of genetic resources for food and agriculture (e.g., aquatic, forest, microbial genetic resources, etc.) and not just to stick with plant genetic resources for food and agriculture (PGRFA) that has largely been it’s focus to date. In the past, while the Commission was focusing on PGRFA, most other types of genetic resources were left to the CBD. The Commission also gave itself the mandate to look at access and benefit-sharing in relation to all these different types of genetic resources.

In a Bioversity press release, Michael also comments on the necessity of a cross-sectoral approach to ABS and these different categories of genetic resources.

I have no argument with the fact that the use of genetic resources for food and agricultural purposes is special. Food is a basic human necessity, everyone must eat and many people rely on agriculture for their economic well-being. We are seriously jeopardising our future security if we lose agricultural biodiversity.

Easy access to genetic resources is helpful in order to allow the research and development necessary to develop new crop varieties and prevent things like wheat rust from wiping out harvests.

What I am concerned about, though, is where some of this focus on the particular nature or uses of genetic resources for food and agriculture might be heading. Friend and colleague Christine Frison had a great French term for it - ’saucissonner’ - are we going to try to divide genetic resources into small discrete - but connected - packages like sausage links?

I am not convinced that this is feasible or advisable.

 sausage links
ABS as sausage links? Not sure this is a good idea

My concern is that the international community is going to start to develop rules for different types of genetic resources ‘for food and agriculture’ and also potentially for different types of genetic resources for other sorts of uses as well.

Don’t get me wrong, I think the International Treaty is great. It’s innovative international law and could make important contributions to the conservation and sustainable use of plant genetic resources.

I’m just not sure that it’s a model that should be repeated for all different types of genetic resources and different uses of said resources. The international community could create rules on:
- plant genetic resources for pharmaceuticals or
- aquatic genetic resources for pharmaceuticals or
- plant genetic resources for cosmetics or
- micro-organisms for industrial enzymes or
- micro-organisms for pharmaceuticals.

Starting to see the problem?

I feel that this could result in a mess of rules that actually makes the whole situation much more complicated rather than facilitating access to different types of genetic resources.

My concern is based in part on sentiments I came across during some other research where people felt that agriculture is very different from pharmaceuticals which are very different from industrial enzymes, etc. The view was that it was impossible to design rules that would cover all fields and that it was inappropriate to try. Rules should be based on the specifics of the industry concerned.

For starters, it is not always clear when a genetic resource is accessed what sorts of uses it might have. Much science is based on serendipity. How will anyone know which rules to follow if determining the applicable set of rules rests on the use to which the genetic resource will be put and this isn’t clear?

Furthermore, there isn’t necessarily a clear-cut distinction between different types of uses. One of the challenges countries will face in coordinating their implementation of the rules on access under the International Treaty and rules on access under the CBD is determining what is meant by ‘for food and agriculture’. The International Treaty’s Multilateral System of Access and Benefit-Sharing only applies to the list of crops and forages in Annex I to the Treaty when these are accessed for the purpose of food and/or agriculture. The rules of the Multilateral System do not apply when these crops and forages are accessed for other purposes. But what makes a purpose ‘for food and agriculture’?

As I’ve written elsewhere, an illustrative example would be Golden Rice. Golden Rice is rice that has been genetically engineered to produce extra vitamin A in order combat vitamin A deficiencies in children – deficiencies which can lead to blindness. Golden Rice was obviously intended to be grown and eaten so it can be considered as the use of plant genetic resources for food and agriculture. It was also intended, however, to combat a health problem which would not be the use of a plant genetic resource for food and agriculture. So which rules apply? Those for plant genetic resources for food and agriculture or those for plant genetic resources that are not for food and agriculture?

Creating rules that apply to specific sets of genetic resources or specific uses of genetic resources could just exacerbate this issue rather than adding clarity and making ABS rules easier to apply and follow.

A realpolitik perspective on the sector-by-sector approach is that it can also be used to break down negotiators from developing countries who won’t have the financial or human resources capacity to follow all the different little parts or negotiations taking place in different fora.

Debate on the sector-by-sector approach is not mere idle speculation. For the upcoming fifth meeting of the CBD’s ABS Working Group, the European Union is proposing consideration of ’sectoral work on standardising Material Transfer Agreements’ (see p. 47-52 of document UNEP/CBD/WG-ABS/5/INF/1.) This appears to be a proposal for a limited application of the sector-by-sector approach.

I’m ready to be convinced that I’m wrong and that a sector-by-sector approach to genetic resources is, in fact, the way to go. But count me among the skeptics for the time being. Genetic resources as sausage links? Not to my mind.

Further thought on request for applications for ICBGs

Is it just me, or is it somewhat ironic that institutions of the U.S. government are promoting ‘rigorous observance’ of the CBD when the U.S. isn’t a Party to the Convention?

Just asking.

Basic vs. commercial research

I see courtesy of the good folks at the Agricultural Biodiversity blog that there’s a new request for applications for International Cooperative Biodiversity Groups (ICBGs - I blogged about one of the previous ICBGs in my series of ‘Gorilla medicine’ posts starting here.)

The details of the requirements are available on the website of the U.S. National Institutes of Health (NIH). I was trying to find when the decisions on who would be awarded the grants might be made and stumbled across a section in part VI on ‘principles for accessing genetic resources, the treatment of intellectual property and the sharing of benefits associated with ICBG-sponsored research’.

Apart from requiring compliance with national and international law (including the CBD), the section includes an interesting distinction between basic and commercial research. In discussing ‘disclosure to and informed consent of host country stakeholders’, the request for applications states:

Where national governments do not have clear regulations to guide informed consent procedures, activities should follow a two phase approach to distinguish basic and commercial research. Basic research intended primarily for publication, including collecting and analyzing biodiversity, including bioassay and chemistry work, may be considered “basic” research for the purposes of this program. If, at any time, researchers intend to file a patent application based on this work or to send a sample for testing to an industrial partner, the research immediately enters the commercial realm for the purposes of this program and must follow all the requisite permit and contract standards of the host country.

There’s a lot of discussion in ABS circles about distinguishing between basic and commercial research in order to apply to different rules to each. The prior informed consent process for commercial research is often more involved as are negotiations for the sharing of benefits. There’s general agreement that basic research should not be stifled by being subject to the same requirements.

The problem, though, is how to distinguish between basic and commercial research. It looks to me like the NIH has a good approach to making this distinction - as soon as researchers intend to file a patent or send something for testing to an industrial partner it becomes commercial research. This may mean you have to go back to the country and negotiate new terms.

My only quibble is whether the distinction should be limited to the filing of patents or should also include plant breeders’ rights. This can quickly start making things very blurry again, though, as why not also include copyright or trademark protection as the threshold for entering commercial research? But does publishing a journal article and the accompanying copyright constitute commercial research? Some have already suggested that it’s biopiracy so the argument is not necessarily far-fetched.

It doesn’t help make the distinction between basic and commercial research any more clear-cut, though.

US moving to UNCLOS ratification?

Following on from my post about marine genetic resources from a couple of months ago and the subsequent discussions in the comments about countries that are and are not Party to UNCLOS (the United Nations Convention on the Law of the Sea), I see that the August 9th edition of Nature has a piece entitled “Strife on the Seven Seas” (unfortunately, behind a pay wall.)

The sub-title of the article is “The sight of nations jockeying for position on the high seas is becoming more common. An international treaty exists to deal with such disputes and it is time for the US Senate to ratify it.” So Nature is urging the US to ratify UNCLOS.

The article seems to be largely prompted by Russia’s recent planting of its flag on the bottom of the Arctic Ocean. Nature discusses how there is increasing competition for the ocean’s resources and the need for law to govern how these resources are divided up and the environment protected:

When humans were less able to harm the sea — skating on its surface in wooden boats and taking resources in relatively small quantities — it could be a lawless common. But now our society must manage the sea very carefully, lest the waters become a lifeless waste.

The article also mentions the discussion on marine genetic resources at UNICPOLOS: “The treaty’s scope can expand as fresh issues arise: at the convention’s most recent meeting, in May in New York, a framework for dealing with marine genetic resources was discussed.”

The article also supports the point I made in the comments following the June 20th post that, while the US isn’t formally a party to the treaty, it does abide by many of its rules and obligations:

In practice, the United States already abides by nearly all of these provisions. So why has the treaty languished there since 1994 without its ratification even being considered on the Senate floor? At one point, opposition focused on a section on seabed mining that representatives of some nations considered too
restrictive. But since that was rewritten, also in 1994, opposition has been confined primarily to a dozen or so conservative senators who are philosophically opposed to the encroachment of UN rules on what they regard as the United States’ rights as a sovereign nation.

Perhaps most important, though, are the repeated urgings for US ratification of UNCLOS.

the US Senate has yet to ratify the country’s membership of the convention. It should do so immediately, so that the United States can play a grown-up role in the development of the framework established by the treaty.

The piece ends with a listing of the different factions in the US that now support ratification including the environmental lobby, the oil industry, the US State Department and even the Bush administration. It is hard to imagine this administration supporting the US joining any United Nations-based multilateral initiative but I’ve heard similar rumblings about the US possibly ratifying the FAO IT because they can’t afford to be left out. We’ll see.

Anyway, US ratification of UNCLOS isn’t entirely in the administration’s hands, requiring instead Senator Joseph Biden, Chair of the Senate Foreign Relations Committee, to bring a resolution of ratification through the Committee to the Senate floor. According to Buxbaum, the administration is campaigning for ratification and Senator Biden is considering a hearing of the matter by the Committee in September. But ratification requires a majority two-thirds vote in favour in the Senate, definitely not a given.

For lots of links and discussion of US ratification of UNCLOS, see Anthony Clark Arend’s Exploring International Law blog at Georgetown University.