To follow by Email (RSS Feed)

Saturday, March 9, 2013

A Defense of Plant and Crop Related Patents


Patents involving plants are often portrayed as a seriously negative phenomenon.  In fact, they play an important and beneficial role in the development of better and more productive crops.  As I have watched the controversy around the role of patents, particularly as related to biotech crops, it seems that critics have little understanding of why the patent system was created in the first place, how the patent system actually works, and what patents do and don't mean in the commercial realm.

I would like to explain why, rather than being some sort of sinister tool of conspiratorial control, patents on plant varieties and on biotechnology innovations are key drivers of the investment and creativity that we will need if we are to meet the food supply and environmental challenges that lie before us over the next few decades.

The Grand Patent Bargain

Patent systems were set up to provide creative people with the incentive to invest their time, money and talent in the development of inventions that could benefit society.  To do that, the following bargain was struck:  the inventor gets a specifically limited period with the exclusive right to derive economic returns from the sales/use of the invention only if they meet two standards.  First, they must make a sufficiently strong case that their invention demonstrates "novelty," and second, they must fulfill "the obligation to teach."  I'll unpack that below.

Proving Novelty

To receive a patent, an invention has to "exhibit novelty" meaning that it is different from similar inventions ("in the prior art"), and that novelty has to be something that is "non-obvious to one skilled in the art."  Anyone who has ever pursued a patent knows, it is quite hard to meet that standards.  Even after a patent is awarded, the novelty question can - and frequently is - disputed in court if the patent turns out to have any significant economic ramifications.  As I heard in my first company-sponsored training on the subject, "a patent is only a license to be sued."  The effort and originality involved in patenting of plant lines and of genes is often spoken of as if it is some trivial, and thus undeserving activity.  That is only believable if you've never engaged in the process.

The Obligation to Teach


When someone develops something new and hopes to profit from having done so, the main alternative to patents is what is called a "trade secret." If you pursue a trade secret strategy, you hope that the details of your product or process are sufficiently obscure that others can't imitate it.   To get the more certain period of exclusivity offered by a patent comes with a requirement that you explain your invention in detail sufficient to allow any qualified reader the ability to understand exactly what it is and how it works.  This "teaching requirement" is actually the genius of the patent system. To get temporary exclusivity, you have to reveal information that will very often give competitors ideas about how to do something even better or otherwise "work around" your patent.  Also, often years before a patent can get through the process to be awarded, it is"published" so that what you teach is available to everyone else sooner than you get the patent or even if you never get it. The system forces a level of idea-sharing that would never have happened without it.

In my paying job as a technology consultant (as opposed to time I spend blogging), I frequently help companies monitor what their competitors and the academic community are doing in a specific area of science.  I find that recently published patents are an extremely useful window on such a question (try this yourself on the search page for the patent office.  type something like ttl/rose to see how many patent applications have been filed just for roses).  Mind you this is not a collegial exchange of information.  Between the dull, precise nature of scientific language and the obtuse nature of lawyer-speak, patent applications must be in competition for the most tedious form of writing (I know because I have to read these).  Still, it is a form of real idea exchange that is forced by the patent system.  The grand bargain works for the benefit of society.

Who Patents Plants and Plant-related Technologies?


The modern anti-biotechnology narrative would have you believe that certain companies (Monsanto usually being portrayed as the ultimate demon) are using patents in some new paradigm to "control the food supply." This view ignores the fact that plant variety patents have been a common feature of crop genetics since 1970 and that a great many of those patents are held by universities, by the USDA, and by similar international agencies (Patents for vegetatively propagated plants have been an option since 1930).  Actually, the most foundational tools of biotechnology for plant, pharmaceutical or industrial use were patented by scientists at Stanford University.  For a time, any group that did genetic engineering needed a license to the Stanford-held, Cohen-Boyer patents that are now considered a "gold standard" for university licensing.

When, in the 1990s, commercial biotechnology entered the agricultural seed market space, the fact that such products were patented was nothing new.  For decades, commercial, academic and government researchers have typically patented their inventions.  None of this is sinister.  If someone develops a crop variety that has real economic value to farmers, it does not matter whether the innovation originated in the public or private sphere, it may well be patented.  For any entity to take the following steps to commercialize that trait, the temporary exclusivity afforded by a patent makes it worth their effort and investment to do so.

How Much "Control" Does A Patent Provide?


A patent on something like a gene for potential use in a biotech crop means very little by itself.  There are typically many patents covering parts of or steps in the process of bringing that trait gene to the market - often patents controlled by different entities.  For instance, as soon as genetic engineering became a possibility in the 1970s, many groups were interested in finding a way to make plants resistant to the very broad spectrum, low toxicity herbicide - glyphosate.  It turned out to be difficult to get a form of the effected enzyme, EPSPS that would not be inhibited by glyphosate but which would still serve its normal function for the plant.  It ended up requiring two distinct changes at different positions in the enzyme.  The group that finally generated a modified gene that did the trick (designated as "CP4") worked for a small start-up biotech company in Davis, California called Calgene.  The investors and scientists there were rewarded for that breakthrough when Monsanto commercialized the trait.  Still, that was only the beginning.  For this enzyme to function properly it has to move into the chloroplasts in the cell.  That means it has to be linked to a Chloroplast Transit Peptide and the patent for that was awarded to a European biotech company (there were several major European players in the early days of this science).  Monsanto had to pay a royalty to that company for rights to use the patented sequence.

There are patents covering the steps required to actually get a new gene into a plant.  For some time, the preferred method of doing that has been with the help of an organism called Agrobacterium.  For many years, any company that wanted to use a special strain of that bacterium which would do that job with monocot crops (e.g. corn, wheat, rice...) needed to pay for rights to use a strain that was discovered by scientists at a Japanese company called JTI.

Once a gene is successfully inserted in a particular specimen of a crop in such a way that it is expressed functionally and does not cause any other problems, such an "event" is patented.  This still means little in the commercial realm.  Next the trait has to be "introgressed into elite germplasm," meaning it has to be crossed using conventional breeding methods to get that trait into many of the best hybrids or varieties which seed companies have developed for specific geographies and/or specific uses.  This part of the seed industry is very competitive for the crops which have been engineered to-date.  A company that has developed a new trait has the option of only commercializing in their own seed lines or of licensing it broadly even to their competitors.  Monsanto picked the later path with their Roundup Ready Soybeans, and even though farmers rapidly adopted the technology and used it in over 90% of what they planted, those seeds were purchased from many different seed company competitors whose elite germplasm was every bit as important for the sale as that one trait.

Of course patents have a finite term.  For instance, the key patents covering the original Roundup Ready Soybeans will expire in 2014 and Monsanto will have no future control of those lines.

Patents also don't always block uses.  When Cornell University developed virus resistant papayas that could save the Hawaiian industry, Monsanto gave them rights to certain necessary patents for free.  Similarly, many companies have waived their patent rights for technologies involved in "Golden Rice."

Behind Each Patent, There Are People


Part of why I am so positive about the role of patents in agriculture is that over the years I've had privilege of meeting many of the individual scientists who have been involved in the inventive process of plant biotechnology - the sort of innovations that can be patented.  The people I have met/known have innovated in both small and large companies, in universities and in the USDA and if you met them you would be impressed with both their scientific acumen and their positive ambitions for making a societal contribution.

Cohen and Boyer taught sections of a biochemistry class I took at Stanford in the late 70s.  One of the inventors at Calgene that found the CP4 gene worked in the neighboring lab when I was a graduate student at UC Davis.  One of my previous employers had a partnership with JTI and I met scientists at their plant biotechnology center that came up with the monocot-specific Agrobacterium strain.  I have done projects in which I met several university scientists whose inventions were licensed by the companies that commercialize biotech and other crops.  I've met many of the scientists in the big ag/biotech companies and interacted at various stages of biotech crop development from ideas to full commercialization.  I wish you could meet these scientists.

From what I have seen, the potential of patent protection has been an extremely important driver of creativity and of getting the resources necessary for scientists to be creative.  In every case what I've seen involves scientific rigor, real-world problem solving, and excitement about being able to make a contribution.

I've seen universities get a stream of money to support additional research because of a patent they were able to license.  I've seen small companies reward their staff and investors because of important patents they generated.  I've seen the advanced level of scientific effort that is possible in large companies for whom the potential of patented products allows a high rate of plowing profits back into research - something that does not happen in the companies that sell generic products.

Based on all these experiences, I cannot share the concerns that are being so widely expressed about the role of patents in agriculture.  In fact, I cannot imagine a path forward without them.

You are welcome to comment here and/or to email me at savage.sd@gmail.com

Patent image from Wikimedia commons








15 comments:

  1. This is a great, short backgrounder on how patents have been used in biotech. I had actually thought Monsanto had bought the patents outright for some of the key tech, but apparently I was completely wrong!

    Thanks for posting it.

    ReplyDelete
  2. Many things puzzle me about these arguments.

    First, given all the other forms of intellectual property protection on plants, my own feeling is that patents are possibly too restrictive. At least in the hands of the overly litigious.

    Secondly, all the private enterprises depend fundamentally on government-funded research that produces public goods. They would be utterly unable to develop many of the products that they patent without that prior art. So, just as Garret Hardin explained, they commonize the costs and privatise the profits, a sure-fire way to make a bundle.

    Finally, if it is as hard to get a patent as you say, how on Earth did the Enola bean slip through the system, costing who knows how much time and money for all concerned?

    ReplyDelete
  3. Here’s an alternative perspective to Dr. Savage’s defense of utility patents on biological organisms as a “grand bargain” to society: http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=456

    It certainly offers a counter perspective to the idea “The system forces a level of idea-sharing that would never have happened without it.”…in fact patents on biological organisms prohibit basic scientific inquiry.

    Also, as Richard Jeffries points out many plant patents are far from “novel” inventions: http://blogs.cambia.org/raj/2007/04/03/why-does-a-dog-lick-himself/

    There is also the existing patent on gametophytic incompatibility trait in corn owned by Hoegemeyer Hybrids….even though gametophytic self-incompatibility has been documented in public agronomy journals for over 50 years(Agronomy Journal in 1955: https://www.soils.org/publications/aj/abstracts/47/9/AJ0470090440b).
    But no matter, those organic and non-GE seed companies that want to use the trait to breed organic varieties that are less likely to have adventitious presence of GE traits can just pass the IPR lease costs on to the organic farmer….they get a premium and all. And those public researchers like Major Goodman at NC State, Linda Pollack at ISU/USDA-ARS, Frank Kutka and others who are working on corn with these traits can go to a chiropractor to get that kink in their neck adjusted from looking over their shoulders and wondering when the “cease and desist” letter will arrive.

    Naturally occurring characteristics like Heat tolerance in broccoli (http://www.google.com/patents/US6294715), pleasant tasting melonds (http://www.genet-info.org/information-services/news/en/24220.html) …never thought of that – how novel! Give that man a patent!

    Not to mention that germplasm coming out of NGPS might have “hidden” patents on it. I spoke to Dr. Bretting last week and he affirmed that they are unable to pass on adequate IPR info when researchers ask for samples, and that institutions requesting affidavits that there are no patents on the accessions they receive are told “sorry, we just don’t know that info” — so hurrah for innovation and the public domain!

    But, Dr. Savage might counter, we can always use the legal system to protest patents that we believe were unjustly awarded. Yes, if you have hundreds of thousands of dollars and years of time (Enola bean patent).

    This sport of patenting does not favor those with short arms and narrow shoulders…but that’s Darwinian globalization of the public domain; and that’s ‘natural’ – right? I hear the used car salesman crying out to the masses, “Bargain bargain bargain!”

    ReplyDelete
  4. Matthew,
    There is an academic exception for conducting research on patented inventions. Other companies are blocked from certain activities, but not University folks.

    ReplyDelete
  5. These scientists didn't get the memo about the exception: http://www.nytimes.com/2009/02/20/business/20crop.html?_r=0

    And are you saying if I am a corn breeder at Iowa State University I can breed (conduct research) with plant materials that are protected by utility patents, such as the gametophytic incompatibility trait? Even if I was granted such an exception, what would I do with my research? Could I give the variety away to farmers? Could the university release it? No.

    And please, curious to know your response to abuses in the system such as Jeffries points to, as well as Luigi and my noting of Enola bean.

    Also, I think you overstate the value of the "obligation to teach" for example, when Seminis patents a spinach line (non-GE) they describe the process as such: "Spinach line SMB66-1114F was developed by pedigree selection from a cross of a Seminis parent line "SMB66-27F and the hybrid "COBRA." COBRA is the cross between two proprietary Seminis hybrids, "SMB66-1028F" and "SEB66-16D." The origins and selections that led to the development of line SMB66-1114F can be summarized as follows (S=Selfing, M =Mass selection)"

    In other words "we crossed some proprietary material with some other proprietary material, did some selfing and mass selection." -- How does that educate and add to the overall improved understanding of genetics?

    PVP on finished cultivar combined with controlling parent lines gives plenty of IPR. Cargill and Pioneer made massive gains in corn breeding during the years prior to utility patents....so did they really need patents to innovate, or just to consolidate market share?

    ReplyDelete
  6. Matthew,
    Market share in the seed business is driven by many factors. Who has the best, locally adapted lines or hybrids? Who has the best seed quality (a factor driven by their choice of seed growers and by their post-harvest handling practices? Who offers the seed treatment packages that farmers want? Who has the most competitive prices relative to the offer? Who has the best customer service (e.g. with regard to returns, replanting etc)? Who has their inventory properly balanced with demand? Who has the traits that growers desire? Who has the relationships in small communities. Patents are important, but they don't trump all of that.

    While you are welcome to comment here, this post also went up on the Biofortified site (http://www.biofortified.org/2013/03/a-defense-of-plant-and-crop-related-patents/) and there you might be able to interact with more plant breeders on these questions.

    Also, I don't know the story of the Enola bean. Perhaps you could summarize that so I and others don't have to go searching for that information.

    Thanks,

    Steve

    ReplyDelete
  7. "I don't know the story of the Enola bean"

    Steve, I find this really, really strange. You defend the value of plant patents with what seems like authority, and yet ...

    ReplyDelete
    Replies
    1. Jeremy,
      I looked up the Enola Bean and the reason I have not heard of it is that it involves a rather obscure specialty crop example. The person filing the patent is certainly not from any significant commercial seed company. It appears to be little more than an individual. The novelty claims seemed marginal at best and thus it is no surprise that when challenged in court, the patent was invalidated

      http://law.justia.com/cases/federal/appellate-courts/cafc/08-1492/08-1492-2011-03-27.html

      That decision was handed down four years ago in 2009. As I said in the post, "a patent is only a right to be sued" until it holds up to a court challenge.

      So this is a case of the patent examiner having done a poor job in the first place and of some opportunistic individual that temporarily got a patent. Yet this case is being held up as an example of multi-national companies plundering traditional genetics? Seriously?

      Delete
  8. I do understand just a little about how the seed industry works as well as know plenty of plant breeders (including some of the fine folks who occasionally drop by Biofortified). I'm an advisor to USDA on national genetic resources, have worked in the seed industry and know and work with dozens of private and public sector plant breeders. I have been PI or co-partner on a good handful of USDA funded plant breeding grants - and at present I managed 7 research partnerships with breeding programs at land grant universities (and do a little with AgCanada). I helped coauthor 2007 farm bill language on classical plant breeding. So I know a little about the seed industry, even though I am admittedly without my shiny badge that says PhD.

    I understand your point that there are good people doing good work with patents (no argument there)...but the use of utility patents as a tool for innovation in plant breeding is not serving innovation, it's leading to market concentration (in partnership with contract law from seed genetics firms to seed production firms)...remember 2009 and that two year DOJ/USDA antitrust investigation into ag with a major seed focus, or the 14 state attorney generals investigating? No? yeah, it happened, but few remember it. Christine Varney from DOJ was very outspoken about the linkage (until mid-investigation she mysteriously left DOJ - with rumors swirling around DC that she was to"antitrust" for the Obama administration...not that I am a conspiracy theorist). Patents may not trump all the other factors combined (unless the growers value the patented trait above all other factors) but when all the other factors are relatively similar, patented traits tip the scales towards the company with the traits. If they didn't, why would the companies invest so much in them?

    I listened to over a thousand farmers at DOJ/USDA hearings at six sites across the country testify that the seed industry is indeed overly consolidated (but DOJ won't release that testimony...not that I am a conspiracy theorist...but hey, shit and shinola are pretty easy to distinguish). And I heard a director of research from Pioneer last week in DC saying that corn and soy genetic diversity (allelic diversity of crops planted in the field) in the US is "vulnerable" and that are lack of monitoring these issues is "unacceptable" (I'll send you the public minutes as soon as they are published)...so not everyone thinks patenting has led to innovation and seed market that serves all and has US plant genetics in rosy shape for upcoming challenges.

    Could you speak more to the public exception? And rationalize why "heat tolerance" as a characteristic (not a trait) is patentable? Melon flavor? How about the color yellow in a dry bean?

    Flying Spaghetti Monster help us all if congress doesn't do it's job and examine if UPs are appropriate IPR for evolutionary biological systems. The IPR system isn't broken, it's an abomination.

    I think the folks at Agrobiodiverse might have posted some Enola info for you. I'd do it but I got worn out writing my CV and my conspiracy theories and have to go to work now.

    ReplyDelete
  9. Matthew,
    You obviously do know a lot about breeding and it sounds like you work on important things.

    As for forces driving consolidation in the seed industry, that is also multi-dimensional. One issue the need for access to elite germplasm into which to put biotech traits. Another is the high cost of taking a trait through the regulatory system.

    My memory is that the acquisition of Delta and Pine, the big cotton seed company, was held up until some divestiture because of competitiveness concerns. That was before the one you are talking about. I guess I wouldn't jump to the conclusion that DOJ didn't do their job.

    I don't know enough about the heat tolerance trait you mention, but depending on what it is I can imagine that being patentable. As for better tasting melons I can think of excellent examples of where that makes sense. The Dulcinea division of Syngenta Seeds developed the first "personal watermelon." It was small at a time when the rest of the seed companies were focused on large melons. The breeder did an excellent job of selecting for the trait of having the "heart" extend all the way to a very small rind. None of the following imitations has come close to that quality. Dulcinea also developed a "Tuscan Sweet" melon. It is actually a musk melon, but it looks enough like a cantaloupe that consumers accepted it. In both cases the company also worked out production contracts that reward growers for fruit quality, not just weight which is the norm. They also invested to build the Dulcinea brand. These are the only melons of this type I buy any more because unlike others, I almost never am disappointed in the flavor and thus they don't go bad in the refrigerator (what I call "disappointment shrink" - one of the major causes of food waste). That is a great example of how breeding innovation and system development are fostered by the ability to patent a significant advance in flavor.

    ReplyDelete
  10. I think an important development in the ag biotech utility patent landscape (parallel to the tech industry) is that the big companies now keep giant portfolios of (often tenuous) patent positions so they can wave papers around in court if another company tries to keep them from doing business as usual. I've come across many patents that, in my unprofessional opinion, are obvious extensions of prior art...

    Big companies with full time lawyers can make this system work (maybe), but individuals and small organizations without deep pockets definitely can get a bit stuffed. Companies do need some way to gain limited exclusivity for their products (or else most of all this great government funded basic research will just moulder in journals). I'm not sure what the best balance is, but maybe a first step is to invest a bit more in patent clerks to help them avoid some of the abuses mentioned above. You shouldn't have to sue a globe-straddling MNC to make something useful in your little corner of the world.

    ReplyDelete
    Replies
    1. Maybe it would be a good thing to have something like a public comment period on patents. The problem is that there are so many applications, I don't know who would keep up with them. Again, the Enola bean thing is not an example of an abuse by an MNC. Show me an example from them and I'll be more concerned.

      Today I saw dry beans for sale in my local, ordinary grocery store called Peruano beans. They were sort of yellow. How does that relate to the Enola thing?

      Delete
    2. Matt, is different than Matthew. (Hi Matt!)

      Here's the yellow bean info: http://www.patentlyo.com/patent/2009/07/mexican-yellow-bean-patent-finally-cooked.html

      You might also be interested in Phil Pardey's work from Univ of Minnesota (Nature Biotechnology, January 2013) that showed that 3 firms were responsible for 74% of utility patent applications between 2004-08.

      Delete
  11. The Nunga "popping bean" was another case similar to the Enola bean: http://www.greenleft.org.au/node/25113

    http://naturalscience.com/ns/news/news38.html

    ReplyDelete

Please send comments if you wish. Sorry about the word verification, but I'm getting tons of spam comments