Tobacco may Help Diabetic Patients in the Future

SemBioSys Genetics Inc., out of Canada, was granted U.S. patent number 7,547, 821 entitled"Methods for the Production of Insulin in Plants". A similar patent was granted in Europe last year, and there are patent applications submitted in a multitude of countries worldwide according to the official company press release. The ever-increasing obesity problem that is facing the United States virtually guarantees great success on the patent as plant production is considered the fastest and cheapest methods of reproducing proteins. They will have a lock on the commercialization processes of this plant production method, I bet you wish you would have wanted to know this before its IPO last week.

From the abstract of the Patent "Production in seeds offers flexibility in storage and shipment of insulin as a raw material, and insulin retains its activity upon extraction from stored seed. Further, the amount of biomass subjected to extraction is limited, due to the relatively low water content of plant seeds." The benefits also include the cost factor in production as the scientists do not have to spend tons of money on generating the proteins within labs in small quantities. There is one aspect of the work that seems to worry me based on language in the patent. The claims of the patent seem to use tobacco, as it is typically an easy plant to use due to its regeneration and large pours that let you pop those proteins right out of the leaves in a vacuum chamber. However, it seems that the inventors would prefer to use the Arabidopsis (first plant that had its genome sequenced due to its simplicity), flax plant, or safflower. I am not sure the reason to steer away form tobacco, as it works well in demonstration scale tests, but perhaps its the perception, cost, complexity of the plant, or a host of other factors in which a learned expert in science or business could provide illumination.

This preference for other plants besides the Arabidopsis concerns me, as I believe it will give it a tougher time through the regulatory channels that transgenic crops must go through with APHIS and FDA. No one is much on tobacco, even smoking "unprocessed" tobacco is odious and the demand for consumption of Arabidopsis is virtually non-existent, so there would be no concern of these seeds getting into the food supply as there is no channel for these seeds. However, flax is being used more and more as an alternative to "traditional" foods with its presumed or known health effects, and safflower is used in vegetable oil and salad dressings. I believe this could cause more obstacles than need to be there during the regulatory phase as well as the possibility of public relations problems. This push-back from segments of the public can be seen in the opposition of corn's usage in pharmacropping.

I will continue to follow the progress of this company's patented invention as it continues its clinical trials and comment on the legal steps it will take and possible ramifications of actions taken while attempting to install it into the commercial chain.

I want to comment, and give credit, on where I get my base information to run off with into fanciful flights of legal discovery and opining upon all things seed. Please visit SeedQuest as they provide far more of an overview of the seed industry than my blog ever could, as they should. Another great resource for topic ideas and the most comprehensive blog regarding the extremely broad field of agricultural law is a combined effort of the National Agricultural Law Center and the American Agricultural Law Center, which can be found here.

-Craig

When can a Farmer Legally Save Seed?

This post was inspired by a news report on Seedquest and a portion of the movie Food, Inc. that focused on Maurice Parr a traveling seed cleaner in the Midwest that was accused of assisting in the unlawful resale of patented seeds. Many people are attempting to save seed in these economic times as a way to cut cost, however there is some considerations you have to keep in mind regarding the legality of that action especially as more groups are enforcing their rights through U.S. patent laws or the Plant Variety Protection Act (PVPA).

In regards to patented seeds these are typically protected as Utility Patents, administered by the USPTO, which allows the patent owner to exclude others from making, using, offering for sale, selling, or importing, the protected seed for a period of 20 years. Diamond v. Chakrabarty, 447 U.S. 303 (1980), broadened the scope of patentability to "anything under the sun that is made by the hand of man," which included living organisms. An asexually reproduced plant, excluding tubers, can also be protected by a Plant Patent, also administered by USPTO, which gives the patent owner the right to exclude others from reproducing, selling, or using the plant for 20 years. The defenses, such as the experimental use exception, to patent infringement are narrowly tailored and will typically require great expense to present, so you are better off not attempting to save this seed at all. The main thing the farmer needs to know is the contract or license language that prohibits the saving of the seed, which should be heeded as any violation of this will constitute a breach of the license and actionable infringement.

The Plant Variety Protection Act, administered by the USDA, offers two exemptions to the granted exclusive rights of the certificate holder. The PVPA covers sexually reproduced seeds that are "new","distinct","uniform" and "stable", and grants the certificate holder the right to exclude others from selling, marketing, offering for sale, reproducing, consigning, exchanging, importing or using a variety in the production of a hybrid or different variety for 20 years. One exemption to the exclusive right is for breeders or researchers to use the seed in developing a new variety, and the other exemption is for farmers to save seed for replanting if they lawfully purchased the seed. This latter exemption does not give the right to resell the protected seed, but only for replanting for personal use, or get one "off the hook" for purchasing unlawfully sold seed. Please see the ways to identify the PVP seed has been certified and lawful by the Kansas Crop Improvement Association here.

Note: Please be careful, as US law allows double protection through a patent and PVPA certificate if the owner desires and the "invention" qualifies.

The saving of seed of the now limited Public Varieties, is of no consequence to the farmer as they are not afforded any protection unless there was some contract the farmer may have entered into himself for the purchase of the seed. However, this is highly unlikely. This seed can be saved, but please remember practical considerations such as the germination rate that will be of value to you that can be checked at the State Seed lab (Some states its an independent body, university, or the Crop Improvement Association) or can be handled by seed cleaners, like Maurice Parr, who will have the germination checked, clean out the debris from your seeds, and bag it for you.

Please remember form previous posts located on this blog that public varieties are much more limited, as research budgets have swell at the universities as the demand for technology has increased in the recent years, thereby increasing the amount of varieties gaining protection. In addition, groups that traditionally were not enforcing their rights are now beginning to bring suit and enter into hefty settlements as money is thinning.

To avoid potential trouble, please do a little homework on where you got the seed, whether it is protected, and what kind of protection the seed has: patent or PVP certificates, or both. In addition, check any contract you may have signed and its provisions regarding left over or second generation seeds.

More on KSU Plant Variety Protection Infringement Settlement

I mentioned in last week's post regarding a lawsuit filed by South Dakota State University over wheat varieties, a lawsuit that was settled between the Kansas State University (KSU) and defendant farmers. I stumbled upon an article from the Salina Journal of Salina, Kansas that goes into the situation a little more in-depth and I wanted to add a little commentary.

Once again the central tenet behind these large research universities bringing suits is the frustration of neighbors who see the perpetrators as stealing from the community chest. This community chest is funded through public dollars and payments into the Wheat Checkoff program, which has recently gone up to $0.015 per bushel and should generate about another $1.5 million from wheat farmers. This money is needed as states across the country become cash-strapped and the technology demand is increasing in wheat. The overall spending by the University of its budget has went up 3% to 11% over the past 10 years, but the state funding has not been able to keep pace.

An interesting point in the Salina journal article was that some believe that the payments through the checkoff program brings about the mentality that "I already paid for it, so I should be able to do what I want with it." I hope this is not true, since we have all been conditioned to make our annual penitence payment to the IRS and do not demand to be able to do what we want with the public goods such as roads or parks. Through this and other actions of paying taxes, we as a society get the point that somethings you "pay" for are not exclusively yours to exercise your control over at the expense of others.

The increases in expenses and the ability for to make a profit to dump back into research has led many research universities to have closely connected businesses that they will grant exclusive rights to commercialize or outright assign the patent or plant variety protection certificate. This allows for money to be made by the University through the assignment of contractual rights and by a company who now has the right to commercialize and market the technology. It is in these steps that may get many farmers in trouble, as many research universities once upon a time exclusively put out public varieties, which can still be done today after the PVP certificate or patent expires. This was done as the University was to be working in the public trust and therefore should disseminate the product to whoever wants it.

Due to different times and circumstances, I personally believe that this can still be said, the Research Universities are still protecting the public trust through legal protection of their seeds. The legal protections allows a profit to be made, which allows the University research foundations to fund new wheat varieties that can be funneled back out to the farming community. The brown-bagging of seeds could raise the cost, but it could potentially stall research, hence why these certificate owners must protect the varieties and many will contractually hold themselves to do so through exclusive licenses. These actions benefit the farming community as a whole, despite the ugly sound of an organization that works on behalf of the citizen and citizen farmers suing the one of those citizen farmers. In the instant litigation, the complaint alleged that the unauthorized selling of the protected varieties could have led to the harvesting and replanting of 4 million fifty-pound bags of seed within five generations. That is evident how the theft of this technology can put a huge hindrance upon the ability of the creator to generate money upon its invention to make more inventions, much liked a leaked copy of a movie on the Internet will decrease the income of the production company upon the opening in the theaters.

As for the case itself, the details of the settlement, which occurred within a month of filing, were not de minimis in any sense as the the Stockton, Kansas farm family settled for a monetary award of $150,000 with the Kansas Wheat Alliance, Kansas State University Research Foundation and WestBred, LLC who had joined the case as a co-plaintiff due to one of its seed varieties also being sold without authorization. In addition, according to Seedquest, the defendant farmers gave the right to KWA and WestBred (now a Monsanto Co. after a recent acquisition) the right to inspect all of the family farm business and farming records and premises for the next 3 years for possible violations. If any violation is found, the farmers must pay $35.50 for every 50-pound unit of seed they sell. This creates a liquidated damages clause for any future violation and creates a probationary period for the Stockton, KS farm. This will reduce cost on any future claims that may have to be brought on behalf of the Plaintiffs,.

There is an educational effort being brought together by multiple partners regarding protected varieties through the Farmers' Yield Initiative - check it out.

Monsanto not the only one suing over IP rights

There seems to be constant controversy over larger companies suing farmers for intellectual property infringement, however, Monsanto and the big boys of seed are not the only racing to the courthouse anymore.

A lawsuit was filed today in Sioux Falls, South Dakota by South Dakota State University claiming that five producers violated its plant variety protection (PVP) certificates on spring wheat varieties Traverse and Briggs by knowingly selling or offering to sell without authority, a seed dealer's license, or proper seed certification. This practice of reselling seed is also known as brown-bagging and is violative of the PVPA as the farmer is selling seeds that he does not have permission to sell. Other large research universities, such as Kansas State University, Colorado State University, Oklahoma State University, have been more dogged in enforcing their IP rights through PVP certificates or patent protections, claiming that the proliferation of brown-bagging is leading to a decrease in research funds thereby hurting the dependent farming community as a whole.

These lawsuits are serious matters, as one lawsuit in Kansas resulted in a $150,000 agreed judgment against a producer. It also does not curry you favor with many neighbors who believe you are holding up research on new technology coming out of the large state-run universities that will work with the Crop Improvement Associations in providing limited amounts of public seed.

Interestingly, but not connected in anyway, these lawsuits come on the heels of Monsanto delving further into the wheat world by acquiring a smaller company Westbred in the Upper Midwest. I only mention this, because there probably would have been more of a public outcry if these producers alleged to have brown--bagged seed were sued by one of the larger seed/chemical companies.

Companies, institutions, people spend money, lots of it in many cases, to bring a product to market whether it be for purely profit or innovation's sake. Virtually all will file for protections that have been created by our Constitution or by statute in order to protect their right in the product from someone who did not put the time and money into research. No matter the size, or policies one may believe in regarding IP rights whether on products or life forms, the right to protect your property through the courts is fundamental to our economy and society. Actually, the reason for allowing suits for conversion (civil theft essentially) was to avoid the result of individual's taking justice into their own hands or being bullied by the offender. In that mindset, ironically, one of the most civil and socially acceptable actions you could commit in our society is by taking a dispute to the Courts.

Regardless if you are South Dakota State University, Monsanto, a small seed company, or the guy/girl that created the slap-chop on late night infomercials it is important for that individual or company to enforce any IP property rights that they took the time and trouble to obtain through these suits in an effort to keep structure in the system, as well as deter others from stealing someone else's idea. I understand its not always black and white in these situations, and that the majority of individuals or farmers are not committing these violations, but it is important to send a message to that very small minority that are causing a loss of money to research and undermining a private property system.