On February 19, the Supreme Court heard the oral argument in Bowman v. Monsanto on the application of patent exhaustion to patented self-replicating seeds.  Under the doctrine of patent exhaustion, “the initial authorized sale of a patented item terminates all of the patent owner’s rights in that item.”  Monsanto holds a patent on a gene which makes plants resistant to glyphosate herbicides.  Farmers use the herbicides on weeds and when using Monsanto’s seeds, has no effect on the plant.

Monsanto sells the herbicide resistant seeds to farmers and licenses the technology to seed producers.  As a condition of sale, all purchasers of the first generation seed must agree to limit the use of their seeds and the technology to a single season and cannot replant the second generation seeds.  This is because through the acts of nature, the herbicide resistant-trait is passed down to each successive generation of seeds.  However, Monsanto does allow farmers to sell the second-generation seeds (restriction free) to local grain elevators as animal feed or commodity seeds (which are purchased for various uses including planting).  Bowman purchased seeds from a local grain elevator and planted them as a second crop (the latter act in double cropping), later discovering that some of the commodity seeds he purchased, included herbicide-resistant seeds.  While Monsanto purchased first generation seeds from a licensed retailer for his first crop, he continued to use the seed offspring of his second crop supplemented with additional commodity seeds during subsequent years.

Monsanto sued Bowman for patent infringement of two of its patents.  Bowman argued that under the doctrine of patent exhaustion, Monsanto’s failure to restrict the authorized sale of second-generation seeds rendered its patents exhausted with respect to the use of that seed.  The district court disagreed, and the federal circuit affirmed, finding that Monsanto’s patents rights in the seeds were not exhausted once sold to a commodity dealer; and that the patent covered the technology of the original seed and all products of the original seeds.  In principle, the federal circuit basically held that patent exhaustion does not apply with respect to self-replicating technologies.  Bowman’s main argument is that the patented seeds were bought to be planted, and the expected and natural use of the product of such seeds is to be planted.  Any patent rights Monsanto had with regard to the sale of its seeds was exhausted with the sale of its second generation seeds without restriction to the grain elevators.  Monsanto claims its patent is on the trait (herbicide-resistance) and therefore seeds containing the trait are covered by the patent.

In a 2008 case involving Intel chips licensed from LG, the court held that once the chips were sold to computer manufacturers, LG’s rights were exhausted.  The case here is different as it involves not only a self-replicating invention, but an invention which self-replicates through mechanisms of nature.  Based on the oral argument, it seems the justices have taken the side of Monsanto.

However is it really the role of patent law to restrict the use of subsequent seed generations that were a known, natural byproduct of an authorized sale?  Or is this really an issue which would be better addressed by contract law.  Monsanto argues that a decision in favor of Bowman would “eviscerate patent protection.”  Couldn’t Monsanto structure its contracts differently or in a more effective matter in order to prevent farmers like Bowman from saving and using subsequent seed generations for planting?

Chief Justice John Roberts asked “Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?”

Since when does a patent on an innovative invention guarantee a successful marketable product or a return on your investment?  Why should the court create a special exception to a long-standing doctrine to simply accommodate Monsanto?  Monsanto knew what it was doing when it entered the seed business.  Seeds grow into plants, plants produce seeds.  One could reasonable argue that Monsanto should have taken account for the qualities and characteristics of its own “invention” when marketing its product.  Monsanto argues that Bowman’s use of progeny seed is equivalent to making illegal copies of an invention.  Bowman isn’t taking the seed and making an exact copy of the seed.  The seed makes a plant which makes more seeds; this is the nature of the seed, and the natural use and purpose of the seed.  Couldn’t Monsanto modify its gene in a way which would not allow for subsequent generations of seed to maintain the herbicide-resistant trait (effectively making “sterile” seeds)?

Regardless of the justices’ decision here, the holding can potentially raise a broad range of implications and questions.  What happens when Monsanto seeds blow onto another farm…does that farmer then become liable for infringement?  If a grain elevator unknowingly sells Monsanto seeds, is the grain elevator infringing?  Some argue that a decision for Monsanto may increase monopolies and make it harder for the consumer to bring anti-trust suits.  Others argue a decision for Bowman has a negative impact on innovation and research in the seed market, cause an increase in price on the sale of seeds, and have an impact on the protection of patented software (which also has the ability to self-replicate).  We hope to have the answer to some of these questions by June.

Background of Cerebral Palsy

Cerebral palsy is a neurological condition characterized by abnormal movements, muscle tone, or posture.  It is caused by a brain injury or abnormal brain development, most typically during pregnancy, but some cases arise in infancy or very early childhood.  The underlying injury is permanent but doesn’t worsen over time (non-progressive), so the person’s symptoms are relatively the same throughout their life.  Common symptoms include: poor muscle coordination during voluntary movements, such as reaching for things; abnormally stiff or floppy muscle tone; spasticity, which means exaggerated reflexes or too tight muscles; and an abnormal gait, such as dragging one foot, walking on toes, or a “scissored” gait.  Many people with cerebral palsy also suffer from other conditions related to developmental brain abnormalities, such as excessive drooling, difficulty eating and swallowing, seizures, and intellectual disabilities.

There are a variety of treatments for cerebral palsy, but there is no cure. Most treatments are “disability management.” The available treatments typically aim to minimize the symptoms of cerebral palsy and improve the person’s functional abilities. This includes medication, physical and occupational therapy, surgery, and speech therapy.  Assistive devices such as wheelchairs, walkers, and computers with attached voice synthesizers play a critical role in treatment of cerebral palsy.

Robotic Limbs and the Americans with Disabilities Act

Hugh Herr—the same roboticist mentioned above—suggested at a recent conference organized by the Economist that we may soon see people opting to amputate limbs in order to replace them with higher functioning robotic ones. People with cerebral palsy are one population that may be interested in taking such a drastic step.  Some people with cerebral palsy experience symptoms throughout their entire body, while others’ muscular coordination disabilities affect only one side of their body or are isolated in one limb. Those individuals with isolated symptoms could replace the affected limb.  If Mr. Herr’s prediction is taken to the extreme, individuals who experience spastic movements throughout their entire body may be able to replace all of the affected nerves and enjoy smooth coordinated movements.

If people with cerebral palsy opt to replace limbs or more, will their disability be eliminated in the eyes of the law? The answer turns on how disability is defined.  As the law stands now, to qualify for protection under the Americans with Disabilities Act (ADA), a person must meet the statute’s definition of an individual with a disability: “a person who has a physical or mental impairment that substantially limits one or more major life activities, … a history … of such an impairment, or a person who is perceived … as having such an impairment.” The ADA is a civil rights law that aims to protect people with disabilities from discrimination and to ensure that they have access to public services and benefits. Individuals’ status as “disabled” under the ADA is determined on a case-by-case basis.  Being labeled “disabled” comes with complex social and legal consequences and benefits. Accordingly, it is not clear whether those people whose disabilities have been ‘eliminated’ would want to continue to be considered disabled. Further, whether people should be permitted to retain their “disabled” status under the ADA after a functional “elimination” of their disability is a legal, political, and ethical conundrum. Two elements of the ADA’s definition appear to preserve those individuals’ option to retain their “disabled” label under the ADA—the “history” and “percieved … as having” criteria.  Accordingly, the ADA’s current definition decreases the likelihood that Mr. Herr’s prediction is correct. .

The “history” portion of this broad definition seemingly permits a person who has adopted a robotic limb to continue to be considered disabled. Thus, as long as the definition includes “history,” Mr. Herr’s prediction that disabilities will be largely eliminated cannot come true under the ADA.  This suggests that it may be time to rework the ADA’s definition, a difficult task. At what point would it be proper to consider a person no longer disabled, despite their history? One lawyer-bioethicist argues that existing mobility assistive devices, such as wheelchairs, should already be treated as part of the owner’s body under the law in the event that a third party harms it.  But should that argument work in reverse? Once a device that permits its user to function at the same level as people who don’t have histories of disability can be fairly considered part of the body, should that user no longer be considered disabled? How integrated into the body would that device need to be? As assistive technologies become more lifelike and commonplace, it seems that the definition should be changed to make way for a future in which disabilities can be considered largely eliminated.

The “perceived… as having” portion of the definition poses an additional barrier to actualizing Mr. Herr’s prediction. For example, if a person suffers from multiple symptoms or disabilities (like most people with cerebral palsy) how many of their symptoms would need to be ‘cured’ by robotics for that person to no longer be considered disabled? What would happen if a person with cerebral palsy no longer had spastic muscle movements in their arms thanks to robotics, but continued to suffer from the characteristic tongue thrusting or facial symptoms such that others could identify them as someone who suffers from cerebral palsy.  However, given the powerful effect of stigma, whether it would be appropriate to remove that portion of the definition is loaded issue that regulators must approach extremely cautiously.

The definition of “Disability” and Legal Autonomy

A person who is considered disabled from a legal autonomy perspective is someone who lacks legal capacity to perform certain acts.  For example, a person with a communication disability or an intellectual disability as a result of cerebral palsy may not be able to perform the legal acts of communicating consent or making decisions about finances.  Such persons are often appointed guardians or other advocates who assume responsibility for their legal decision-making.  However, as assistive communication devices are improved and become more popular, fewer people with cerebral palsy will require legal proxies or those proxies will play a smaller role.  Helpfully, the Model Rules for Professional Conduct have already established a good precedent for accommodating those changes. The rule for assisting clients with diminished mental capacity requires that a lawyer try to involve the client as much as possible, and to frequently reassess the client’s capacity to make independent decisions.

So, Mr. Herr may be right with respect to disability in the legal autonomy context. For people with cerebral palsy who are disabled because of physical communication impairments, advancements in and increased popularity of devices like the ECO2, a form of “augmentative and alternative communication” (AAC) that creates verbal speech from the user’s head movements, may very well eliminate their disability. Brain-computer interfaces are an even more advanced form of the same idea. Further, people with cerebral palsy who have less legal autonomy because of an intellectual disability (approximately 40% of people with cerebral palsy suffer intellectual disabilities) may enjoy greater independence thanks to technology that promotes early child language development.

Conclusions

New developments in assistive technology will transform the lives of hundreds thousands of people with cerebral palsy. These inventions are changing the way people with disabilities live, as well as how our society thinks about disabilities.  The European Commission (EC) has recognized the need for European law to adapt.  To that end, the EC is funding RoboLaw, a large-scale research project to investigate the interplay between European law and emerging robotic technologies. This was a brief and narrow assessment, but it revealed that whether technology can successfully eliminate disabilities depends in part on the definition of disability in U.S. legal system.  The U.S. should follow Europe’s lead and begin investigating the best way to restructure its laws as well.

The nonobviousness and written description requirements set forth in sections 103 and 112 of the Patent Act provide additional and, some argue, more effective filters for claims directed towards genetic material. According to some academics, these requirements have been much further developed in the case law, are more finely tuned to address patents on genetic material, and provide more appropriate filters for separating truly inventive additions to human knowledge from unpatentable matter. Two landmark cases illustrate how these requirements have been used to invalidate claims directed towards genetic material.

First, the Federal Circuit invalidated patent claims for failing to meet the written description requirement in Regents of the University of California v. Eli Lilly & Co. The patent specification described cDNA encoding rat insulin, which the court held did not give the patentee a right to also claim the cDNA encoding human insulin. The court emphasized that even if the disclosure was sufficient to enable a person of skill in the art to make and use that cDNA, it still failed to meet the written description requirement. On the other hand, the court noted, a recitation of the actual nucleotide sequence would suffice. As some scholars argue, the requirement so applied compels applicants “to spell out the exact sequence of all the DNA they hope to claim, rather than just the function of the genes.” Denise DeFranco argues that the primary goal of applying the requirement in this way to biotechnology patents “is to limit inventors to their actual inventions.” Indeed, at the time the Plaintiffs in Eli Lilly applied for the patent claiming human insulin, they had only cloned the rat insulin gene, and did not clone the human insulin gene until two years later.

In another significant biotechnology case in 2009, In re Kubin, the Federal Circuit invalidated patent claims on obviousness grounds. The case involved a claim to the isolation and sequencing of a gene encoding a protein domain known as NAIL. In light of the prior art references, which taught a prophetic method for isolating the gene that codes for the NAIL protein as well as a probe specific to the protein, the court held that the claims were invalid. Prior to this holding, similar patents had been upheld even when the prior art included as much or more information as that considered in Kubin, such as the actual polypeptide sequence of the protein at issue and not just a probe for the protein. This decision has thus been characterized as “a major change in the law that will lower the bar for finding biotechnology patents obvious.” Joanne Kwan postulates that following Kubin, biotech inventions such as claims to isolated genes that encode particular proteins may now be routinely invalidated as obvious under Section 103.

This post does not comment on the social desirability of allowing patents on genetic material, nor on the legal merits of the arguments in Myriad. Rather, it seeks to highlight that the question raised by the patentable subject matter challenge in Myriad is a narrow one, a “coarse eligibility filter” in the words of the Federal Circuit. The Patent Act provides a number of other requirements to ensure that patents on genetic material aren’t improvidently granted when, for example, the inventors have not actually cloned the gene they are claiming, or when the protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions for cloning the gene already exist in the prior art. Regardless of the precedent ultimately set by Myriad, these and other additional statutory requirements will continue to have a significant impact on the validity of patent claims directed to genetic material.

The Prometheus patents covered the concept of adjusting the dosage of thiopurine drugs based on the level of metabolites in a patient’s blood. The patents on the thiopurine drugs involved have long since expired and the patents in question claim no specific method for measuring the metabolite level in a patient. The now invalidated claims had two steps. The first step was simply the administration of the drug. The second step was the measurement of the metabolite in the patient after the administration. The remainder of the claim describes the correlation. If the metabolite concentration is higher than a certain value, this “indicate[s] a need” to reduce the next dose and vice versa.

The Mayo Clinic used the thiopurine metabolites test developed by Prometheus until 2004 when it developed its own test. Prometheus sued Mayo in 2004, alleging that the patents covered more than just the particular test that Prometheus had developed. Prometheus argued that the patents covered the entire process in the claims without any restriction to a particular method of administration or measurement. In effect, this prevented anyone else from making use of the correlation between certain metabolite levels and drug dosages however the patents were allowed as applications of this correlation.

The district court held that patents were invalid under §101 because they claimed scientific correlations which were natural phenomena that resulted from natural body processes. However, the Federal Circuit overturned this ruling and upheld the validity of the patents. The Federal Circuit relied on the machine or transformation test in coming to its decision. Understanding that the machine or transformation test is only a “useful  and important clue, an investigative tool,” the Federal Circuit held that the steps in the claims comprised a method of treatment which was a proper application of a scientific principle. In addition, the Federal Circuit noted that the method of treatment claimed in the patents satisfied the transformation prong of the machine-or-transformation test. Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 1355-57 (Fed. Cir. 2010).

The Supreme Court started its analysis by noting that the relationship between the concentration of metabolite in a patient’s blood and the efficacy of another dosage of the thiopurine drug is a law of nature that is not patentable. The relationship itself is simply a consequence of how the metabolite interacts with one’s body in a way that is separate from any human action. Thus, to be patentable, the claims have to contain additional features that conclusively show that the process applies the law of nature.

Identifying three additional features in the Prometheus patents, the Court found them all to be insufficient to deem the process an application of a law of nature. The first feature, the administration step, was dismissed as only identifying the people interested in the correlation. Specifically, the people interested are doctors using thiopurine drugs and this group existed before these patents existed. The measuring step does not make this claim patentable because the methods of measuring metabolite levels are well known in the art. Telling doctors to engage in routine, well known activity does not make this process patentable. Lastly, the explanation of the correlation adds little to the actual application of the process and just describes the law of nature. At most, it suggests that doctors should consider the test results when deciding the next dosage of the drug.

Because the features in the Prometheus claims were simply drafting efforts rather than substantive additions, the Supreme Court struck down the patents. However, the Court did not shed much light on what exactly constitutes an additional feature that would demonstrate an application of a law of nature. Finding the three additional features in the Prometheus claims to be insufficient gives some guidance, but no other specific explanation was provided.

• Patent Docs reviews Senator Patrick Leahy’s proposals for patent reform.

• Third Circuit gives “Spam filter ate my filing notice” excuse a second chance, from the Technology & Marketing Blog.

• EFF sues to find out how the government spies on us using social networks; Indiana University students makes a Freedom of Information request to find out much the big telcos charge the government to spy on their networks, says Wired.

• The New York Times opines in favor of the Empire State’s decision to collect sales tax on online purchases from out-of-state retailers delivered in New York.

• Lazy IP enforcement leads to prosecution of the wrong guy, who makes a big deal out of it, says Ars Technica.

• FTC isn’t done with Intel yet, now looking into anticompetitive behavior with regard to Nvidia, reports BusinessWeek.

• Google to end free access to subscription news, blogs Gizmodo.

• And for an international perspective: BioTechBlog reports on IP and the biotech industry in India.