Monsanto, Seeds, Software, Self-Replication, and the Supreme Court

As I read the Supreme Court’s unanimous opinion of Bowman v. Monsanto Co. from May 2013, I became interested in seeds and self-replication.  The case involved a farmer, Bowman purchased Monsanto’s Roundup Ready soybeans each year from an authorized dealer.  Bowman had a license with Monsanto to use the Roundup Ready seeds, but he could not use the seeds that were produced from the original plants that were produced from the Roundup Ready seeds. Every season, Bowman purchased soybeans from the grain elevator and planted them for his second crop. Additionally, he would save some seeds from this second crop and use them in the following season.    This where Bowman ran into trouble. Many of the soybeans at this grain elevator came from Roundup Ready seeds and thus, some of seeds from the second crop came from Roundup Ready seeds. Monsanto investigated and the infringement suit against Bowman ensued. Justice Kagan wrote for the court and said the decision only applied to this case and it was determined that Bowman did infringe on Monsanto’s Roundup Ready seed patent. The patent for the Roundup Ready seeds was not exhausted. Kagan concluded that, “Bowman planted Monsanto’s patented soybeans solely to make and market replicas of them, thus depriving the company of the reward patent law provides for the sale of each article. Patent exhaustion provides no haven for that conduct.”

After reading this case, I was interested finding out more about self-replicating technology and when patents of this self-replicating technology are exhausted.  For software and life sciences technology, the answer of when patent exhaustion occurs may be different than the genetically modified seeds. I read an article, from the Life Sciences and Law & Industry Report (TM) by John T. Aquino, entitled “Protecting Self-Replicating Tech Inventions Requires Attention to Claim Drafting, Licensing Contracts, Panelists Say.” Aquino’s article details a webinar held on August 20th that had panelist from Washington law firms discussing the Supreme Court’s decision in the Bowman case. Christopher E. Jeffers, from the firm Wombly Carlyle Sandridge & Rice, mentioned in the article that post-sale restriction enforcement have not been fully addressed by the Federal Circuit nor the Supreme Court.

It is difficult for a company to determine if its patents are exhausted after the first replication.  After Bowman, it looks like licenses may be the best option for companies trying to protect patented self-replicated technology from unauthorized use and infringement. This is how many software manufacturers limit use of their software. In these licenses, the patent holder may stipulate that the holder as licensor can audit the licensee to make sure the license agreement is not being violated.  This is also a good idea for all self-replicating technology in order for the licensor to have some way of possibly knowing if its patents are being infringed. The licensee may be less likely to engage in infringement if the licensee knows that the licensor can audit the use of the patented technology.

The issue of self-replication technology patent exhaustion and post-sale restrictions will remain murky until the Federal Circuit or the Supreme Court provide a definitive answer. With the increase of self-replicating technology, this case may come soon.

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The Case of Myriad and Gene Ownership

On June 13, 2013, the United States Supreme Court decided the case of Association for Molecular Pathology v. Myriad Genetics, Inc. This case has put to rest for now the controversial issue of whether isolated deoxyribonucleic acid (DNA) sequences can be eligible for patent.

Myriad Genetics has several patents for isolating DNA sequences based on its discovery of the location of specific genes.  These genes are known as BRCA1 and BRCA2 and are responsible for tumor suppression. If a woman has specific inherited mutations in BRCA1 and BRCA2, then she will be at higher risk of developing breast and ovarian cancers.  A woman who has the BRCA1 has around a 60 percent risk of developing breast cancer and almost 40 percent chance of developing ovarian cancer.  With the BRCA 2 mutation, a woman has a 45 percent chance of getting breast cancer and around 15 percent chance of getting ovarian cancer. Myriad developed a test called the BRACAnalysis for determining if a woman has these inherited mutations. It should be noted that Myriad made no changes to the DNA of BRCA1 or BRCA2.

The question before the Supreme Court was whether DNA could be patented under the current patent statute.  The Supreme Court held that Myriad did not create a “new composition of matter” and thus, its discovery of BRCA1 and BRCA2’s locations were not patentable. However, synthetic DNA known as cDNA could be patented because unlike the isolated DNA, it was not naturally occurring. The patentability of cDNA will add another dimension to research and development of genetics testing because now the these companies will have to isolate a gene and create a synthetic version of it.

I believe that the Court was correct. In regards to research and development related to DNA and medical advancements, companies will have to create synthetic DNA in order to have it patent eligible. This will cause added expense, but if the companies believe that there is profit to be gained from this patent, I think companies will spend the additional research and development costs.

This ruling will make tests like BRACAnalysis more available to the public because other companies besides Myriad will be able to locate the DNA involved in mutated genes and create tests for determining if patients have these mutations.

Who owns my genes? According to this ruling, I still do.

NFL Concussion Lawsuits Settled

As the college football season begins this weekend and the National Football League starts play next weekend, a settlement of $725 million for concussion injuries suffered by former players is awaiting approval by the United States District Court of Eastern Pennsylvania. The settlement comes two months after mediated negotiations and will settle all pending lawsuits on the matter that involves over 4,000 retired players and their families.

This settlement comes after many years of controversy regarding neurologic injuries caused by playing years of football.  Scientists have been finding that impacts to the heads of football players from the brutal hits taken each time they take the field cause repeated concussions and less serious brain injuries known as “sub-concussions.” These concussions may lead to dementia and chronic traumatic encephalopathy or CTE.  Young players with CTE experience problems involving mood and behavior.  As the players age and continue to play football, they will experience confusion, memory loss, and depression.  Most players do not realize they have CTE until near the end of their football careers after playing the sport since elementary school. There is still not much known about CTE especially its relationship with Alzheimer’s disease. Some people, such as Malcolm Gladwell, have gone as far to say that college football should summarily be banned due to these health concerns because the effects of CTE begin as early as the players’ college years.

The $765 million settlement includes $675 million for compensation of former players who suffered from neurologic injury, $75 million for baseline medical exams, and $10 million for research and education funding. With the inclusion of attorneys’ fees, the NFL will pay over $1 billion for this settlement.

Football and other contact sports will be changed by this ruling. Every year the NFL and college football have seemed to add additional guidelines for football players with concussions. It does not seem to be preventing CTE or other chronic brain injuries. Players will have to stop playing the sports longer after a concussion. There likely will be more monitoring of players’ brains while they play the sports. The technology is improving. Helmet technology have also improved and will continue to improve especially after this agreement.

Rules in contact sports will change. I do not believe that it will be as dramatic as eliminating special teams in football. Not all head injuries occur at kickoff or punt return. It is also extreme to ban contact sports like football for elementary-age children up to college-age students. There needs to be better safety rules in place with better helmets. With new technology and more studies, this will be possible. Contact sports always will have an element of risk, but there is no reason why the sports cannot be made safer.

Many players believe this is a step in the right direction, but still more needs to be done. Even after this settlement, there is concern for the health of current and future football players

Argumentum ad Monsanto

People are often hostile to science. The fruits of the scientific process–new, valid, reliable knowledge about reality–often contradict deeply-held beliefs, and these contradictions can shock the psyche. The mind tries to integrate new information with old. When that information is contradictory, we tend to reject the new information in favor of what’s already integrated, and we sometimes use logical fallacies to justify this rejection.

This self-defense mechanism of the psyche can be very useful. When our existing store of information about the world is built on reliable evidence and sound logic, we are able to spot and reject the patently ridiculous; for example, people with even a rudimentary understanding of chemistry or medicine probably won’t waste their time and money on homeopathic remedies.

On the other hand, if our existing store of knowledge is filled with horsefeathers, poppycock, and other assorted nonsense, we tend to reject information which is evidence-based and logical. And our brains will engage in all sorts of bad behavior to justify the rejection of good information when it contradicts existing bad information.

Take, for example, a certain kind of critic of genetically-modified organisms. You know the type: they’re very vocal about their vegan, gluten-free, organic, locally-sourced, free-range diet, and how “Monsatan” is threatening the very existence of life on earth with genetically-modified foods. They use scary-sounding words like “Frankenfoods” and credulously share on social media stories from sources like NaturalNews.com. Their general worldview, for which they’re relentlessly fervent partisans, seems to be that anything “natural” is good and anything “artificial” is bad. They are, to use the word precisely, zealots.

Perhaps you’ve had the dubious pleasure, as I have, of defending GMOs to these people. If so, it probably went something like this:

Anti-GMO Zealot: “Frankenfoods are untestedunsafe, and should be banned!”

You: “Actually, GMOs are the most tested crops in our food supply. Over 600 peer-reviewed studies have found no evidence that GMOs are more harmful than conventional or organic crops. In fact, organic crops have killed or sickened more people than GMO foods, the Fukushima nuclear disaster, and the BP oil spill combined.”

AZ: “All of those studies were done by Monsanto and other evil corporations who just pay scientists to say whatever they want!”

You: “Well, that’s not really true, and even if it were…”

AZ: “SHUT UP, YOU CORPORATE SHILL! HOW MUCH ARE THEY PAYING YOU TO BLOG ABOUT THIS, ANYWAY?”

This is the essence of the argumentum ad Monsanto, which is really a form of ad hominem attack: because a scientist’s employer has a financial stake in the results of his studies, those results are automatically invalid, or at least heavily suspect.

There’s a certain degree of truth to this, of course. When researchers don’t disclose conflicts of interest, or when they deliberately use invalid methodology to reach a desired result, their employers’ interests can often explain their motives. But simply identifying a conflict of interest does not invalidate a scientific study, particularly when the conflict is disclosed.

After all, who is going to perform these studies, if not experts in agronomy and genetics? And where are experts in agronomy and genetics going to find work? Research universities and regulatory agencies will hire some, to be sure, but the best and brightest will be sought after by private biotech firms that can profit from their research. So of course many (not all) GMO studies are performed by employees of GMO producers; they’re in the best possible position to test them!

A man may stand to gain much by telling his wife he loves her; nevertheless, he may love her sincerely. ~Unknown

It isn’t enough to simply identify a conflict of interest; in order to show that a study is invalid, you must identify some methodological problem with the study. That isn’t hard to do when it comes to GMO studies, actually. Nearly every time some new study purports to show that GMOs are dangerous, the methods turn out to be flawed, often in a manner that had to be deliberate. Just like their close cousins in the vaccine-paranoia industry, the GMO fear-mongers tend to have personal conflicts of interest motivating their scientific malfeasance. But that makes their actions unethical, it does not make their studies invalid. Their invalid methods do that.

There is hope for us, of course, just as there’s hope for all the anti-GMO zealots out there. When you feel compelled to dismiss some scientific work simply because of who funded it, whether in the context of GMOs, vaccines, or global warming, remember that you’re committing a logical fallacy. Look instead to see whether the methods used are valid and reliable. If so, congratulations! You’ve just learned something new, regardless of who paid for it.

Oh, and Monsanto: if you’re listening, I’d really appreciate it if you did start sending me a paycheck for debunking GMO nonsense on the Internet.