Setting the Record Straight on Gene Patents

By Gene Quinn
June 22, 2009

On Wednesday, June 17, 2009, while I was on the road in Boston teaching the PLI Patent Bar Review Course I was invited to chat with David Gleason, the host of State of the Nation, which is a radio talk show that airs in South Africa.  It seems that Mr. Gleason and his staff were devoting a significant portion of his evening show to discussing the patenting of genes, genetically modified food, designer drugs and they stumbled across IPWatchdog and invited me on to chat.  The conversation was cordial, and Gleason asked some probing questions typically written about by the popular press, but he genuinely seemed interested in the answers and in getting the best information, both pro and con, out to his listeners.  Apparently, there are some ongoing gene patent matters working their way up through the courts in South Africa, which seems to have prompted his treatment of the issue.  We spoke live on the air for about 15 minutes and he gave me a opportunity to make the case for gene patents and to disspell the rumors and misinformation that is rampant in the debate.  Who knows whether my interview will change any minds, but I did the best I can to put forth the case for why gene patents need to be allowed if we are ever going to achieve the break throughs that the patent system is supposed to foster.

One of the things that came up during our discussion was whether patents, particularly gene patents are justified given that gene patents in essence mean that a corporation owns a part of an individual, and whether they are justified given that they lock down treatments and diagnostic methods.  First, lets do away with the first premise once and for all, shall we?  Patents are simply not granted on the genetic code of a human being.  The fact that one obtains a gene patent does not mean that everyone who has genes are immediately owned by a corporation or immediately infringing for the audacity to actually have genes in their body.  It does no good to perpetuate the myth that the US Patent Office is granting patents on parts of people.  The hysteria is palpable, and was no doubt most recently instigated by the false and erroneous claims of the ACLU against Myriad Genetics.

For those who really care enough to try and figure out what is going on, the United States Supreme Court has for at least a generation allowed for the patenting of living matter.   As I discussed in The History of Gene Patents Part I, the Supreme Court, in Diamond v. Chakrabarty, stated that living matter can be patented provided that there is a modification or alteration of the living matter that evidences human intervention.  Stated another way, if there is genetic engineering instigated by human action that means that the result is not something that occurs naturally.  Once you manipulate something so that it is no longer identical to that which occurs naturally you are no longer patenting the products of nature, but a human manipulated form of nature.  That is what happens when genes are patented.  There is an isolation, modification and/or mutation of a gene.  In diagnostic methods there are these modifications, which in the interview I refer to as “teasing.”  The genes are manipulated or “teased” into a form that no longer represents nature or what is natural.  Through this process of manipulation information can be acquired and the information can then be used in some situations to identify ailments or the likelihood of ailments, which can and does significantly enhance medical care and treatment, both in a preventative and a responsive way.

[Bio-Pharma]

Second, is it proper to “lock down” diagnostic methods and treatments?  Shouldn’t these be available to everyone?  The resounding answer is absolutely not!  If I come across as a mean, nasty and/or cruel individual for stating the obvious, then you should question your own intellect, not mine or my motivations.

If we do not provide incentive for individuals and corporations to undertake the daunting tasks of commercializing inventions and discoveries then we can expect no inventions and no discoveries.  It is really that simple.  Those who choose to ignore this simple tenant of economics cannot be reasoned with, because they are illogical.  The hundreds of millions of dollars that can be required in order to discover, invent and commercialize will not be spent unless the risk-reward calculus dictates that spending such sums presents a wise business opportunity.  We are in the midst of learning in America that the government simply cannot spend all that they want to solve every problem.  To cover 33% of the 49 million or so who are without health insurance we would have to spend $1 trillion to $1.6 trillion.  That money simply doesn’t exist for us to spend, so even this woefully inadequate and horribly incomplete universal health care is not going to happen in the US. Governments cannot spend their way to utopia.  If governments stand in the way of the prosperity of those with both money and the necessary risk tolerance, we will live in a very different world where health care advances will cease to exist.

Those who demand that we stop recognizing patent rights and at the same time think that advances will take place are delusional.  Throughout the world and throughout history there is no proof that limiting intellectual property rights leads to more advances.  There is ample proof, however, that a decrease in property rights leads to lackluster economic performance.  That is why communism and socialism have never been long term successful anywhere.  Those with talent and ambition will simply not work harder to enjoy the minimum they are entitled to if they didn’t work at all.  This is not rocket science, although it is admittedly beyond the understanding of many in the “elite” class.

An issued patent enjoys a limited term, and in the pharmaceutical area that limited term of protection is typically less than 10 years.  Yes, the patent term runs 20 years from the time of filing an application, and yes pharmaceuticals are allowed up to an additional 5 year extension in term, but the reality is with all the work necessary to get a drug to market pharmaceutical companies are lucky if they enjoy 10 years of commercial sale under an unexpired patent.  So we are talking about depriving the people of a drug they cannot afford for 10 years in order to make it commercially possible for the drug company to make the drug in the first place.  We forget that without strong patent rights we would not get the drug int he first place.  Is the world better off with a drug that is cheap after 10 years, or never having the drug at all?  What if a revolutionary cure for cancer came in the form of a pill?  Would it be more morally acceptable to allow the developer to reap financial rewards for a decade and then have the drug become a cheap generic, or would it be more morally acceptable to simply never have the cure for cancer in the first place?  Those who want to do away with patents say with a straight face that we would be better off without the cure if everyone cannot have it immediately.  If you think that way, do not pass go and check yourself directly into the nearest funny farm because you are a loon and likely a danger to yourself and others!

Just to put an exclamation point onto this argument, lets not forget that those who believe patents on genes, drugs, diagnostic methods and medical treatments share an important point of view with the preeminent socialist in the world, Hugo Chavez, who over the weekend said:

A song is intellectual property, but an invention or a scientific discovery should be knowledge for the world, especially medicine. That a laboratory does not allow us to make a medicine because they have the patent, no, no, no.

So let us not sugarcoat the debate.  Those who are against these types of patents are against treatments and cures that will be freely available from the point the patent expires through all time, and share an economic philosophy with one of the most brutal dictators in the world.  They seem to want to live in a world without revolutionary technological advances, which is exactly what the Unibomber wanted, as well as so many petty dictators throughout time.  They exalt illogical positions in the name of fairness, and while they make a “greater good” argument refuse to acknowledge that the undeniable greater good is to  let all generations after ours reap the rewards of scientific advances and inventions conceived today.  Exactly how fair is it to have the ability to cure disease and stand in the way out of hatred of capitalism?

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 11 Comments comments.

  1. breadcrumbs June 24, 2009 6:58 pm

    Gene,

    It seems that three comments on this thread tend to appear and disappear randomly. Are you aware of this?

  2. Gene Quinn June 24, 2009 9:12 pm

    Breadcrumbs-

    I am unfortunately well aware of the disappearing comments. In an effort to focus on business I decided to hire a webhosting company nearby that could run my server and tend to the technical matters. This was a terrible decision and the nightmare began about 2 weeks ago. For reasons that are beyond my understanding my site never ran properly. There were database errors, site inaccessible and on Friday for a time all of the links when clicked took users to “page not found.” The errors would come and go randomly, I would complain, they would allegedly fix it, then it or something new would go wrong the next day. It got to a point where every day I was spending hours and hours trying to get answers, which were contradictory and provided little information other than “that shouldn’t happen again.” It happened repeatedly, I lost entire posts and yesterday when I settled into work I noticed that the site was again having troubles, not displaying properly and I decided I had to get back to a server I could manage and cut them loose. So yesterday the site was up, down and sideways much of the day. Now the site for some is pointing to my new server and for others to the old server, which hopefully will be rectified within a day or two. Right now I have to access things via wireless internet card because my ISP still delivers cache from the old server. It has been a nightmare!

    I hope this will all stop soon and I can get back to writing, and working on business. I have had e-mail interruptions, business has suffered, and for the privilege of all this needless extra work I had to pay $515 I won’t get back.

    Sorry for venting. I plan on posting on this in the coming days once I feel somewhat at ease that the “mistake server” is out of the loop and I am on a stable platform.

    -Gene

  3. Al June 25, 2009 5:56 pm

    My post got deleted as well. I just wanted to say that this was a great interview and we really need a discussion like this to air on NPR for listeners in the US.

  4. Gene Quinn June 25, 2009 7:15 pm

    Thanks Al. I am trying to recreate the comments.

    -Gene

  5. Gene Quinn June 25, 2009 7:16 pm

    Posted by Gary on Wed, Jun 24, 2009 at 10:37 PM

    “As a scientist, I’m unable to sequence BRCA1/2, whether it’s from a patient carrying the wild-type (normal) or mutant form. Myriad simply prevents me from doing that, because as soon as I sequence those genes, I will be infringing on their patent. Myriad did NOT create these naturally occuring substances, did NOT “tease” them in any way like Gene suggests in his previous article about gene patents, did NOT discover the method of isolation of these genes from tissues, and certainly did NOT discover the methodology they currently use in their diagnostic lab to identify mutations.

    So I’m baffled as to how you guys can argue in favor of this patent.”

  6. Gary June 25, 2009 7:29 pm

    Could someone please point out the claim(s) in the BRCA1/2 patent that shows “teasing” of the genes?

  7. Adam June 26, 2009 11:19 am

    In my original comment I brought up the Canadian Supreme Court’s ruling on Monsanto Canada Inc. v. Schmeiser. In it, they said that gene patents on GM crops also apply to the plants themselves, so that Mr. Schmeiser cannot plant seeds saved from his own fields without infringing on Monsanto’s patents.

    While we don’t have a similar ruling in the US (to my knowledge), it may be prudent to be cautious of any movement in that direction by US courts. Such movement could potentially lead to a slippery slope where even higher forms of life can be controlled by patents.

  8. Gene Quinn June 26, 2009 11:39 am

    Adam-

    I think reference to the Schmeiser situation is extremely misleading. The courts in Canada repeatedly ruled that he infringed and that the knew or should have known that he was infringing.

    The facts actually showed that Schmeiser is not the angel that many portray him to be. In fact, he intentionally sprayed a portion of his fields with Round Up and 60% of his crops did not die, which indicated to him that the Monsanto patented seeds were being used. He collected seeds from those surviving plants and then intentionally proceeded to infringe the patents. The Canadian courts also repeatedly rejected his theories with respect to how the Monsanto patented seeds allegedly “naturally” found way into his farm in the first place. In other words, the courts repeatedly found that Schmeiser was not honest and acted intentionally.

    So you are right, we definitely need to be on the look out for Schmeiser-like activity and make sure that we prevent such illegal taking of patented innovations.

    See:

    http://www.monsanto.com/monsanto_today/for_the_record/percy_schmeiser.asp

    http://techyum.com/2007/12/monsanto_v_scheiser_1.html

    Canadian Supreme Court Decision (you should really read this, it explains exactly what the Court found Schmeiser did, and how he was not believed and his actions were intentional.

  9. Adam June 26, 2009 2:37 pm

    Gene, I think it’s pretty clear that Schmeiser knew what he was doing: planting Roundup-Ready Conola. My point was that even though he did not enter into a licensing agreement with Monsanto, they were ruled to have the right to control the use of his own plants, which are living, high-level life forms. To quote from the decision:

    “It is no bar to a finding of infringement that the patented object or process is a part of or composes a broader unpatented structure or process, provided the patented invention is significant or important to the defendant’s activities that involve the unpatented structure.”

    This indicates that, at least under Canadian law, it is irrelevant whether or not you can patent a whole organism. Just patent a tiny piece of it and you have the same protection. However, I will admit to finding this point very confusing, since the decision swears up and down that you can’t patent the plant, as if this is a significant point.

    If this is indeed the precipice of a slippery slope, and in the future some US court may extend these same rights out to animals or even humans, that means that patent owners can use IP rights to control the reproduction of animals or humans. I’m not saying we are currently in danger of having patents on humans. We’re not anywhere close to it. All I’m saying is that we may be wise to be very cautious about movements in that direction.

  10. breadcrumbs June 27, 2009 10:38 am

    Gene,

    I liked the (fleeting) feature of showing the number of visits to each thread next to the number of comments. Can this be restored?

  11. Gene Quinn June 27, 2009 1:18 pm

    Breadcrumbs-

    I just added it again to the homepage and the category pages. Still trying to figure out the right or best way to display it on the article pages themselves.

    I hope all is well.

    -Gene