Imagine you are sitting in your doctor’s office following an extensive battery of medical tests.  You fear the worst.  And, your fears are confirmed when your doctor breaks the news that you have cancer.  But, he cautions you not to be despondent.  There is hope: genetic testing to determine if you carry mutations that increase your risk of other related cancers which will take the guess work out of designing an appropriate treatment plan.

Now imagine that you are back in your doctor’s office several days later.  The blood tests that your doctor had submitted to a biotechnology company that patented a sequencing test for the cancer-related mutation whose presence you are attempting to discover were not processed.  The biotech company did not accept your insurance and you, as a person of limited means, could not come up with the $4,000 to have the test performed.  A cheaper test does not exist because the biotech company holds an exclusive patent to the genes as well as the process for isolating the relevant genes.  With the test, you and your doctors would have the knowledge to better assess your best treatment options.  Without it, you and your doctors are guessing.

That is the situation that informs the background of the Molecular Pathology v. U.S. Patent and Trademark Office case, 09 CIV 4515, heard in a Manhattan federal court earlier this month.  The case is relatively novel.  It asks whether genes, isolated from a human DNA sequence, are sufficiently new and useful to be patented under federal patent law.

Although approximately 20% of all human genes are patented, the gene mutations at issue in this case are the BCRA-1 and BRCA-2 genes, both of which are closely associated with breast and ovarian cancers.  The plaintiffs include a group of cancer patients who were unable to have the test performed, and numerous scientific and medical groups, including the named plaintiff, the Association for Molecular Pathology.

The defendant biotechnology company, Myriad Genetics, has been characterized by Chris Holman, a professor at the University of Missouri-Kansas City School of Law whose interest lies in biotechnology and intellectual property, as:

[a] leader in the commercialization of genetics diagnostic testing, probably best known for its BRCA tests used to assess a woman’s genetic predisposition to breast cancer. Since the late 1990s, the company has been the subject of widespread criticism, both in the U.S. and abroad, over what many have perceived to be overly aggressive patent enforcement policies, particularly with regard to its BRCA patents.

Under US federal patent law, inventors can exclude others from making, using, or selling the patented invention for 20 years.  Through its seven patents, Myriad has created a monopoly, which controls all testing related to BRCA1 and BRCA2 as well as the genes themselves.  Furthermore, a gene patent-holder can control any use of its patented gene during the 20-year patent period.  So, while Myriad may allow researchers to pay for the privilege of working with its patented genes to further research objectives, it is still criticized for its patent policies.

Professor Holman explains,

In fact, much of the criticism directed at so-called “gene patents” traces back to the controversy surrounding Myriad. To this day, allegations that Myriad’s patent policies have somehow unduly limited access to BRCA testing services, or even prevented competing laboratories from providing superior BRCA testing services, are cited in support of proposals to ban the patenting of genes and DNA.

Kevin Noonan, a lawyer practicing pharmaceutical patent law with McDonnell Boehnen Hulbert & Berghoff LLP and who holds a doctorate in molecular biology, writes “Genes are a product of nature…but the patents claiming genes do not claim products of nature.”  Noonan argues that instead the BRCA1 and BRCA2 genes are isolated or purified products of nature, in the form of cDNA or a recombinant molecule or vector, which are patentable under a precedent dating back to a 1912 adrenaline case,  Parke-Davis & Co. v. HK Mulford. Noonan also argues that human genes are not per se unpatentable because:

To be patent-eligible, an invention must be a machine, manufacture, process, or composition of matter, or an improvement thereof, and (per Supreme Court precedent) cannot be a mathematical formula, an abstract idea, or a product of nature.  To be patentable, on the other hand, an invention must be new, useful, and non-obvious.

Noonan’s position, and that of Myriad, is that the scientific innovation involved in first finding the BRCA1 and BRCA2 mutations and then isolating the gene makes its work patent-eligible and patentable.

Jane Bosveld, wrote in last month’s Discover Magazine, “many scientists believe Myriad’s control has slowed or blocked research” citing as an example the prohibition against developing a “more accurate screening test because doing so would infringe on Myriad’s patent.”  A geneticist at the Hospital of University of Pennsylvania criticized  the biotech company’s patent, stating “a number of researchers had been looking for the genes related to breast cancer and knew where the genes were likely to be.  Essentially the work was done for Myriad already.  Everyone knew where the gene was.”

Is this criticism warranted?

I am not arguing with Noonan’s or Myriad’s position as a matter of fact or law.  In fact, as the statute is written, Myriad’s actions were perfectly within the scope of law.  I am not even going to touch the criticism of biomedical professionals who argue that Myriad took advantage of the Human Genome Project.

Rather my issue with Myriad’s conduct is from a public policy standpoint.  As someone who would like to see companies balance their profit margins with a corporate moral responsibility code, in my humble opinion, Myriad Genetics falls short of the balance that can be achieved.  It’s monopoly on the screening process and the gene itself that essentially limits medical access to those who can afford the expensive screening test or who have acceptable insurance coverage.

I understand the need for companies to recoup its research and development costs and fully support the principles of capitalism.  However, I believe that companies have a certain responsibility to be a good moral actor.  Myriad’s actions prove that it is not a good actor.  For example, in 2002, French scientists who alleged that Myriad’s test “only assesse[d] 10-20% of potential BRCA1 mutations, identified a mutation that Myriad missed.  Although the French test had a greater breadth and was less expensive than the approximately $2,700 that Myriad charged French patients,” Myriad issued cease and desist letters to the French researchers.  Myriad has been just as aggressive in stymieing researchers who seek to develop more comprehensive screening tests during the Myriad BRCA1 and BRCA2 patent period.

But Myriad Genetics is not alone.  Athena Neurosciences, Inc. also used its patent monopoly on the APOE gene to prosecute physicians and laboratories that attempted to determine if patients “carry this genetic predisposition to Alzheimer disease” without relying on Athena’s screening products or devices.

Proponents of gene patenting will surely call me out on my views, but I am encouraged by the opposition voiced by such luminaries as the National Institutes of Health director Francis Collins and legal scholar Lori B. Andrews.  Both oppose broad human gene patents.  Mr. Collins recently wrote:

The information contained in our shared instruction book is so fundamental, and requires so much further research to understand its utility, that patenting it at the earliest stage is like putting up a whole lot of unnecessary toll booths on the road to discovery.

For further discussion on the patentability of human genes, please go here, here, and here.

As a college student, I worked in the laboratory of the director of the breast cancer research group at the University of Illinois and University of Illinois College of Medicine at Urbana-Champaign.  I was not involved in biomedical research, I only maintained the lab’s research library and performed some minor administrative tasks, but I came away from my time in Dr. K’s laboratory with a profound respect for the collaborative spirit and back-breaking work that is biomedical research.  The rewards are few and far between.  It may take months, years, and sometimes decades before a scientist makes a breakthrough.  But, isn’t it the purpose of the scientific community to spur on further innovation and discovery?  Doesn’t withholding information under a patent claim impede scientific research?

So, while I applaud Myriad Genetic’s innovation in identifying these genes, I wonder if an individual will be able to forgive the company and its corporate leadership the decisions that they made and continue to make by denying poorer individuals the chance to benefit from scientific innovations that are available to wealthy. After all, “there are no alternatives to the patented human genes in genetic diagnosis and gene therapy – and these inventions might mean the difference between life and death to the [patient].”  Truer words were never spoken, Lori Andrews.

Posted by Krystyna on February 25, 2010 at 12:42 pm.