Molecular Pathology v. Myriad Genetics Inc. Patent law is complex as the justices realized as they contemplated the mysterious land of biochemistry. For those of you, like myself, who chose law instead of science, you can probably imagine the mental gymnastics necessary to follow the ins and outs of science necessary to fully grasp the foundation beneath human gene patents.
The cautious justices realize what their decision may mean for the future of medical science and genetic research, specifically the dramatic effect on the pharmaceutical industry. The case stems from a lower court decision which awarded Myriad Genetics a patent allowing it to isolate human genes that specify predisposition to breast and ovarian cancer. Currently doctors and patients are required to use diagnostics developed by Myriad and have been restricted from conducting research in the particular area. As you can imagine, the bar from research by others not only monopolizes this field, but may be stifling groundbreaking and life-saving technology that others in the industry are capable of developing.
Test for Gene Linked to Breast and Ovarian Cancer is Patented
The science, as I understand it, is as follows…. There is currently a test that assists
women in determining crucial medical decisions by determining their genetic composition and whether they are more susceptible to breast and ovarian cancer. These genes are known as BRCA1 and BRCA2 in the scientific community, and currently Myriad owns the patent on the test. Women with BRCA1 and BRCA2 face an 85% risk of developing breast cancer and a 50% risk of ovarian cancer. As I mentioned above, because Myriad has a monopoly on this particular test, women have no other option when it comes to assessing their risk, and must go with the Myriad protocol for testing.
DNA - "Product of Nature"
The challengers in this case are various organizations of physicians, geneticists, patients and researchers that agree that DNA are “products of nature” and should not be patentable. Represented by Chistopher A. Hansen of the American Civil Liberties Union, the challengers believe that Myriad is undeserving of the patent in question, mainly because it did not create or invent anything here.
“The genes themselves . . . where they start and stop, what they do, what they are made of, and what happens when they go wrong are all decisions that were made by nature, not by Myriad,” Hansen said. “Now, Myriad deserves credit for having unlocked these secrets. Myriad does not deserve a patent for it.”
Though the justices understand, and perhaps agree with Hansen’s assertions, they expressed concern about consequences associated with failing to reward companies, such as Myriad, that invest loads of money into making such novel discoveries. “What does Myriad get out of this deal?” asked Justice Elena Kagan. “Why shouldn’t we worry that Myriad or companies like it will just say, ‘Well, you know, we’re not going to do this work anymore’?”
Taxpayer Funded Research - Is it the Answer?
Hansen’s simple response was to fund research via taxpayer dollars. He also indicated that research would be encouraged because of recognition associated with such discoveries. Unfortunately Justice Kennedy did not agree notoriety was enough to incentivize continued research and development with this type of science. “I just don’t think we can decide the case on the ground, ‘Oh, don’t worry about investment, it’ll come,’ ” Kennedy said.
Gregory A. Castanias, Myriad’s counsel also had a difficult time convincing the Court that the genetic material in question was somehow different from genetic material inside the average human and in fact required protection by way of a patent. “There was invention in the decision of where to begin the gene and where to end the gene” with respect to a strand of DNA, said Castanias.
In an effort to make a more understandable analogy for legal scholars that lack scientific prowess, he compared it with a baseball bat. “A baseball bat doesn’t exist until it’s isolated from a tree,” he said. “But that’s still the product of human invention, to decide where to begin the bat and where to end the bat.”
Clearly Chief Justice John G. Roberts Jr. is not a fan of baseball, because he just didn’t buy it. “You don’t look at a tree and say, ‘Well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat,’ ” he said. “You have to invent it, if you will. You don’t have to invent the particular segment of the [DNA] strand; you just have to cut it off.”
Representing the government was Solicitor General Donald B. Verrili Jr., sided with the challengers in that the gene should not be patented, however he does believe that the process in which genes are manipulated to produce a certain result is patentable.
Justice Alito, questioned whether this was an issue the court need even decide at this point and time “Why should we jump in . . . and decide the broadest possible question?” Alito asked.
You know, never in a million years would I have ever contemplated such a complex and mind boggling subject, however I happen to know a few women who have fought with breast or ovarian cancer in their time. Not all of them lived long enough to tell their tale, or be given a cure. To think that the idea of a gene patent could stifle scientific progress and impede the potential for a cure is quite bothersome to me. Let us hope the justices don’t sweep this one under the rug; I hope they consider the vast implications of a ruling in favor of human gene patents.
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