PATENTING HUMAN GENES: The Myriad Case

The U.S. Supreme Court has made a number of important decisions in the last few months, two of which are relevant to topics on this blog:  (1) Bowman v. Monsanto; and (2) Association for Molecular Pathology v. Myriad Genetics.

I wrote about the Bowman v. Monsanto case last February, and I won’t repeat myself here—except to say that the Supreme Court ruled that farmers can’t save patented seeds and reproduce them by using them to grow a new generation of plants.  In my opinion, that case was almost a no-brainer, in that prohibiting others from copying your patented inventions or copyrighted works is central to intellectual property law, and the Court HAD to rule in favor of Monsanto.

The second case is more far reaching in its consequences.

The Supreme Court made two basic rulings in Myriad:  you can’t patent human DNA sequences as they occur in humans (“native DNA”), but you CAN patent human DNA that has been changed artificially.

The Myriad case was directed to two genes involved in causing breast cancer:  BRCA1 and BRCA2.  There were three patents in question:  U. S. Patent 5,747,282, U.S. Patent 5,693,473 and U. S. Patent 5,837,492.  It is historically interesting to note that these patents were filed way back in the early 1990’s—at a time when the human genome  had not yet been sequenced and published, which didn’t happen until the early 2000’s.  So the Myriad patents were revolutionary at the time—but by today’s standards, not so much.  In fact, the Myriad genes could not be patented today.  In order to be patentable, an invention has to be “novel”, and the publication of the human genome made the native DNA sequences of all human genes “not novel.”

Since Myriad’s patent applications on the BRCA genes were filed before publication of the human genome, Myriad couldn’t be denied a patent on those grounds.  But the Supreme Court’s ruling was not based on “novelty,” but rather on the assertion that a native DNA sequence is a “product of nature.”  And U.S. patent law says that that a product of nature is not eligible for patenting, the logic being that it is not a human invention—nature made it. 

The problem is that actually discovering at least SOME products of nature requires a heck of a lot of inventiveness.  It is not entirely clear to me where a “product of nature” that has been identified and laboriously extracted from nature differs from an “article of manufacture”, which is one of the categories of things that CAN be patented.  And, in fact, many naturally-occurring products have been patented in the past—aspirin, insulin, vitamin B12, and adrenalin, to name just a few.  Actually isolating these compounds required inventive activity and a recognition that they would be useful.  And back 1990’s when Myriad’s patents were issued, the U.S. Patent and Trademark Office obviously thought that isolated DNA sequences were patentable subject matter.  In fact, their identification and isolation required a high degree of inventiveness.

In their native state, the BRCA1 and BRCA2 genes are wrapped up with various proteins—scaffolding proteins such as histones that help maintain a 3-dimensonal structure.  Additionally, each gene has methyl groups spread around particular nucleotides, particularly the cytosines, to help regulate gene expression.  But the Myriad BRCA patents in question only cover the gene sequences (each consisting of about 80,000 base pairs), but NOT the methyl groups or the histones.

So the patented BRCA1 and BRCA2 genes don’t look anything like the BRCA1 and BRCA2 genes found on a human chromosome.  It’s kind of like the difference between a baseball bat and the limb of the ash tree from which it was made.  Certainly the baseball bat existed within the tree limb—but getting it out took skill and inventiveness, wouldn’t you agree?  (Unfortunately I can’t take credit for that great metaphor.  Wish I had thought of it though.) 

The bottom line is that the Supreme Court says “native gene sequences” are not patentable, and that’s that.  Also, a narrow reading of the Court’s opinion indicates that its decision is restricted to human gene sequences.

But even so, and this is an important point, it is possible that the Myriad decision could put the entire field of “natural product” patents in jeopardy.  Take, for example, natural products that have medicinal uses.  The same logic used by the Supreme Court to invalidate Myriad’s  patents also could be used to preclude patenting of a plant-derived cure for AIDS, for example.  I just don’t see the difference.  And if pharmaceutical companies can’t get patent protection on plant-based drugs, they might just quit doing the costly research that leads to the discovery of those drugs in the first place.

Want some cool examples of natural products that have been patented, and may not be in the future?  Here are a few:

(1) Sirolimus, a chemical isolated from a bacteria found on Easter Island (how cool is that?), is both an antifungal and antibiotic, as well as an immunosuppressant that is used to prevent organ rejection in kidney transplants.  Sold by the trade name Rapamune.  U.S. Patent 3,929,992.

(2) Aplidine was first isolated from sea squirts (even cooler!) is a novel antitumor agent that has received orphan drug status for the treatment of multiple myeloma, a blood cell cancer.  U.S. Patent 5,834,586.

(3)  Exenatide is a chemical compound first found in the saliva of Gila monsters (way cool!) that is used for the treatment of diabetes.  U.S. Patent 5,424,286.

I could go on and on with such examples, but you get the idea.

As mentioned at the beginning of this blog, the Supreme Court ruled in Myriad that human DNA could be patented if it had been artificially changed from its native state.  Well, this almost had to be the case.  If something is artificially changed, it becomes an article of manufacture, and articles of manufacture ARE patentable.  No controversy there.

So what are the consequences of the Myriad decision?

Thousands of gene-related patents have been issued in the last 30 years, and even more “natural product” patents have been issued in the last 100 years.  Since the biotechnology industry is very dependent on products of nature, some areas of biotechnology, such as stem cell research, for example, could be in jeopardy.  After all, deriving a stem cell line from a skin cell or umbilical blood is about as “natural” as you can get.  Since patent protection can be a big part of what makes new ventures profitable, certainly investors will be, or should be, more cautious than they have been in the past about putting money into these types of products. 

Another potential unintended consequence of the Court’s decision is that inventors may decide to keep their discoveries secret rather than publish them.  The patent system is really a trade-off in which the government says, “In exchange for disclosing your invention to the public in a patent application, we will give you the right (a patent) to keep others from making, using, or selling that invention for a limited period of time.”  But if the government doesn’t keep its side of the bargain by issuing a patent, can inventors really afford to let everybody else in on their secrets?

Then again, the stock price of Myriad is trading at nearly all-time highs.  The market seems to have taken the Supreme Court’s decision in stride, and we may very well find that it was mainly a political decision, and thus without significant consequence.

But I doubt it.