The District Court Judge of the Southern District of New York, Judge Robert Sweet will go down in History. Amidst much speculation and debate, the Judge, on March 29th 2010, ruled in the case of Association for

Judge Robert Sweet

Judge Robert Sweet

Molecular Pathology v. U.S. Patent and Trademark Office, that the patents For BRCA1 and BRCA2 held by the company Myriad Genetics, were invalid. The decision was a highly anticipated one since this particular lawsuit has been hailed by many as being a direct attack on the company and the USPTO (The United States Patent and Trademarks Office). The issue of gene patenting has always been a controversial one and there have been heated debates for and against it. However, in recent times, we have seen with increasing unease, the extent to which essential health care testing, diagnostics and even treatments have slowly but steadily passed the truly needy patients by because of prohibitively high costs and monopolistic trade practices by many such companies in the name of millions of dollars sunk into research for the same.

The current judgement is a 156 page decision and invalidates about seven of the patents held by the company Myriad Genetics related to the BRCA1 and 2 genes that have been implicated in breast and ovarian cancers. If this decision is upheld by the Higher courts, it has the power to completely challenge many of the existing gene patents and change the face of Intellectual property law as we know it forever.

So what really is a gene patent. Wikipedia defines it thus: A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims. Thus in essence, a gene existing within an organism is not patentable and neither is it of any use to us clinically if it remains as such. The moment it has been isolated, purified, it can be put to commercial use, as in for diagnosing clinical conditions such as cancers or treating them. This was presumably the premise underlying the grants of such patents in the first place. However, the premise seems to be rather ridiculous to me. Most of the genes under patent protection today (about 20 % of the genome is patent-protected) are not inventions but discoveries. If the mere act of isolating them from the body turns them into something ”novel” , then by that token a large number of chemical entities can be considered novel by simply isolating them from their parent source. This will lead to patents on a large number of ridiculous ‘inventions’. Writer Michael Crichton makes an emphatic point in an article in the New York Times. He says and I quote,” Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn’t somebody make a cheaper test? Sure, but the patent holder blocks any competitor’s test. He owns the gene. Nobody else can test for it. In fact, you can’t even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it’s now private property.”

I am sure most of my readers would agree with me that this situation is bizarre. It begs the question how could the USPTO be so irresponsible as to grant such patents in the first place? In the current ruling, Myriad Genetics, that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit. However, Judge Sweet made the point that such patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

In an important observation, the court ruled as follows, “The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.”

While browsing the net I came across an interesting perspective on the judgement, I quote from the author’s post, “This lawsuit against Myriad signifies a change in that it finally places the patient and the administration of genetic testing at the centre of the stage.  Although the Court’s holding focuses on patent subject matter the court dedicates a significant part of the opinion to access to BRCA1/2 genetic testing. Myriad charges about $3,000 for testing an exorbitant amount compared to other genetic tests. Furthermore, Myriad does not allow other laboratories to conduct the testing – all samples have to be sent to its headquarters in Salt Lake City. The opinion tells the stories of women who were unable to test to find out whether they carry the BRCA1/2 genes because Myriad would not accept their insurance. It recounts the ordeals of women who could not get definitive answers through Myriad’s testing and were precluded from seeking testing elsewhere. It underscores that women were unable to get a second opinion of the test results because tests are conducted only by Myriad. It also discusses the efforts of doctors and laboratories that were willing and able to offer BRCA1/2 testing but were precluded by Myriad from conducting the testing.”

Many are not comfortable with the idea of patenting genes. Michael Crichton in his article talks about the need to have open access to information. He cites the poignant case of a disease known as Canavan Disease. This is a debilitating disease that is inherited and in which infants are unable to crawl or walk, suffer seizures and rarely survive beyond their adolescence. He goes on to document the ironic and heart-breaking history of the research that led to the development of the diagnostic test for this disease. Because of the lack of such a test in the first place, families who had borne children with the Canavan disease came together and donated tissue samples for study. They engaged a researcher to identify the gene and donated their time and money for the same. Eventually the efforts met with success. The gene was identified in 1993. The families managed to get the commitment of a New York Hospital that it would offer a diagnostic test for the defective gene to anyone who needed it for free. In a twist of fate however, the employer of the hospital, Miami Children’s Hospital Research Institute patented the gene and refused to allow any health care worker to use the test without paying a royalty. The families who had contributed did not believe in patenting and so did not put their names on the patent and consequently had no claims whatsoever on the fate of the research.

If companies were denied access to essential material for research like for example tissue and blood samples or even clinical data or the questionnaires filled out by the patients and/or their families, would they be able to pursue their research at all? Let alone come to a point where their “inventions” become money spinning prospects for the companies? If recognising their efforts and granting them patent protection means that they are going to use this as a license to charge whatever they please for the tests, prevent anyone else from coming up with a cheaper alternative and effectively making efficient healthcare the privilege of the few, I think this goes against the spirit of the law.

This is exactly the position taken by Judge Sweet in the above landmark decision. He has placed emphasis on the fact that accessibility of genetic testing is a key concern and that granting patent protection for superfluous claims is a dangerous trend. Whilst not passing any ruling on the larger constitutional issue of why the USPTO granted such patents in the first place, he has underscored a larger more important issue; One of the plight of the patients. It is more important now that we learn to strike a balance between protecting an inventor and the extent to which this protection should be granted in the face of abuse of exclusive rights and grants.

In 2007, the European Patent Office (EPO) rejected an appeal by Myriad Genetics and the University of Utah, and upheld an earlier decision  to revoke some claims of patent EP705902 relating to the BRCA1 gene and its applications. There was widespread objection to the extent of this claim among European researchers, since it granted an effective monopoly to Myriad which they believed unjustified; six bodies filed objections, leading to a decision by the EPO in 2005 to substantially amend the patent, retaining only the claims relating to a specific nucleic acid probe and vectors containing gene sequences. The EPO has now rejected an appeal by Myriad and the University of Utah, and amended the patent, meaning that European laboratories retain the right to perform diagnostic tests for mutations in the BRCA1 gene sequence, which are associated with increased susceptibility to breast and ovarian cancer.

Thus, in countries where gene patenting is not recognised, testing facilities can be made cheaper and probably even more efficient than the original one. The point that we need to mull over here is this: can there be another method to make this system work for both the researchers and the end-users? For example, can we reduce the term of patent protection in such cases or put a ceiling on how much a company with patent protection can charge for a particular test/ treatment so that it covers its costs but does not profiteer and do so at the expense of patients for whom the research was meant to be in the first place. Also, if a company is found to be recklessly profiteering, can we not have punitive measures for the same? Or make exceptions in costs for patients who might not be able to spend so much for a single diagnostic test? If a patient desires to have another lab carry out the test in order to verify/ confirm/ have a second opinion, instead of the patent owning company blocking it out, can it not work out a cost sharing with other laboratories so that the system becomes more transparent?

This is one of those questions that begs deeper debate. We cannot afford to get defensive or offensive and merely argue. This problem needs urgent and fair solutions. One the one hand, the fate of Biotechnology companies hangs in the balance, as experts say newer companies will find it difficult to raise venture capitalist funding if they are not sure they will get strong patent protection. On the other, monopolistic patent protection granted on frivolous grounds is like playing with the lives of patients. I laud Judge Sweet for his gumption in giving the kind of decision that he has. It is indirectly a comment on the haphazard and mindless policy of the USPTO (contrast this with the behaviour of the EPO on the same issue).

I will write another article where I will attempt to analyse a few aspects of the judgment. But as for now, I will content myself with just saying this…… We are at the brink of a major change. How we use this opportunity will decide our fate in more ways than one!





4. ( A general Interview with Judge Robert Sweet)