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PostHeaderIcon Who Owns Your Genes?

UPDATE: In a split decision, the Federal Circuit on July 29, 2011 reversed. The majority found that while certain claims of Myriad's patent were invalid for claimin a process that was not sufficiently "transformative", the claims to an individual person's DNA were valid because to test them for the subject precancerous gene, the DNA was "altered" by severing chemical bonds to extract it for testing.  In dissent, Judge Bryson likens the process to "snapping a leaf from a tree. Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention."

Writing for the majority, Judge Lourie is persuaded by the patentee's argument that it has transformed the DNA in a patentable way, even though it still carries the genetic information of its former host.  Judge Moore, concurring, seems more impressed by the fact that the Patent Office has already issued more than 40,000 such patents, and is therefore loathe to upset the status quo.

What's next?  Probably en banc review by the entire 17-judge Federal Circuit, and then on to the Supreme Court. To view the entire opinion, go to: www.cafc.uscourts.gov/opinions-orders/0/all/myriad.

Here's the original article as published May 4, 2010:

Unless you are a woman residing in the Southern District of New York, where Judge Robert Sweet recently issued a momentous 152-page opinion which may forever change the course of U.S. Patent law, you still have to go to a Utah company, Myriad Genetics, to find out whether you carry the breast cancer predicting genes BRCA1 and BRCA2. (Links to the Association For Molecular Pathology v. USPTO complaint and opinion are in the menu to the left.)

Myriad charges $3,000 per test, doesn't take Medicare, and by virtue of its heavily reinforced patent position has no U.S. Competitors. (Canada refuses to recognize Myriad's patents. A test there costs only $1,000.)

Is the decoding of the human genome a “discovery”? Should the patent laws give the authors the exclusive right – for a limited time – to the results of their work?

The Constitution. The U.S. Constitution specifically recognizes intellectual property rights in inventions and writings. Congress is given the authority in Article I, Section 8 “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”

The Patent Act. In 35 U.S.C. Sec.101, expresses the Framer's intent in this way:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this Title.”

The Opinion. So is a human gene a “new and useful... composition of matter”? Or an “improvement thereof”? Judge Sweet doesn't think so. While his opinion steps away from holding that Myriad's patents fall short of being the “discoveries” contemplated in the Constitution, the result is the same. Whether the BRCA1 and BRCA 2 genes were “discovered” or not, they were certainly not created, or even transformed, by Myriad or its researchers. The ruling is almost certain to be appealed, and if upheld, the USPTO will no longer be able to grant patents on substances which are naturally occurring in nature, the most obvious example being human genes. In the last 20 years, private companies and researchers have been issued patents on up to 20% of the genes in the human body – more than 4,300 in all. These patents are now almost certainly doomed to invalidity, as being directed to non-statutory subject matter.

So what, exactly, did Myriad think it was patenting in the seven patents at issue in this case? Their claims fall into two groups: composition of matter (claims to the genes themselves), and the mental processes of determining whether the genes, if detected, may be cancer-causing (method claims).

Typical of the composition of matter patents is US 5,837,492 issued 11/17/1998. It claims an exclusive right to “ An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer” (Claim 6) The existence of this gene, and its ominous role as a predictor of breast cancer in its owner, has probably been present over hundreds of thousands of years of human evolution. Myriad did nothing to it, or with it, but only identified it.

Typical of the method patents is US 5,709,999 issued 1/20/1998, which asserts an exclusive right in “A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1”. (Claim 1). Judge Sweet notes that in this claim, like each of the other method claims in issue, the the critical – and presumably inventive – element of the process is only described in general terms, such as “analyzing” or “comparing”, with no quantitative step disclosed or suggested. He concludes “As a result of the breadth of these composition claims, they reach isolated BRCA1/2 DNA obtained from any human being.” (Opinion pg. 82)

Judge Sweet takes care to distinguish Supreme Court precedent allowing the patenting of a new, genetically engineered bacterium (Diamond v. Chakrabarty, 447 U.S. 403) from other precedent which in which the concept of patenting a mixture of several naturally-occurring species of bacteria was rejected (Funk Bros. 333 U.S. 128-131) as being “the handiwork of nature”). But this case presented a different issue. “The entire premise behind Myriad's genetic testing is that the claimed isolated DNA retains, in all relevant respects, the identical nucleotide sequence found in native DNA.” (Opinion pg. 132) “Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. Sec. 101.” (Opinion pg. 135) “This claimed 'process' is, in fact, the scientific method itself, and claim 6 [of US 5,747,282] seeks to patent a basic scientific principle: that a slower rate of cell growth in the presence of a compound indicates that the compound may be cancer therapeutic.” (Opinion pg. 148)

Drug Patents y v. Public Policy. Viewed in a global context, Judge Sweet's decision is hardly shocking. For public policy reasons, most modern countries – other than the U.S. - barred the patenting if drugs altogether.

For example, drug patents were not allowed at all in India until 2006, when as a World Trade Organization member, India had to comply with WTO's trade rules, one of which (the Agreement on Trade-related Aspects of Intellectual Property, or TRIPS) which obliges WTO countries to follow the U.S. Lead and grant patents on technological products, including pharmaceuticals. To comply, India changed its patent law in 2005 and started to grant a relative few patents on medicines for the first time.

In France, there was no patent protection for drugs (as opposed to the processes for manufacturing them) until 1966, finally allowing limited patents for pharmaceutical products. The ban on patenting drugs themselves was not completely lifted until 1978.

In Italy, pharmaceutical patents were prohibited until 1978, when its Supreme Court ruled in favor of eighteen pharmaceutical companies, all foreign, seeking to enforce foreign patents on medical products.

Similarly, in Spain, the law was changed in 1986 to allow patents on drug products as a consequence of the country’s entrance in the EEC. The law began to be applied only in 1992. Before that date, regulations dating back to 1931 explicitly prohibited the patenting of any substance and, particularly, of any pharmaceutical substance.

The Take-Away. This ruling, if upheld on appeal, will be nothing short of revolutionary. Researchers will again be free to take advantage of the immense advances of the past twenty years in understanding the human genome by moving past the thicket of patents that now stands in their way.

 

Last Updated (Sunday, 31 July 2011 09:25)