Thursday, April 1, 2010

In the current landmark case of Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., U.S. District Judge Robert W. Sweet has ruled that certain natural genes are unpatentable because they involve a “law of nature.” This decision finally begins to correct the patent office’s misapplication of patent law to some naturally occurring substances such as human DNA. Human DNA is composed of about 25,000 genes, about a fifth of which have been patented as chemical compositions. If upheld on appeal, this decision could be a turning point for reining in the disturbing practice of patenting genes that were never “made by man” - the Supreme Court’s fundamental standard for patentable subject matter.

There are many sorts of gene patents, including some perfectly acceptable ones regarding innovative processes or modified genes. But contested patents held by co-defendant Myriad Genetics over the BRCA1 and BRCA2 genes went much further: They granted exclusive rights in naturally occurring mutations to naturally occurring sequences. The company was instrumental in identifying these mutations - known to be associated with higher rates of breast and ovarian cancer - but should these findings alone suffice to receive effective control over any medical use of such facts? By looking to some principles of our patent system, we can answer this question simply and justly.

Laws of nature have long been held to be unpatentable. Thus, while one might patent an elevator - provided it is new, useful and non-obvious - Newton could not have patented the principle of gravitation. Similarly, natural products and substances also have been held unpatentable - in stark contrast to tools or methods for observing, obtaining or using those products or substances. Below is an example of a disputed Myriad patent claim:

“An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”

Defenders of Myriad’s and similar patents contend they merely extend existing precedent allowing patents on “isolated” or synthetic versions of otherwise natural substances. It’s true that some courts historically have allowed patents on newly isolated items (e.g. adrenaline, insulin, vitamin B12), crediting the “new utility” of their isolated forms. But this rationale is misguided: While human ingenuity has indeed led to the useful finding and isolating of many natural things, such ingenuity accounts only for the means of isolation (or use) and not the underlying characteristics.

Moreover, natural genes are isolated in the first instance by nature via cellular metabolism. Protein synthesis is accomplished when various proteins and RNAs read genes within DNA, omit select excluded portions, and assemble amino-acid sequences encoded by the remaining nucleotides. So, nature made the feature and defined its borders, which humans then find and reconstitute accordingly. In fact, to produce an isolated gene in vitro, cellular mRNA is commonly used for a template. Whatever trivial differences exist between an isolated gene and its corresponding mRNA or pre-isolated DNA form, the former is at best an obvious variation upon one of the latter. As laudable as many discoveries are, observational (vs. inventive) discoveries are simply not the type of scientific progress that patents exist to reward.

Consider that Jons Jakob Berzelius was first to discover that water is formed by two hydrogen atoms and one oxygen atom - plus first to isolate certain elements. Should he have received a monopoly over any production of, or searches for, pure water or isolated silicon based on those achievements? Clearly not, and this highlights the error of allowing patents on natural occurrences. Myriad’s role in identifying the structure of a natural mutation (relevant to early disease detection) should not result in exclusive rights to the gene itself (and thus any testing for it). Such patents go too far, covering observable phenomena not invented “by man” - thus belonging to mankind.

David Koepsell is an author and philosopher, teaching at Delft University. Kenneth Alfano is an engineer, teaching at the University of Michigan. Both are also lawyers.

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