In a lawsuit challenging patents covering diagnostic tests for mutations in genes, the University of Utah and Myriad Genetics lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the human genes known as Breast Cancer Susceptibility Genes 1 and 2, or “BRCA1” and “BRCA2.”  The 152-page decision (Myriad Decision) addresses questions about whether human genes should be subject to patent protection.

In an amicus brief filed by the Biotechnology Industry Organization (BIO) and The Association of University Technology Managers (AUTM) set out this familiar position in an amicus brief of their own, stating:

Isolated DNA molecules are unquestionably “composition[s] of matter,” 35 U.S.C. §101; the district court’s ruling that they are nonetheless categorically unpatentable rested on three fundamental errors.

First, the court incorrectly treated isolated DNA molecules as merely “purified” forms of naturally-occurring substances; in fact, they are new, man-made chemical compositions that do not occur in nature.

Second, even if isolated DNA molecules could be treated as purified versions of naturally-occurring DNA, the process of isolation requires such a level of human intervention and so alters their character and use as to make them patentable under settled law.

Third, the district court was led astray by the comparison of DNA sequences to “information”—a common metaphor that is useful in conveying complex science to laypersons, but that does not change the fact that DNA remains a chemical compound, not an alphabet or a language.

The utility of isolated DNA molecules derives from their chemical structure, which is, and can only be, developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter.

Although isolated DNA molecules clearly are “composition[s] of matter,” the district court ruled them unpatentable because it believed them to be the “purification of a product of nature” and patentable only if they possessed “markedly different characteristics” from naturally-occurring DNA.

The district court’s analysis was doubly flawed. First, isolated DNA molecules are not the “purification” of naturally-occurring DNA. Rather, they are entirely different man-made molecules that do not appear in nature. Second, even if isolated DNA molecules could be considered “purified” forms of native DNA, the isolation process transforms the DNA into a new and different article with distinctive form, properties, and uses, rendering the isolated molecules patentable under longstanding precedent.

Native DNA simply cannot be used in these therapeutic applications. Rather, it is only when a new, isolated DNA molecule is produced independently from a chromosome that these uses become possible. Accordingly, this is not a situation in which natural substances “serve the ends nature originally provided and act quite independently of any effort of the patentee.” Funk Bros. Seed Co. v.Kalo Inoculant Co., 333 U.S. 127, 131 (1948).

Invalidating Patents On Isolated DNA Molecules Kills Innovation

According to BIO and AUTM, unless reversed, the decision will cause serious harm to U.S. biotechnological innovation. The biotechnology industry depends heavily on patent protection to encourage the investment of time and capital necessary to develop inventions—including those discovered industrially or in-licensed from world-class universities in support of further academic research—into real-life products. The average cost of bringing a single biotechnology-related therapeutic to market, including basic research, clinical trials, and post-approval testing, exceeds $1.2 billion. Grabowski, Follow-On Biologics, 7 Nature Reviews Drug Discovery 479, 482 (2008). For every successful product, many more are abandoned, often only after large investments have been made (only 30% of biological therapeutics that make it as far as human trials succeed).

A ruling that isolated DNA molecules are categorically ineligible for patent protection would kill investor confidence and interfere with the ability of biotechnology companies, particularly small companies, to attract the capital needed to fund further research and development.

The decision potentially casts doubt on patent protection for a wide variety of natural substances that have been isolated and purified to the detriment of the biotechnology industry and the public.

Patents On Isolated DNA Molecules Benefit Rather Than Harm The Public

As we’ve said before, the issue is not that Myriad has a patent and is withholding treatment from patients.  The issue is that Myriad is charging high prices, which could possibly keep some women from seeking preventative genetic testing.  There is a natural cycle where medical breakthroughs receive patent protection, which allows the patent-holder to charge higher prices. High prices yield high profits, which creates an incentive to develop the next generation of therapeutics and diagnostics.

The question might be better framed as “Who should pay for health care costs as expensive diagnostics become available?”  It would seem to be more productive to focus on what we can do to address health care costs that are spiraling out of control. There is nothing particularly extraordinary about gene patents that should require that they be held to a higher standard than, say, pharmaceutical patents or non-gene based diagnostics, both of which can be subject to high cost and limited availability based on the patent holder’s rights.

This case arose from insurance companies with restrictive reimbursement policies for payment of important therapeutics and diagnostics.  An effort to abolish patents on isolated DNA molecules, however, is misdirected and short-sighted. It mistakes problems in the insurance system for problems in the patent system and will harm rather than help patients in the long run.

It is easy to argue after an invention has already been discovered and disclosed that the public would be better off if it were not patented. It is just as easy to single out a particular invention and argue with the benefit of hindsight that patent protection was not necessary for its discovery and development. Such facile arguments ignore the long-term benefits that the public derives from providing patent protection in exchange for the disclosure of new and useful discoveries.

In the life sciences, early-stage companies hold roughly two-thirds of the future clinical pipeline. Boston Consulting Group, Rising to the Productivity Challenge 6 & Ex. 4 (2004). Without patent protection for isolated DNA molecules, many companies would be unable to see those projects through to completion.

See the BIO/AUTM Brief here:  BIO-AUTM Amicus Brief AMP v Myriad

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  3. I really think what needs to happen is to revise 35 U.S.C. 101. It happens all the time in law, the statute means one thing when its drafted then times and technology change over the next 50 etc. years. Eventually the interpretation of the statute gets more and more stained until it breaks. I think we’re at the breaking point for 101.

    Think about it what are we really trying to protect? We are not trying to protect an isolated a gene or DNA sequence (although this is all thats allowed). The isolation itself is not difficult and in the absence of extensive study and characterization it is meaningless. What we are trying to do is “further the useful arts” by allowing a company, who’s made the huge investment required to figure out what the gene does and discover a useful clinical application, to benefit from their work.

    Lets stop this ridiculous “purified chemical composition” business. We need to go back and make a policy decision on what would best further this area of science in the absence of trying to make a now square peg (language of 101) fit into the same round hole. This matter is to important to be confined to the old interpretations of very different issues.

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