Government Follows Public Sentiment on Myriad Case: Should Firms Be Surprised?

On October 29, 2010, the U.S. government filed its amicus brief in the so-called ACLU v. Myriad case (more commonly captioned AMP v. USPTO due to the listing order of the parties at interest) (see report from NYT).  This is the case relating to the patentability of genes used in breast cancer detection that I've written about here and here.  The brief has caused a stir among commentators that adds to the already voluminous writing on this case because the government has advocated for the unpatentability of DNA.  This is contrary to its previous stance (the government is even a co-owner of four of the patents-in-suit).  Actually, the government's position is somewhat constrained, suggesting only that unmodified, purified DNA sequences are in the public domain.  DNA with modified sequences should be eligible for patents, according to the government (assuming they meet the other criteria of for patenting).  This middle ground would preserve a many of the patents relied upon by the biotechnology community.  Still, commentators like Patent Docs' Kevin Noonan argue that such a rule, if adopted, could have an impact on many firms:

However, there is real danger that the bases for the government's arguments with regard to "merely isolated" human genomic DNA apply to all "natural products"; the same rationale that the government improperly applies to come to its conclusion that merely "isolated" DNA is not patent-eligible can be (and will be) applied to any other naturally-occurring substance, including antibodies, antibiotics, antisense and small interfering RNAs (siRNAs), hormones, metabolites, and proteins, precluding them from patentability . . .

Many commentators have expressed surprise at the nature of the government's brief.  The government has previously taken the position that isolated DNA, even if identical in sequence to strands existing in nature, should be as patentable as other extracted chemical products.  In fact, it has been noted that PTO attorneys appear to have been left off the brief, suggesting that there may have been some internal disagreement.  The idea that politics may be playing a role in framing the legal analysis has been asserted. 

But, in the end, how much of a shock was this brief?  While I certainly did not predict the government's position, on reflection, I can't say that I'm all that surprised.  I have been teaching patent law to non-law students for years, and the patentability of DNA is one topic I feature in my classes.  As each semester brings new news about the ease in sequencing DNA and a general understanding how central it is to our individuality, I find that students (and non-law faculty colleagues) have become progressively more skeptical of its ownership through patents.  Even those interested in working in the biotech industry -- traditionally the most dependent on DNA patents -- have voiced concerns in recent years.  While I have long thought of this as relatively settled law (though it has never been directly litigated), and I appreciate the logic in the granting patents for isolated DNA, I can see that the tides may be shifting.  This issue may be far more viable than many in the pharmaceutical and biotechnology industries realized.   

In many ways, one might see the progress of this case as yet another warning against relying on complex legal doctrine that may be at odds with public sentiment.   Similar to the issues that arise when one presumes that everyone understands online privacy rights, when a company is liable for product defects, what constitutes fair use in copyright law, how much BP should pay for the Gulf oil spill, and what all those terms mean in a mortgage document, there is a danger when the development of the law diverges from public expectations.  How we address this -- whether with more education or revision of the law --  depends on the purpose and benefits of the legal doctrine itself.  While legal rules are not subject to constant reassessment by popular vote, one must acknowledge that the legal structure is impacted by current public opinion.  And it's risky for corporate America to invest on the premise that complicated and unintuitive legal rules will necessarily survive and provide protection.