The battle over “gene patents” continues: the Department of Justice brief

by David Resnick on November 4, 2010

Human GeneticsIn an earlier Vector post, I explained that Judge Sweet’s decision in The Association of Molecular Pathology v. The United States Patent and Trademark Office (also known as the ACLU v. Myriad case), invalidating Myriad Genetics patents on BRCA1 and BRCA2 DNA and testing, was only the first step in a long process to a final decision.  The next step was Myriad’s appeal to the Court of Appeals for the Federal Circuit, the federal court that hears all appeals in patent.  Myriad did file an appeal and as part of that process, interested parties were invited to file amicus curiae or friend of the court briefs.

Last week, many in the life sciences community were shocked when the Department of Justice (DOJ), representing the U.S.  government, filed a brief advocating for a change in policy on  the patent-eligibility of isolated genomic DNA.  The brief makes a distinction between isolated DNA that is the subject of “human manipulation” (such as cDNA), which it argues is patent-eligible, and human DNA that has been merely “isolated,” which it argues should not be patentable.  On its face this may seem like a reasonable position, however, its not—for a number of reasons.

First, the DOJ is taking a position that directly contradicts  the policies of the Department of Commerce (by and through the U.S.  Patent and Trademark Office) and the National Institute of Health.  These policies  have been in place for over 30 years. The DOJ admits this, but says that after reviewing the Myriad district court decision, it now realizes that–all these years later–the government was wrong. Talk about uncertainty–the US government doesn’t know if it’s coming or going. For over 30 years, the US Patent Office has been issuing the types of patents the DOJ now says are not patent-eligible. To make matters more confusing , now the director of the Patent Office, David Kappos, told the Dow Jones news service: “The USPTO at the present time is maintaining the status quo. We’re continuing with current procedures as they are.”  So now you have one government agency  contradicting another.

Not only is the position of the DOJ wrong legally, it does nothing but erode confidence among biotech investors at a time when investment in the industry is already suffering. Given the state of our economy, shouldn’t the government be doing something to foster and promote investment in healthcare, not hinder it?   Investments of tens or hundreds of millions of dollars in technology licensed from the government is now hanging in the balance.   A “sorry, we changed our mind,” is a not sufficient remedy.

Another legitimate fear is that the DOJ’s position will be used to attack patent-eligibility not just of DNA-related technology but of other isolated and purified compounds, including therapeutic proteins. This would further weaken investment interest in life-saving technology.

At this point, the damage has been done. While we wait for the Federal Circuit to render a decision, its important to remember the goal of the patent system is to encourage investment and commercialization of nascent technology. Without that investment, many life-saving technologies will never make it from the lab to the patient. While the system isn’t perfect, it’s all we have—and it has worked pretty well for us this far.

2 comments

  • http://twitter.com/oleg8r Alex Kentsis

    I agree that issues surrounding protection of intellectual property are not trivial and can have far-reaching consequences, but in the case of patenting the use of gene sequences in general, and with respect to Myriad’s patent of BRCA in particular, the representation of this post is oversimplified and incomplete. Legal arguments notwithstanding, such patents can limit the availability of tests to patients and their use by doctors, as not all patients can afford the several thousand dollar cost, and labs cannot provide verification of test results because of possible patent infringement. And finally, though difficult to assess rigorously, such patents can have deleterious effects on the scientific and medical progress itself, as Myriad’s patent extends to the fact that BRCA mutations cause cancer, and therefore can hinder development of novel diagnostics and therapies (consider for example the recent development of PARP inhibitors to treat BRCA1 deficient cancers). This has been discussed at length in the literature, and needs to be mentioned.

  • http://twitter.com/oleg8r Alex Kentsis

    I agree that issues surrounding protection of intellectual property are not trivial and can have far-reaching consequences, but in the case of patenting the use of gene sequences in general, and with respect to Myriad’s patent of BRCA in particular, the representation of this post is oversimplified and incomplete. Legal arguments notwithstanding, such patents can limit the availability of tests to patients and their use by doctors, as not all patients can afford the several thousand dollar cost, and labs cannot provide verification of test results because of possible patent infringement. And finally, though difficult to assess rigorously, such patents can have deleterious effects on the scientific and medical progress itself, as Myriad’s patent extends to the fact that BRCA mutations cause cancer, and therefore can hinder development of novel diagnostics and therapies (consider for example the recent development of PARP inhibitors to treat BRCA1 deficient cancers). This has been discussed at length in the literature, and needs to be mentioned.

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