A U.S. District Court recently held that patent claims directed to breast cancer-linked genes, and claims on methods for using the genes, are unpatentable subject matter and therefore invalid. Association for Molecular Pathology v. United States Patent and Trademark Office, 2010 U.S. Dist. LEXIS 35418, Sections IV.A, VIII et al. (SDNY April 5, 2010). We have discussed this case in our April 2010 Newsletter. The district court's holding has sparked lively debates in the patent community on the benefits and drawbacks of allowing patent monopolies on human genes.
The holder of the invalidated claims, Myriad Genetics, reportedly enjoyed revenues of about $200 million in 2008 alone for testing covered by these patent claims (Id. at Section III.D.2), and has, not surprisingly, announced it will appeal the district court's decision. Myriad's decision to appeal is also not surprising because the district court's holding seems unlikely to be upheld on appeal, as it attempts to overturn several decades of USPTO grants of gene patents and solid U.S. caselaw supporting the patenting of genes.
Why would a judge choose to buck the system this way, to engage in a holding so against precedent and so likely to be overturned in an appeals court? A lesson learned during early years of patent prosecution may hold the answer—rejections under one point of law may include elements of another. To overcome such rejections, one must frame arguments in the language of the rejection while addressing what is really bothering the Examiner.
The district court struck down the claims as unpatentable subject matter, but really seemed to perform a test balancing benefits and drawbacks of patenting genes. Facts of the case included testimony that women unable to pay Myriad's monopoly price went untested for gene mutations that would indicate whether they were at high risk for breast cancer; that Myriad sent cease-and-desist letters to physicians offering to perform genetic tests for their patients; and a discussion of the general impact of Myriad's patents on research on the patented genes. (Id. at Sections III.D-E). Possibly, the district court was swayed by moral arguments and so legitimized previously unpersuasive arguments on subject matter patentability to invalidate Myriad's gene patents.
Morality arguments in the patent field are best exemplified in the European Patent Office, where inventions may be denied patent protection if it is deemed contrary to morality. For instance, in 2008 the European Patent Office Board of Appeals held that claims directed to destroying human stem cells are immoral and therefore unpatentable subject matter. Claims directed to mammals genetically modified to develop cancer were limited to only mice, in view of suffering inflicted on animals by the invention. These holdings create controversy at the international patent level, in view of arguably complimentary and contrary treaty provisions, for instance in the WTO TRIPs Agreement. If upheld, the above district court decision will do the same.
The U.S. does things a little differently. We do not ask the USPTO to consider the morality of inventions when determining whether claims are patentable subject matter, but rather limit the use of patented or unpatented inventions with criminal and other laws. Certainly, morality considerations came into play when the Congress enacted 35 USC 287(c), indicating that patent claims directed to pure surgical methods of treating the human body are not enforceable against medical practitioners in U.S. courts (See our December 2009 Newsletter). Also, compulsory licensing and other laws are in effect to limit patent monopolies when necessary for public health reasons.
The district court judge, swayed by his conscience, appears to have indulged in judicial activism that will be, if upheld on appeal, a calamity to the U.S. patent and biotechnology systems. Patents on other chemicals will be vulnerable to invalidation on the same grounds; companies will move away from public disclosure to protect their inventions through other laws where possible (e.g. test data and trade secret laws); trends toward harmonization of international patent laws will be strained. Hopefully, our appeals courts will remember that subject matter patentability is not the proper place for a moral discussion on U.S. patents.
Vol. 53, June 2010