Earlier this week, the ACLU filed suit in New York federal district court challenging the patents owned, by, among others, Myriad Genetics, the University of Pennsylvania and the University of Utah. The suit is little more than ACLU grandstanding in an area in which it lacks any experience or expertise.
The patents in suit deal with certain human genes, mutations of which correlate to increased risk of breast and ovarian cancers in women. That, of course, explains why the ACLU's Women's Rights Project is involved in the suit. While I have a lot of respect for the ACLU generally - I have represented the ACLU in pro bono matters in the past, and would do so in the future in certain First Amendment and other contexts - that respect does not extend to the ACLU's participation in the patent litigation here.
The upshot of the complaint is that the patents in suit should be
deemed to be unconstitutional and/or invalid because society would be
better off without patent protection of these particular genetic
sequences. But that application of hindsight is ultimately destructive
-- virtually every interest group has an interest in practicing for free
a patented method. The ACLU Women's Project wants freer study of breast
and ovarian oncology. Our domestic auto industry would be better off
if it could use for free the drive-train and battery technologies of
the Toyota Prius. The open-source community would prefer to be able to
ignore the software patents of both reputable and disreputable
concerns. Other groups want other freebies, and at the end of the day
we're left with patent protection only for those processes not worth
practicing or protecting.
That this is ACLU bluster is obvious from the gratuities, eccentricities, and omissions from its complaint. A patent complaint ordinarily is a pretty terse legal document that says who the parties are, in this case also why each plaintiff has standing to sue, and a terse assertion that the patents are invalid or unenforceable. A model complaint is available from the federal court system itself. The complaint is ordinarily not a vehicle for standing on a soapbox to yell. Given that the ACLU has little credibility with patent (or other intellectual property) issues it may well lack any other forum to rail against the patent system. Hence a complaint that is gratuitously long and mostly without any legal effect.
The actual plaintiffs represented by the ACLU are doctors and cancer victims whose standing to participate as plaintiffs is dubious. As the ACLU notes in the tail end of its complaint, the defendant pharmaceutical company Myriad has apparently not taken action against researchers conducting experiments (Complaint, paragraphs 97-98). The ACLU claims the patents create a chilling effect on research, but that is not a cognizable basis for declaratory jurisdiction or relief here. (A chilling effect, while sufficient in a First Amendment case, is not sufficient as a matter of law in other contexts including patents.) As to the patient-plaintiffs, their own standing is questionable, as they do not practice any of the patented methods themselves.
There are three basic ways to nullify the defendants' patents here. First is to declare them to be invalid under section 101 of the Patent Act. Second is to argue that the patent owner's bad conduct renders the patents unenforceable. Third is to find the patents invalid, here because they are supposedly obvious over the prior art. I will discuss each of these three challenges briefly in turn.
Section 101 of the Patent Act specifies what subject matter is patentable, and is (slightly) constrained by the U.S. Constitution. Were the ACLU grandstanding less, they would characterize their claim not as whether the patents in suit are unconstitutional but whether they are invalid under a proper reading of section 101 of the Patent Act. The trouble with the ACLU's constitutional argument is that in challenging the unconstitutionality of the patentability of gene sequences, the ACLU ignores settled law, going all the way back to the Supreme Court's decision in Diamond v. Chakrabarty in 1980. The gist of the ACLU case is that genes are not invented but discovered, and that there is something wrong for providing patents for discoveries as opposed to inventions. Denying patent protection for things that can be discovered and isolated is far-reaching: before the gene cases came about, there was a lot of law on how tricky the isolation step needs to be in order for a discovery to be patentable. See, e.g., Janice M. Mueller, An Introduction to Patent Law 226 (2d ed. 2006). As Professor Mueller notes, "the USPTO has a long history of granting patents on purified forms of natural products; for example, the famous scientist Louis Pasteur was awarded a U.S. patent for purified yeast in 1873."
The law as it stands is pretty settled, in a way that is not
favorable for the plaintiffs. Because the law is based on Supreme Court
precedent - to which the lower courts are bound - the ACLU has no
chance of prevailing on this "constitutional" basis until and unless the Supreme Court
takes the case years from now. At present, it seems unlikely that the
Supreme Court is interested in revisiting the issue; the last time the
Supreme Court had the opportunity to do so in the Metabolite case, it demurred, and Justice Souter will have since left the Court.
So, for at least the foreseeable future -- i.e., in the lower courts -- the ACLU's arguments are going to have to be based on unenforceability or invalidity of the patents in suit. But while the complaint requests that the district court find the patents unenforceable, there are no facts pleaded in the complaint to support any legally cognizable theory of unenforceability.
That leaves, as the only remaining theory, patent invalidity. And it may well be that some of the defendants' patent claims are invalid: because they are obvious in view of the prior art or because they are obvious in view of one another (so-called "obviousness-type double patenting"). If some of the patent claims are so flawed, then they should be invalidated. These are complex issues based on the text of the patents, the history of the procurement of the patents, and the scientific literature that existed at the times the patent applications were filed. I suggest that these analyses are beyond not merely the ACLU's expertise, but beyond its competence. Moreover, the issues are wholly unrelated to the admittedly tragic stories of certain cancer victims and survivors, around whom the ACLU frames its complaint.
A lot of the ACLU's moral qualms with the patents in suit deal with
the difficulty of conducting research with gene sequences patented by
others. That is a real problem that can and should be addressed, not by
eliminating patent protection, but by expanding patent law's remarkably
narrow experimental-use exemption. In other years, one might say that
it's too difficult to get Congress to take action to change the patent
laws. But Congress is presently in the midst of reforming patent laws,
and has been busy doing so for the past two years. Where has the ACLU
been?
There are a number of other oddities that leap out from the ACLU's complaint. Among other things, the ACLU (for publicity's sake) has sued the Patent and Trademark Office. This frivolous inclusion of the PTO does nothing but waste taxpayer dollars paying civil-service lawyers to defend the suit until the court lets go the PTO. The PTO acted in compliance with existing law and existing constitutional constructions; it engaged in no unlawful activity. Furthermore, venue is not proper in New York; the federal courts in New York lack the authority to hear a case against the PTO, which the law (35 U.S.C. 1(b)) deems to be a resident of Virginia. Finally, the ACLU has taken an oddly cavalier approach to leaving out of the suit some of the owners of the patents. (See paragraph 29 of the complaint). The owners are always necessary, and ordinarily indispensible, parties to suit under Federal Rule of Civil Procedure 19.
There is far less to the ACLU's complaint than first meets the eye, and it is unfortunate that we cannot debate the validity or invalidity of the patents in suit without the ACLU's histrionics. To the extent anyone should have to suffer this, it should be Congress, not the courts.