The Case or Controversy in AMP v. PTO

By Dennis Crouch

A substantial number of patent lawsuits are declaratory judgment actions that involve a user asking a federal court to rule that it is not liable for patent infringement (either because the user does not infringe or because the patent is invalid/unenforceable). A preliminary issue in these cases is always a determination of whether a sufficient legal dispute exists (a case or controversy) between the parties. Under the U.S. Constitution (as interpreted), a federal court cannot pass judgment on cases that do not meet this threshold. When multiple plaintiffs are present (as in the Myriad case), the court must find at least one plaintiff-defendant relationship that meets this threshold or else the case must be dismissed for lack of standing.

In Myriad, the Federal Circuit ruled that the research of at least one individual (Dr. Ostrer) was hampered by Myriad's patent enforcement activities. Although the court found a controversy in this case, the language that it used to permit the case to continue is quite narrow.

Public Interest Patent Litigation: An important element of the Myriad case is that it has been driven largely by public interest groups operating with an agenda of denuding patents that they see as harmful to public health and fundamental liberties. These parties include the ACLU, PubPat, and the first-named plaintiff, the Association for Molecular Pathology (AMP). Those advocacy groups have no intention of using the patent themselves, but challenging the patent fits within their agenda of protecting the public. In its opinion here, the court holds that those organizations do not have standing in the case.

We … reverse the district court's holding that the various plaintiffs other than Dr. Ostrer have standing to maintain this declaratory judgment action. Simply disagreeing with the existence of a patent on isolated DNA sequences or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court's requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. The various organizational plaintiffs in this suit in particular were not the target of any enforcement action or offered license agreements by Myriad and had made no preparation to undertake potentially infringing activities. They accordingly suffered no injury and thus lack standing to bring this action.

This result obviously makes it more difficult for public interest organizations to take this type of action in the future. However, the court provides a roadmap – simply identify an individual with an actual controversy as the named plaintiff.

Patient / Health Insurance Plaintiffs: Another set of plaintiffs in this case are patients who would like to run the DNA test using an alternative laboratory – either because they want a second opinion or because they want a cheaper test. The court also wrote that those patients likely lack standing to bring a declaratory judgment action in the absence of some affirmative act by the patentee against those defendants.

Certain patients also allege an injury based on their inability to gain access to affordable BRCA genetic testing because of Myriad's patent dominance of such services. While denial of health services can, in certain circumstances, state a judicially cognizable injury, Plaintiffs have not pressed this as an independent ground for standing. Moreover, we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.

This quote from the court conforms well to the Supreme Court's recent copyright decision Golan v. Holder (2012). In that case, the court wrote that individuals do not have enforceable rights to use the "public domain."

In a sense, it appears that the court here strained to claim jurisdiction over the case, but was careful to attempt to avoid expanding the scope of declaratory judgment jurisdiction in the process.

11 thoughts on “The Case or Controversy in AMP v. PTO

  1. Anon, under the AIA, things may be different.  But today, the second inventor's patent is invalid, right?  Even so, third parties clearly cannot bring suit to invalidate the patent without an accusation of infringement.  But is the same true of the first inventor?

    Just to clarify:  there are no lawsuits pending, no accusations of infringement, and no relationship between the first and the second inventor.  The first inventor does not have a patent, but he does have a product and a business build around his invention.  In the patent law sense, his invention is not abandoned.

    Does he have standing to sue to invalidate the second inventor's patent?  If he had a patent, he could file suit under 291.  But he does not have a patent.

  2. Ned,

    I am having trouble following your rebuttal to Dorothy.

    Did you leave out parts of the fact pattern?
    Are you asking if the first bonafide inventor is trying to bring an infringement suit against a third party?
    Are you asking if the first bonafide inventor can bring suit against the second inventor?
    Is there any relation from the first bonafide inventor to the second?
    Are you asking about a suit in derivation?
    Are you asking about a straight up DJ action?
    Is there a threat against the first bonafide inventor from the second inventor?

    Keep in mind too that this sounds like you only have inchoate rights there Ned (if there is no deriviation issues, etc)…

    Of course, with the AIA, the first bonafide inventor may also have the new prior user rights, but the timing is not clear from your example, and I am not sure how those rights affect standing independently of the first inventor not being targeted by the second inventor.

    In either case, the first bonafide inventor certainly does not have patent rights, so if he is attempting to bring suit over a patent that he has no right to, then the answer is no, he does not have standing (for example, alone and on his own in an attempt to bring suit against a third party).

    Of course, if you are talking about a third party being targeted by the second inventor and the third party learns of or knows of the first inventor, a license/purchase agreement can drag the first inventor in and make things messy (my understanding is that such would not invoke the prior user rights, which are a “personal’ defense, but if the third party has purchased from the first inventor, the second inventor’s patent rights are extinguished and yes, that happens with no benefit whatsoever accruing to the second inventor.

    But of course, back to the point initially raised by HtGNaH (and which Dorothy was pointing out the straw of your 8:20 PM, Aug 17 reply), what we have is yet another example of how validity is not material to a court challenge.

  3. OK, Mr. Dorothy, assume a bone fide prior inventor who did not file a patent application, but only wants to use the invention he made, and made first. He has not been accused of infringement, yet. But he has a fear that his clients may be sued for infringement by using his products and/or services.

    Does he have standing?

    Again, this is a bona fide prior inventor and a patent has issued to a second inventor.

  4. Thanks for the response, I See Dead Issues.

    I will try to be clearer in response. As to the first issue, the Federal Circuit did toss the organizational and health-care plaintiffs; I happen to think that this may have been wrong given the treatment of such plaintiffs in other areas of the law (think, for instance of environmental law, which has a rich tradition of standing for organizational plaintiffs). Again, the question is whether or not patent law is fundamentally different than other types of law?

    As to the second issue, I will try another to ask it in another way: can you have a “bare” validity challenge to a patent under the DJA? This is what really is at stake in this case, if you think about it. The plaintiffs (unlike true competitors) might want to challenge the validity of the patents without significant use as they might think that the patent is invalid (much like a statute that violates the Constitution). The question is whether we want a patent regime that permits these types of challenges.

  5. Not sure about your first question Kali.

    The alleging of sufficient injury is not the be all and end all of the standing question, and regardless of how the name of the case is writen, the orgnizational plaintiffs were tossed on standing, were they not? Thus, your attempt to paint this as a “patent law stands different” does not reach.

    Your second point is garbled and unclear.

    What does the reference to a “constitutionally infirm statute” have to do with this case?

  6. Two questions present themselves in AMP. First, the organizational plaintiffs have alleged sufficient injury under the constitutional standing test for organizational plaintiffs, as typically understood in Lujan and Sierra Club. The question is–once again–whether patent law stands alone in its claim that it is doctrinally distinct from other areas of civil procedure. Medimmune and E-Bay present a clear challenge to patent law’s claim to a separate civil procedure. Indeed, even under Lujan, it is clear that the health-care plaintiffs have stated a cognizable claim.

    Second, the question of “validity” challenges under the DJA have always presented conceptual difficulties for the patent regime. The current test in many respects conflates “use” injury that is typical for infringement challenges (i.e., a potential infringer files a DJA so as to “use” claim) with the, perhaps, broader set of injuries that may exist with regards to a validity challenge (which might be seen more as a broader set of injuries can arise when a constitutionally infirm statute exists). I am not entirely sure whether the drafters of the Patent Act of 1952 figured out how to “square” this challenge but I do believe that the Federal Circuit is failing to fully acknowledge this set of issues.

  7. OK, I’ll byte. Assume the ACLU identifies a that Myriad did not name Joe Blow as an inventor, and Joe Blow claims to have discovered the BRCA gene and its association with certain types of cancer. Joe never filed a patent application of that invention, has no documentation, has no known relationship with Mryiad or any other inventor and is a known kook.

    Can the ACLU file a declaratory judgment action seeking a declaration that the Myriad patent is invalid or not owned by Mryiad or whatever based on the public interest?

    What if the ACLU obtains an assignment from Joe Blow? Does the fact that Joe allegedly independently invented the same invention give you any jurisdiction to challenge Myriad’s ownership of the invention?

  8. A preliminary issue in these cases is always a determination of whether a sufficient legal dispute exists (a case or controversy) between the parties

    Ned, please note that this is where issues of standing can (and do) arise (independent of AIA and validity).

  9. However, the court provides a roadmap – simply identify an individual with an actual controversy as the named plaintiff.

    Was this a particularly well-kept secret? The “roadmap” has always been “be a plaintiff who has an actual controversy”.

    The reason AMP was listed first is not because they thought they had an actual controversy. It’s well settled that feeling bad about what somebody else is doing doesn’t entitle one to relief – same reason MercExchange didn’t get its injunction. AMP is a named plaintiff in this case because AMP wanted to have its name on the case. It’s more grabby than “Doctor Who? v. Some Non-famous Biotech Company”.

    I guess this case also gives us the roadmap for doing that – marketing. Because everybody is calling it the “ACLU case” or otherwise identifying the ACLU as a party, even though they’re not.

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