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District Court Rules ACLU Gene Patent Challenge May Proceed


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
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Posted: November 2, 2009 @ 9:56 pm
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In perhaps the worst opinion I have ever read from any federal court, the United States District Court for the Southern District of New York ruled earlier today that the ACLU challenge against the Myriad Genetics patents and the United States Patent and Trademark Office for issuing patents can proceed. Procedurally the posture was a Motion to Dismiss, which are granted only in rare and extraordinary cases. What makes this decision surprising is that District Court Judge Robert W. Sweet, the 87 year old judge who has been on senior status since 1991 and who was appointed by President Jimmy Carter, recognized that there is no valid basis to bring this lawsuit but allowed it to proceed anyway. Truly amazing!

The United States Patent and Trademark Office correctly argued that the judicial branch should not be engaging in a review of the granting of gene patents or with respect to allowing for an the patent and patent claims to be challenged where there is no redress allowed by law. The United States Congress has created an highly specific regulatory regime relating to patents, and there is simply no basis in law to bring this case. With respect to this argument Judge Sweet wrote:

While the USPTO notes the existence of a comprehensive scheme to redress violations of the Patent Act, it cites to no comparable statutory scheme providing a remedy for persons who complain about the constitutionality of patents issued by the USPTO and/or the policies and practices of the USPTO. See Block v. Cmty. Nutrition Inst., 467 U.S. 340, 349 (1984) (“[Wlhen a statute provides a detailed mechanism for judicial consideration of particular issues at the behest of particular persons, judicial review of those issues at the behest of other persons may be found to be impliedly precluded.” (emphasis added)); see generally Marbury v. Madison, 5 U.S. 137 (1803). In such circumstances, the Supreme Court has held that Congress did not intend to preclude enforcement of federal rights through private actions. See Wright v. Roanoke, 479 U.S. 418, 427-28 (1987) (citing absence of statutorily defined private judicial remedy for alleged violation of federal housing law as evidence that Congress did not intend to foreclose private right of action). Indeed, even when Congress has created a statutory remedy, if that remedy is not coextensive with the remedy provided by the Constitution, plaintiffs may still bring a separate action to enforce the Constitution. See Fitzgerald v. Barnstable Sch. Corn., – U.S. – t 129 S. Ct. 788, 796-97 (2009).

The novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiffs’ claim against the USPTO.’ See, e.g., Reno v. ACLU, 521 U.S. 844 (1997); Mace v. Skinner, 34 F.3d 854, 859-60 (9th Cir. 1994).

Then Judge Sweet turned his attention to standing.  The defendants raised the legally correct point that there is simply no standing to sue and challenge the USPTO or these patents.  After accurately pointing out that prudential standing requirements dictate that the judiciary should avoid deciding questions of broad social import where no individual rights would be vindicated, and that prudential standing requirements require a party to assert their own legal interests rather than generalized grievances or grievances of third parties, he then ruled there was standing.  Judge Sweet explained:

The Defendants allege that it is well established that third parties do not have standing to challenge the USPTO’s issuance of a patent. The authorities cited by the USPTO, however, address a party’s standing to bring claims for statutory violations and establish only that the existence of a comprehensive framework within the Patent Act designed to address certain statutory violations may demonstrate Congressional intent to foreclose a judicial remedy for those violations. -See Syntex, 882 F.2d at 1572-74; Hitachi Metals, 776 F. Supp. at 7-8; Godtfredsen v. Banner, 503 F. Supp. 642, 644-45 (D.D.C. 1980) (finding statutory remedies for claims of examiner error during interference proceedings precluded judicial review of the proceedings prior to the exhaustion of administrative remedies).” As discussed supra in Section IV, these cases do not, as the USPTO suggests, establish that the remedial scheme provided by the Patent Act for statutory violations divests the Plaintiffs of standing to assert constitutional claims for which the Patent Act provides no remedy.

The USPTO also argues that the Plaintiffs do not have standing because the injuries alleged are not “fairly traceable” to the USPTO’s allegedly improper conduct. The “fairly traceable” requirement “examines the causal connection between the assertedly unlawful conduct and the alleged injury.” Allen, 468 U.S. at 753 n.19. While the USPTO is correct that Myriad’s refusal to license its patent broadly contributes to Plaintiffs’ alleged injuries, the patents were issued by the USPTO, in accordance with its policies and practices. It is those policies and practices that the Plaintiffs allege are unconstitutional. The injury alleged is therefore “fairly traceable” to the USPTO.

Finally, the USPTO argues that Plaintiffs’ claim against it fails to meet the redressibility requirement, which “examines the causal connection between the alleged injury and the judicial relief requested.” Allen, 468 U.S. at 753 n.9. The Plaintiffs ask the Court to enjoin the Defendants from taking any actions to enforce the challenged claims in Myriad’s patents. Fairly included in this prayer for relief is a request that the Court declare unconstitutional the USPTO’s policies and practices with respect to the challenged claims and similar classes of claims. Granting Plaintiffs’ request for relief would serve to render the claims-at-issue definitionally invalid. As a result, the Plaintiffs would be allowed to engage in conduct currently prohibited by Myriad’s patents, and the alleged injuries would be redressed.

In short, this is the most embarrassing display of judicial activism I have seen in a long time, perhaps ever.  Despite there being no foundation in the law to bring this action, and despite the grievances being only of a generalized nature, Judge Sweet is allowing the case to continue.  Does it surprise anyone that he was appointed by President Carter?  Probably not, but what should be surprising is that an 87 year old man who elected to take senior status some 18 years ago is being given a case with such enormous consequences for the patent system and the US economy.

Whether Judge Sweet cares to admit it or not, there is simply no basis for this challenge to the Myriad Genetics patents, or to the USPTO issuing gene patents. The testing in question in this case will not help anyone treat cancer, it won’t even tell them if they have the cancer, it will just tell them whether they are genetically likely to develop cancer. This is hardly a life-saving situation, but the fate of an entire industry and the advances it could bring to future generations hangs in the balance. Kill the genetics industry and there will be no funding from private entities to spur the research and development necessary to bring advances to market and to the public.

The plaintiffs argue that federal funding has been provided, and that is correct. But make no mistake about it — federal funding relates to pure science and pure science cannot and never will have any place in the market. It is private industry that builds on the pure science discovered at Universities. Universities cannot and never will bring anything to market, which is why they need private industry partners. Without a partnership between Universities and the private sector advances simply will not mature into commercially viable products, services or diagnostic tests. Kill the incentive for the private sector and you kill the industry, which is recklessly stupid, but even more so now when we have such a fragile economy.

I have every confidence that in the end this frivolous lawsuit will be revealed as such, but at what cost in the meantime?  Perhaps Judge Sweet will come to his senses in time to rule on the inevitable summary judgment motions, but based on the tone of this ruling I fear that as long as he is assigned to this case the Defendants are in for a long road.

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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patent Litigation, Patents, USPTO

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

 


14 comments
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  1. “After accurately pointing out that prudential standing requirements dictate that the judiciary should avoid deciding questions of broad social import where no individual rights would be vindicated, and that prudential standing requirements require a party to assert their own legal interests rather than generalized grievances or grievances of third parties, he then ruled there was standing.”

    yes, because he finds that individual rights of plaintiffs would be vindicated, and that they have asserted more than generalized grievances or grievances of third parties. He finds that the cease and desist letters from Myriad amounted to an ongoing, actual injury, for instance.

    The lawsuit is not frivolous, there will be no Rule 11 sanctions, no dismissal on standing, and now we’ll get to the merits. As I have stated from the beginning, the case makes a cognizable constitutional claim, and federal pleading requirements are liberally construed. So, now, let’s see what happens. No matter what the decision on SJ in the district court, this is going up to SCOTUS, and it’s going to be very interesting to see what happens!

    best,
    David

  2. Dave,

    With all due respect, I agree with Gene that the constitutional challenges to these gene patents are absolutely unsupportable and frivolous no matter what facts might be presented. And with all due respect to the judge here, he’s turning this case into a farce to continue to allow these constitutional challenges to these gene patents to proceed forward. Since Chakrabarty v. Diamond, SCOTUS has said that life forms may be patentable subject matter. That implies that the genetic material or testing procedures based on that genetic material may also be patentable subject matter. SCOTUS in Chakarabarty saw no “constittuional Issue” in patenting life forms or its genetic material, nor do I. That the judge’s opinion spends a mere 4 pages on the constitutional challenge issue (after spending 80 pages) just highlights the absurdity of allowing this issue to proceed forward.

    Interestingly, there is absolutely no mention of the suffiiciency of this Complaint under 35 USC 101 as to whether these patents cover merely a “product of nature.” That’s the only issue that might have any merit to go forward, at least to a motion for summary judgment. But as I said before this opinion came out, these constitutional challenges have absolutely no merit to go forward.

  3. Again, opponents of the patent are bringing emotion into the courtroom and not facts.
    The patenting of this method does provide benefit to society as Myriad Genetics paid a lot of money to identify the best possible marker for breast cancer, develop an assay for this marker, conduct clinical trials to demonstrate it’s efficacy and bring this product to market. Rather than spending large sums of money to fight this technological advance, why doesn’t the ACLU develop a “design around” test or open a free BRCA screening clinic in one of the 130+ countries where the test is not patented. They could try the Bahamas or South America because Myriad has protection in Mexico, Canada, Australia and Europe.
    Just because they don’t agree with the way Myriad is enforcing it’s patent doesn’t mean they shouldn’t have the right to protection. If they feel that lifesaving inventions should not get patent protection, then apply it to all lifesaving inventions including airbags, parachutes, safety equipment, fire alarms, “OnStar(r)” and any other device that may possibly save a life if everyone had one.

  4. “Interestingly, there is absolutely no mention of the suffiiciency of this Complaint under 35 USC 101 as to whether these patents cover merely a “product of nature.” That’s the only issue that might have any merit to go forward, at least to a motion for summary judgment. But as I said before this opinion came out, these constitutional challenges have absolutely no merit to go forward.”

    Dave and Gene,

    Having now reviewed the patents involved, let me correct this statement I made earlier: there is no basis under 35 USC 101 for challenging these patents either. The claims are to isolated genetic material or methods for identifying/screening/detecting. In other words, the patentee isn’t simply claiming a “product of nature” (the claimed isolated genetic material doesn’t exist in nature).

    To put it bluntly, the plaintiff’s allegations that these patents cover “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought” are utterly groundless and complete rhetorical nonsense. As far as I’m concerned,this suit is a complete waste of judicial resources. I can only hope that the Federal Cirucit will trounce this opinino when it gets the appeal.

  5. Quinn seems to be grossly mischaracterizing the opinion. Whether the plaintiff has standing or not, Quinn’s arguments don’t mesh with the quoted passages.

    I.e. Quinn says there is no statutory basis for the case:
    “The United States Congress has created an highly specific regulatory regime relating to patents, and there is simply no basis in law to bring this case “.

    But the judge clearly states his basis is Constitutional not statutory:
    “Indeed, even when Congress has created a statutory remedy, if that remedy is not coextensive with the remedy provided by the Constitution, plaintiffs may still bring a separate action to enforce the Constitution.”

    Quinn then claims the defendants have no personal injury or relief to justify standing:
    “The defendants raised the legally correct point that there is simply no standing to sue and challenge the USPTO or these patents … [P]rudential standing requirements dictate that the judiciary should avoid deciding questions of broad social import where no individual rights would be vindicated, and that prudential standing requirements require a party to assert their own legal interests rather than generalized grievances or grievances of third parties”.

    But the judge clearly states the plaintifff’s personal injury and relief:
    “Fairly included in this prayer for relief is a request that the Court declare unconstitutional the USPTO’s policies and practices with respect to the challenged claims and similar classes of claims. Granting Plaintiffs’ request for relief would serve to render the claims-at-issue definitionally invalid. As a result, the Plaintiffs would be allowed to engage in conduct currently prohibited by Myriad’s patents, and the alleged injuries would be redressed.”

    It sounds like Quinn is grinding an ax against Jimmy Carter rather than reading the actual decision. I’m not saying the suit has merit, but this post doesn’t address that.

  6. Edward-

    No ax to grind, just calling it straight and accurate, unlike Judge Sweet. The fact that the most liberal President in history appointed Sweet explains a lot, and it was certainly fair to point that out. Liberals always point out when a judge has been appointed by a Republican President when they disagree with a conservative ruling, so fair is fair and context needs to be provided to understand Sweet’s judicial philosophy. Activist judges do what they want, and with life tenure that creates enormous burdens on society.

    Every first year law student knows that you cannot bring a cause of action on a constitutional basis just because you want to do so. If that were the case the courts would be littered with Constitutional cases, and they are not. You must have standing, and quite simply there is no standing here. Judge Sweet recognizes, correctly, that there is no statutory basis to bring the claim, so there can be no standing as a result of a statute. Judge Sweet then accurately explains prudential standing, explaining that a general grievance cannot be brought. He also recognizes the authority that says a policy question should not be addressed by the courts, and then proceeds to ignore those cases and all other rules and regulations that demand judicial restraint.

    With respect to your erroneous understanding of personal injury, what the plaintiffs are requesting is essentially a form of declaratory judgment, and they simply do not have any interest that is any different than the general public. Myriad has not threatened to sue them. If this case is allowed to go on then anyone who has no money for a patented technology, device or method can sue to claim that the Patent Act is unconstitutional. That is nonsense. These plaintiffs have suffered no injury, and learning about their future is not a right granted by the Constitution. Regardless of what Sweet ruled, they have suffered no recognizable legal injury.

    You can believe I didn’t read the decision if that makes you feel better, but I did read the decision and I am right. Judge Sweet is wrong, and any Constitutional scholar who is honest knows that to be the case. The ACLU should not be rejoicing. While they will undoubtedly receive favorable treatment in Judge Sweet’s courtroom there is absolutely no chance that the ACLU will ultimately prevail. Whether it is as a result of an appeals court correcting his obviously flawed and incorrect decision, or as a result of Congressional action.

    -Gene

  7. Gene,

    I’ve focused my beef primarily on the ridiculous (and unsupportable) allegations is this Complaint that granting patents covering isolated genes and methods for identifynig/detecting/etc. can be unconstitutional or that covering isolated genes is inconsistent with 35 USC 101 (it’s not). But your points about standing are well-taken. The only way Congress has authorized a challenge to validity in the PTO on a patent is by reexam, and it doesn’t include issues relating to constitutionality of the original patent grant or issues under 35 USC 101.

  8. [...] District Court Rules ACLU Gene Patent Challenge May Proceed [...]

  9. [...] the case, but because important constitutional rights are at stake the case can continue.  See District Court Rules ACLU Gene Patent Challenge May Proceed. So if this case is not on your radar screen it needs to be on your radar screen because this is [...]

  10. Gene,

    You’re claim that patent 5747282, doesn’t patent a gene is without foundation.

    Claims 8 an 9 of the patent application specifically make it a patent violation for any person carrying the gene.

    Specifically, the natural process of cellular replication violate the patent. Here read it for yourself:

    8. A replicative cloning vector which comprises the isolated DNA of claim 1 or parts thereof and a replicon operative in a host cell.

    9. A replicative cloning vector which comprises the isolated DNA of claim 2 or parts thereof and a replicon operative in a host cell.

    The human body is a replicative cloning vector, and some humans clone that gene in isolation of other genes, for at least some time frame no matter how minute, and always inside a host cell, with a replicon operative. The reproductive act of persons with this gene would also isolate the offending genes, and pass them on to the newly created embryo.

    So somebody discovered cancer causing genes and wrote a patent around it, so no doctor could even look for the gene using standard and non-innovative testing methods, and then tacked on what “may be” a unique way of looking for it. By so doing they preclude anyone looking for the gene in any manner. Now what was it they “invented” that deserved a patent?

    See how dangerous “gene” patents are?

    Now if they have some unique way that modifies the gene and fixes the flaw, that’s truly spectacular and go ahead and give them a patent on the treatment. Or if they have discovered this gene can only be found by some new and novel approach then sure patent that, but let’s strike from the patent all the pre-existing methods of looking for it.

    By what I read of the patent, all researchers are now precluded from searching for a cure to the cancer causing genes, (claim 20). Even ways they haven’t though of. How is this a good thing and not a 1st amendment issue? Please, I’d really love to hear your argument on this specific point (claim 20).

    See, that’s the real problem, is there are too many fields of useful arts and science and not enough qualified patent examiners. Patents should be looked at by experts in the field, or fields, of the patent. Then we’d get rid of junk patents and overly broad patents, and we’d get only really good solid innovative patents. Of course, it’s put a lot of patent attorneys out of business, because we’d have a patent system that actually worked for what it was intended for. And the patents granted would be rock solid.

  11. Jack-

    Are you admitting that the ACLU claims that the method patents are genes is frivolous?

    -Gene

  12. “Such vectors may be prepared by means of standard recombinant techniques well known in the art and discussed, for example, in Sambrook et al., 1989 or Ausubel et al. 1992.”

    There are no “replicative cloning vector” DNA naturally occuring in the human body. “Recombinant” by definition is modified by man.

    No one skilled in the art of recombinant DNA would read a “replicative cloning vector” on naturally occuring DNA in a virus, bacterial DNA, or human.

    Please provide another example where you read the limitations that are present in the claims.

    Mike

  13. US5747282 Claim 20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

    The BRCA1 gene must be altered and the eukaryotic host cell must be transformed, although not expressly stated in the wording, the eukaryotic host cell must be transformed with a BRCA gene. Therefore it does not preclude all cancer screens, only screens designed in recombinant BRCA cells.

    This is called a reach-through claim, because the claims are directed to a screen of BRCA cells, they are looking to license or garner royalties from BRCA interacting drugs. The value and legitimacy of these claims is difficult to assess. They have not identified any particular cancer treatments, yet try to claim unknown compounds that may interact with BRCA. If the ACLU were challenging this claim on an enablement argument, their case would be stronger. Of course, there is no evidence that Myriad stopped people from screening BRCA or have collected royalties on BRCA interacting therapeutics.

    It is easy for you to come in 20 yrs after the fact and say, “that is easy!” You are asking why they got claims in an application that was filed 15-20 yrs ago. The techniques and sequences are commonplace. The ability to identify genes expressed under differing conditions has also improved in the last 20 years. Your arguments use hindsight with today’s technology to downplay a discovery made when technology wasn’t as advanced.

    It’s easy to design a phone that has no keys and uses only a touch-screen. Why would that ever be popular?

    People have used typewriters and letters for years, how could there ever be a new novel if they all contain the same letters and the same words? All you’re doing is changing the order, thus there are no new novels (books or songs).

    Mike

  14. [...] § 101. Nevertheless, as we await a decision in Bilski, and the Southern District of New York is confronted with a lawsuit challenging the constitutionality of the US patent system, and in particular the granting of gene [...]

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