Thursday, August 27, 2009

ACLU gene patents challenge -- Bilski preview

Lori Andrews and I today filed a motion and an amicus brief on behalf of the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York in Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, et al., No. 09 Civ. 4515 (RWS) -- the lawsuit filed by the ACLU and the Public Patent Foundation challenging the BRCA1 and BRCA2 gene patents owned by Myriad Genetics. ( I discussed the case earlier this summer on the Kojo Nnamde Show, with Hans Sauer of the Biotechnology Industry Organization and Shobita Parthasarathy of the U. of Michigan.) The case will provide a good opportunity for the courts to resolve whether isolated natural materials and discovered medical phenomena are patentable subject matter. We argued that in a series of cases over the past 150 years, the Supreme Court has held that one cannot patent (1) products of nature, or materials isolated from products of nature if those materials behave in the same way they would in nature, or (2) discovered laws of nature or mathematics, or applications of those laws lacking significant (i.e., creative) “post-solution activity.” We also explained how some of the claims at issue (the sequence claims) cover the natural materials and being "isolated" does not change them nor give them new properties, and how other claims (the correlation claims) cover the mental act of recognizing or comparing information, however obtained. Finally, we explained how these patents have interfered with our clients' research and have prevented proper medical care, and why they violate both medical and scientific ethical tenets.

The brief is a good preview for my forthcoming Supreme Court amicus brief in Bilski v. Doll, as it demonstrates in the contexts of products of nature and natural phenomena the relevant patentable subject matter requirement that there must be invention in the application of scientific principles, naturally occuring materials, and abstract ideas. Historic ethical obligations required treating previously known or newly discovered science, nature, and ideas as not only "free for all to use" but also as if they were already in the prior art (once disclosed, e.g., in a patent application). Thus, in order for there to be any patent-eligible "invention" there must necessarily be some other "inventive concept" (using the terminology of Parker v. Flook) in the application itself of the discovered science, nature, and ideas, even if the application is novel. Simply isolating the natural genetic material is not sufficient to be called "invention," given that the discovery of the natural material must be treated as if it were already known. Similarly, claiming the isolated genetic sequence information or variants of it (in mutations) is not an invention once that information is requiredto be treated as public domain information (as natural phenomena). And claiming the acts of comparing the actual genetic sequence disclosed in the patent to another (potentially mutated) sequence is not an invention, given that there is no creativity in doing so once the sequence information is treated as in the public domain -- recognizing that one of these things is not like the others is trivial even if highly useful. (It also destroys the quid pro quo of the patent system -- an enabling disclosure where people can use the information -- if not the physical implementation -- in exchange for patent rights. Note that this is different from but the mirror image of the bargain-destroying problem caused by the lack of a meaningful research exception, when people can't use the information disclosed in the patent to sequentially innovate because they can't use physical embodiments that are necessary to research. Although combinatorial chemistry and biology may minimize that problem, some of the patents at issue in the AMP v. PTO case actually prohibit "analyzing" sequence information, however it might be obtained.)

Chris Holman (a friend and a colleague on a recent paper entitled Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents, the draft of which is on SSRN and the final is published at 23 Berkeley Tech. L. J. 1299 (2008)) has provided a good short summary of the ACLU's motion for summary judgment that our amicus brief supports on his Holman's Biotech IP Blog. Chris appears to recognize that the Supreme Court precedents before Diamond v. Chakrabarty (which as discussed in our amicus brief did not change the law in this regard) require more than "mere isolation" in order to claim a patent-eligible application of a product of nature. Chris also correctly notes that the Patent Office has for a long time treated mere isolation as sufficient human creativity and difference from the natural material to constitute a patent-eligible invention. So we will have to see if the District Court (and ultimately perhaps the Supreme Court) is willing to disregard various appellate court decisions (pre-dating and of the Federal Circuit) and the PTO policies that contravene the Supreme Court precedents, when the consequence is to eliminate thousands of claims in a very important industry. For the reasons explained in the medical association amicus brief, there are good policy reasons to do so because these patents cause real harm.

This case also reflects another "industry battle," this time not IT or generics against pioneering PhRMA, but the medical treatment/scientific research community (and the patient and consumer community as the ultimate beneficiaries) against the biotech/scientific research community. And it is precisely the tension in the scientific community (which spans both industries) that makes this so fascinating. As the amicus brief discusses, scientists had an ethical duty (deriving from the morality of religion) not to subject to private property rights their discoveries of nature -- which duty remains reflected in the patent law requirement that such discoveries must be treated as prior art if disclosed. As William Robinson stated over a century ago in his celebrated Patent Law treatise, "To benefit by the discoveries of his fellow-men is thus not only a natural right, it is also the natural duty which every man owes to himself and to society; and the mutual universal progress thence resulting is the fulfillment of the earthly destiny of the human race.” As Lord Camden said a century earlier, scientists are "entrusted by Providence with the delegated power of imparting to their fellow creatures that instruction which heaven meant for universal benefit; they must not be niggards to the world, or hoard up for themselves the common stock." Are scientists who seek to (and often successfully) patent their natural discoveries bad people?


  1. Describing the line between what is and is not patentable in the context of modern technology is certainly not easy. Certainly effort and creativity are important factors.

    I cannot agree, though, that isolating a gene is automatically not patentable. First, that religious ethics of some undescribed sort prohibit this is, besides an establishment of religion, an ipso facto kind of argument, of no weight. Second, that it interferes with universal benefit or impairs some treatments is an argument that proves far too much.

    It would outlaw patenting any drug or medical device. Congress has already decided the balance, and it allows, as does the Constitution, monopolies/royalties on drugs and devices because the monopolies and royalties are incentives to the research that make new treatments possible.

    If you want to discuss changing to a socialist economy, or tweaking the amount of monopoly (e.g. years duration, regulated royalties, etc.) I am all eyes.

  2. Phil:

    Thanks for the comment. Since you are the first person to comment on the blog, I am particularly grateful for your having done so, even if I beg to differ. First, as described a little in the brief we just filed, Congress has not authorized these patents -- even the Supreme Court in Chakrabarty indicated that what was needed was a synthetic creation with a significant new function, and isolating DNA does not meet this standard even if the new oil eating bacteria in Chakrabarty would have. The companion case to Chakrabarty -- Bergy -- would have tested the isolation issue (for a yeast), but the applicant (or his counsel, having read Parker v. Flook decided two years earlier) decided to withdraw the claim.

    But even if you were right, legislative action may exceed the Constitution's grant of legislative power. Reasonable minds can differ regarding what the Constitutional limits are. So I won't debate the issue now, but only say that history may matter to constitutional interpretation -- including deeply held religious beliefs of the Framers -- without it constituting "establishment." How else can one understand the cruel and unusual punishment interpretations as other than moral beliefs, either of the Framers or of more modern interpreters?

    More to the point, your comment about patenting drugs or medical devices raises two separate issues -- first whether Congress has made the relevant determination and second whether prohibiting patents on such "inventions" would be a bad thing for society (because patent incentives for such "inventions" are needed AND even if needed outweigh the costs and harms the patents may impose). Again, reasonable minds may differ on this, but that is beside the point. If the drug did not contain any invention (which some argue that, e.g., new combination pills do not -- e.g., a combination of a known antihistamine and decongestant), it is not clear why that should be patent eligible. And even in "advanced" Western countries like Germany, patents on medicines were prohibited until the 1980s.

    The issue thus seems almost like the tax code -- the idea of progressive taxation has retreated so far from the public mind that it seems inconceivable that things could be and in fact were different, and that many parts of the world did think it was immoral and therefore legally prohibited patents on medicines. But almost all countries in the world prohibit patents on medical methods -- and it is hard to see why if that is correct patents on medicines should be treated differently (except perhaps that we need the incentives for medicines and not for medical methods). Rather, it raises the question of whether there are better ways to fund the costs of research and development of medicines -- and some of our best economists are saying that prize systems may be preferable to exclusive rights. If this is what you mean by a socialist economy (by involving the government to direct and fund medical research and development), then perhaps it would indeed be a good idea. But the government does already fund much of the science for drug development, and it is only the Bayh-Dole Act that makes it "inevitable" that patents will issue for needed medicines (as well as medicines the market will support but are much less important -- whether second-line treatments or so-called recreational drugs).

    Again, thanks for commenting, and I wanted to reward your post with a full response -- whether or not it convinces you. But keep your eyes out for my Bilski brief -- which I hope will least convince you that "invention in the application itself" is the law because it was the law prior to the 1952 Act and Congress did not intend to change it (and has not done so since), notwithstanding adoption of the revision to Section 101 to permit patents for new uses of old things!



  3. I think the framers clearly had no idea what a biotech patent might look like. Microbes as a cause of disease were decades off, and bleeding was a common "remedy", supposedly to let the bad whatever out of the blood. Geo. Washington was bled in his final illness, and it may have killed him.

    I think the patent laws are plugged into both the patent clause and the commerce clause, giving Congress plenty of juice to do it their way, in view of current science and technology. I also would still be troubled looking at religious texts for either what is a cruel and unusual punishment or what is a patentable invention. Where does that leave the writings of the atheists and agnostics?

    But I doubt there are any moral (broader than religious) writings from the 1790s that really help us when the Framers had no concept of DNA, let alone bad bacilli. I prefer to apply their actual words to what's up now.

    So the question is what should be patentable under what we know of biology. It is harsh to say a substance extracted from nature and found safe and effective is patentable--those who cannot afford the royalty built in the drug price don't get well. So fix the health care system so all can afford the drug. Maybe make drug development a regulated public utility.

    NIH gives grants, in decreasing amounts as the years pass, to the most conservative applications, because of peer review. (They would not have supported research into a bacterial cause of ulcers, because every doc knew it was bad diet; yet it was a bacterium.) And no NIH grant is going to cover half a billion or more to do an FDA approval process. It must be private capital (unless the entire economy suddenly becomes socialist). A patent is the only property right or similar right that can provide RIO for a billion dollar investment. Again, then, reform health care financing to regulate the RIO, but killing the patent kills the incentive entirely instead of modulating it.

  4. Nor did the Framers have any idea commerce clause power would be extended so far, or many other things. But what they did have very clear ideas about was framing basic principles in general terms so that they could be adapted to changing conditions, including new technology. So the concept of placing the discovery of science in the public domain serves well today, even if it was not contemplated just what kind of science -- and what kinds of conditions scientists work under. It is in this sense -- the sense of fundamental values (which were informed by religion but are not less moral principles if now divorced from their religious origins and believed by atheists) -- that informs the current discussions. And moral principles are what judges often do decide on, whether they try to support those principles by reference to beliefs of the Framers, religious texts, social consensus, surveys, or just their own opinions (which in many cases would be more direct). And it is precisely the moral principle that science should be free for all -- developed in writings from the 1790s -- that remains very highly relevant to modern disputes over patenting DNA.

    As for financing returns on investment, I do believe that patents on pharmaceuticals (at least new chemicals entities having significant new or significantly improved efficacy) are justified by the need to provide ROI for clinical trials -- so long as other appropriability mechanisms are not employed. But that ROI could be funded by market exclusivity without patents (as has been proposed for biologics), or by prize funds (as has been proposed at much lower system costs) by economists, or by direct government funding (ex post or ex ante), which you can call socialist if you prefer. What is indisputable is that the "socialist" US Government funds large amounts of the science -- not the trials -- and it is the science that we are discussing in regard to the patents and ownership.

    Finally, yes there are many ways to modulate the incentive. How about direct federal regulation of the price of pharmaceuticals or the licensing contracts that such companies can enter (like public utility regulation of electric supplies)? Or at least abrogating the federal government's agreement not to bargain with pharma companies over the medicare reimbursement policies? Or restoring a meaningful "research with" exception to avoid sequential innovation losses? Any number of policy levers can be used to modulate rights and affect incentives. And one of those policy levers is not granting the patents in the first place when they either are not needed or cause net harm. And also, although actually no less controversial and perhaps not even less difficult to prove or reach consensus over than the last two, when they are considered immoral.



  5. Let's not forget that patents provide a LIMITED monopoly for what is today an ever decreasing period of time to recoup high investment costs. As Phil mentioned, the current model for fueling innovation and investment is this limited patent monopoly (20 years now calculated from the time of FILING a first patent application, despite multiple years in both USPTO prosecution and FDA approvals). In exchange, the public gains full disclosure and access to the disclosed invention after the limited monopoly period. During the patent monopoly period, researchers are given a safe harbor under 35 USC 271(e) to conduct research that is reasonably related to the development of data that would be important for FDA approval of new drugs and diagnostics (e.g., not market resarch).

    These important innovations are one generation's gift to the next and will cease without appropriate stimulus and support. The flexible and expansive US patent system has welcomed many new technologies and stimulated great advances in pharmaceutical development. It is currently poised to promote unimagined biological advances in disease treatment and prevention. Do we really want to destroy this potential without having ready a replacement system adequate to at least replicate what is available now?

  6. I'm listening, but having a hard time seeing how far the proposed invalidations extend. "Gene patents" are an easy target, but most drugs are isolated natural products, or minor variations thereof. Would you deny patent rights on drugs like paclitaxel (taxol), isolated from tree bark (or coral)? All "natural" antibiotics isolated from fungi? I worry that you might disincentivize the pioneering discoveries, rewarding patent rights only to minor follow-ups.

  7. For my responses to the last two comments, see my new post (and sorry for the delay).