AMA, ACLU and Their Friends Oppose (Leahy-Smith) America Invents Act

By Kevin E. Noonan --

The AMA, ACLU, and some of their friends oppose the (Leahy-Smith) America Invents Act, and their reasons may not surprise you.

In separate letters Wednesday to Rep. Lamar Smith, Chairman of the House Judiciary Committee and Rep. John Conyers, the Ranking Member, both the American Civil Liberties Union (ACLU) and the American Medical Association (AMA) opposed H.R. 1249.  While on first blush the basis of their opposition may be surprising (Rep. Debbie Wasserman Schultz's (D-FL) amendment contained as Section 27 of the Manager's Amendment that mandates the availability of "second opinion" genetic diagnostic testing), both groups have much bigger goals and aims than protecting the rights of Americans to a "second opinion."  Despite the propaganda used by both groups (they even had Morley Safer believing it) of the importance of such "second opinions," what these groups are really after is a ban on human (or all) gene patenting.  Whatever the flaws in the proposed "second opinion" amendment (see "Manager's Amendment (and Others) to H.R. 1249 -- Second Opinions in Genetic Diagnostic Testing"), the gene patenting ban pursued by both groups, most recently in the Association of Molecular Pathology v. U.S. Patent and Trademark Office case, is an even worse prescription for the future of genetic diagnostics and other applications of genetic technology.

The ACLU's letter (also addressed to Rep. David Dreier, Chair, and Rep. Louise Slaughter, Ranking Member, of the House Rules Committee), from Laura W. Murphy, Director, Washington Legislative Office and Michael W. Macleod-Ball, Chief Legislative and Policy Counsel, raises as one basis for its opposition the specter that passage of H.R. 1249 containing Section 27 would indicate to courts Congressional approval of human gene patenting.  This argument ignores the reality that Rep. Xavier Becerra (D-CA) has been introducing bills to do just that for several years, none of which has ever even come to a vote in committee.  It also ignores 30 years of USPTO practice granting such patents in the face of political pressure not to do so; in this the ACLU may not be faulted, since the Department of Justice also has amnesia on this topic, so much so that Acting Solicitor General Kaytal argued to the Federal Circuit that the DOJ's position did not represent a sea change in policy (see "AMP v. USPTO: Oral Argument at the Federal Circuit").

The ACLU's letter does a remarkable job in misstating the holding of the Diamond v. Chakrabarty case, changing what the Court actually said, that "laws of nature, physical phenomena, and abstract ideas" are not patent eligible, to read "natural phenomena, products of nature and laws of nature," thus bringing "products of nature" within the patent-ineligible ambit.  And it cites in support its signal victory before Judge Sweet, and in a footnote noting the Department of Justice's "about face" on the issue in (honestly, only partial) support of their position.  The remainder of the letter contains characteristic inapt correlations between the number of Americans suffering from Alzheimer's disease, muscular dystrophy, and various cancers, and the purported "inhibitions on research, treatment, and scientific progress" occasioned by gene patenting, none of which has any empirical basis (and, indeed, the evidence is to the contrary, including the more than 8,000 scientific research papers on the BRCA genes since the patents invalidated by Judge Sweet were granted).

The "real solution," according to the ACLU and its supporters, would be to "allow hospitals and laboratories to develop and offer testing in the first instance," despite the evidence that no one has done so for the overwhelming (~80%) number of genes not patented.  Finally, the ACLU makes sure the Members know that they have God, and many constituents, on their side, citing "patients and their advocates, health providers, scientific organizations, environmental activists and Christian organizations" as their supporters in opposing the bill.  Those groups include Breast Cancer Action, the Center for Genetics and Society, Family Research Council Action, Friends of the Earth, International Center for Technology Assessment, National Women's Health Network, Our Bodies Ourselves, Southern Baptist Ethics and Religious Liberty Commission, and the United Methodist Church -- General Board of Church and Society.  In their letter (attached to the ACLU's letter), is reiterated the ACLU's position, that "patents on human genes present a barrier to second opinion genetic testing" because they "stop[] those labs from examining, testing, and working with patented genes."  (Of course, the scientific evidence shows that the only thing gene patent holders stop is others charging for these services, but that goes unmentioned.)  The remainder of the letter repeats most of the inaccuracies in the ACLU's letter, including the mis-citation to the Chakrabarty holding (in a passage taken almost word-for-word from the ALCU's letter), and including allegations of a rash of other ills from permitting gene patents (littered with phrases like "ownership and sole control over the fundamental building blocks of life" and "monopolistic gene patent holders").

Not wishing to burn any political bridges, the AMA's letter (from Executive Vice President and CEO Michael D. Maves, M.D., M.B.A.) terms Rep. Wasserman's amendment "well-intentioned by flawed," but nonetheless repeats the ACLU's accusation that passage of the amendment "may be misconstrued as authorizing, implicitly, the issuance of patents on human genes."  The group goes on to render an incorrect legal opinion ("[g]enes are products of nature and have never been patent eligible") and falls into the Judge Sweet error (that patenting genes involves restrictions on the genetic information per se).  The letter accurately states that the weakness of the proposed provision is that it is "marked by numerous exceptions" (since an outright ban would be easier to administer) and "would not establish a well-defined pathway for non-patent holders to follow in order to avoid lawsuits."  Dr. Maves also asserts as a possible negative consequence that the provisions could "undermine the ability of physicians to provide optimal care for patients, and further inhibit the development of quality diagnostic tests and access to those tests by physicians and patients."  While undoubtedly his (and his organization's) views, few of its members are involved with "the development of quality diagnostic tests" and, as consumers, like most Americans are most concerned with obtaining the best possible test at the lowest possible cost.  It is hard to criticize Dr. Maves on this score but the facts are that such tests are not so easily developed that intellectual property protection does not influence investment.  And with patents, the public gets the benefits of fixed terms and perpetual freedom to use after patent expiry, something also unmentioned in Dr. Maves' letter; the alternatives are not as favorable to "the development of quality diagnostic tests."

Although it is hard to support Section 27 (and opposition from the ACLU and AMA are not legitimate bases for such support), the provision itself (as with much of H.R. 1249 and its companion S.23) illustrates again how little the operation of the patent system is understood or appreciated even by those who cry the loudest about the need for innovation.  For all its flaws (and for all they have been exaggerated by interests who want to eat their innovation cake and have it, too), the system was an important part of the resurgence of the American economy that resulted in a budget surplus at the end of the last century (however wantonly squandered).  If indeed innovation is the only way for a return to prosperity, attacking the patent system for short-term, nearsighted gain (political or otherwise) is not the smart thing to do.  It's time for Congress to wake up to that reality.

Comments

[6]

I lulzed.

[David Koepsell]

How is a natural phenomenon NOT a product of nature? Explain the distinction, please.

[EG]

Kevin,

What the ACLU says just proves my view of them: they're hypocritical, two-faced, and fork-tongued. They're never troubled by the facts (or science), and especially distorting the facts (and science) to support their point.

David,

You've bought into the ACLU's distortion hook, line and sinker. "Natural phenomena" is something in nature like lightning or gravity: that's what the courts have said is patent-ineligible. "Product of nature" is understood by the courts as something derived or obtained from nature, not nature itself, and therefore potentially patent eligible. A huge difference between these two terms.

[Sherman Akt]

The USPTO is the ONLY US Agency that requires special accreditation to represent clients. An attorney can brief the US Supreme Court, but needs a credential by the USPTO alone, to file a patent application before the USPTO.

If that's not enough, the USPTO now wants to improve US competitiveness by setting and keeping their own fees.

So, in the USPTO we have, a) a 100% monopoly to issue patents, b) with sole pricing discretion, c) deciding who they will work with.

Their shrine to "innovation" should be a tombstone. Anywhere else but the US Government, the antitrust forces would be howling.

[Gary Johnston]

Kevin:

I agree with the opposition to the second opinion thing. If it passes, folks like you will hang your hat on this to support your contention that biomarker correlations (at least nucleic acid-based markers) are patent-eligible as methods. I continue to be disappointed in those that rail against composition patents for isolated nucleic acids, because it lessens their credibility when they argue against method patents for correlating the existence of a nucleic acid-based marker with a trait, which is the REAL problem. It allows people of your ilk to call ACLU et al. delusional or radical. Sort of like a feminist group that wants to replace "manhole cover" with "personhole cover." When the group takes that position, nobody wants to listen to what it has to say on other legitimate problems.

[Kevin E. Noonan]

David: your definition devours the subject matter. Truly, "everything" is a product of nature, so nothing should be patent-eligible. Since that isn't my position, we disagree. (It also isn't my position that iPads should be patentable but life-saving medicines should not.)

Cute picture of your baby doing pushups, by the way. An aspiring gymnast?

[Kevin E. Noonan]

Dear Sherman:

There is a middle ground. Have Congress set the fees (which the Office must justify) but mandate that the Office keep the fees (subject to Congressional audit over what the Office does with the fees). Then you have the best of both worlds.

Thanks for the comment.

[Kevin E. Noonan]

Dear Gary:

I have always agreed that the issue is how to foster genetic diagnostic method development while avoiding a patent thicket. As you know, the district court ignored this issue (in the sense it used less than 5 pages of a 150+ page opinion to say "Bilski), and the furor over "who owns you" has drowned any debate on the REAL issue.

The funny thing (and it came up in oral argument) is if every claim to every gene were to be invalidated, Myriad could still sue anyone who tries to copy their patented method (but they won't have to since they have already reaped the benefits of their patents in establishing their business).

So we agree, mostly, although I think per se rules have unintended consequences, so I am against a per se ban on genetic diagnostic method claims.

"Ilk" is a bit harsh, however.

Thanks for the comment.

[David Koepsell]

No Kevin and Eric your definitions are nonsensical. There is a clear division between an artifact and something that is a natural phenomenon or product of nature. A phenomenon is merely something that is perceived. A natural phenomenon is something perceived in nature, having no intervention by the hand of man. A natural product is the same. Once human intention enters the picture, altering a natural product or utilizing a natural phenomenon, then there is something that is new, non-natural, and perhaps inventive. You can read my thoughts on this here, if you'd like: http://www.bloomsburyacademic.com/view/Innovation-and-Nanotechnology/chapter-ba-9781849664783-chapter-007.xml;jsessionid=A4D227717476ECE94BDFF4A597EE6047

Simply put, I can see no common sense or even legally based distinction between a natural phenomenon and a product of nature, although there are clearly distinctions between nature and its products, and artifacts or artifactual processes. I agree the ACLU should have quoted Chakrabarthy correctly, but conflating natural phenomena and natural products is warranted both linguistically and ontologically.

Thanks, Kevin. Not if she takes after her geeky parents, but who knows, maybe coordination is not genetically inherited?

[David Koepsell]

By the way, EG, the courts have only said that an isolated product of nature may be patent eligible, but in so doing they are not claiming that a product of nature is distinct from a natural phenomenon, as far as I can tell reading the precedent. Rather, it is the act of isolation that allegedly makes something natural no longer natural (which I have disagreed with). It is a strained reading, unsupported by the precedent, to argue that the courts have somehow distinguished between natural phenomena and products ofmnature per se.

[Kevin E. Noonan]

Dear David: as always, we agree to disagree

[EG]

"Simply put, I can see no common sense or even legally based distinction between a natural phenomenon and a product of nature."

David,

My distinction between "natural phenomena" and "product of nature" isn't nonsensical as you suggest. And OK, if you want to nitpick, what the courts have deemed patent-eligible is isolated "products of nature." So like Kevin, we'll have to agree to disagree. And its also your choice to drink the Kool-Aid proffered by the ACLU.

[6]

"Simply put, I can see no common sense or even legally based distinction between a natural phenomenon and a product of nature,"

It doesn't really matter if you can't. The courts created the distinction and they also can see the distinction. What you want to call something which has been acted upon by the hand of man yet is a derivation of something natural is what the courts call a "natural product". Simply adopt their terminology to make the conversation easier Dave.

A rose would smell as sweet by any other name and a natural product would still be a product derived from a natural object by the hand of man by any other name.

[David Koepsell]

6 you aren't paying attention. I want to call anything that has been acted upon by the hand of man "not natural", or an artifact. That's not the distinction I challenge. Try reading more carefully and don't call me Dave. Show me where the court distinguished between anything other that that which becomes altered, through isolation and purification. No precedent distinigusihes between natural phenomena and products of nature, and neither would any disctionary or common sense definitions of the words warrant it. The court's terminology nowhere distingushes a natural phenomenon (which can be either an occurrent or a continuant) from a natural product. The distinction in the law and in common sense occurs when some human intention changes either a natural product or natural phenomenon (making it an isolated or purified product of nature or phenomenon, thus now an artifact, not a purely natural thing anymore). Thus, the claim that a natural phenomenon and a natural product are distinct entities is not borne out by reason or the law. Thus, the ACLU's sloppy quoting still is logical, although not accurate quoting.

[David Koepsell]

And for the record, my argument against gene patents hinges upon my qarrel with the claim that "isolating" a gene from the rest of the genome truly creates an artifact given that the intention goes not to the form of the underlying sequence, but rather to defining borders that I argue already exist in nature. For the same reason, I argue that "isolated and purified" O2 would not be patent eligible although a new process for isolating and purifying it might be. My discussion in my Genewatch article and in my latest book clarifies my argument about the role of intention in defining artifacts, in case anyone is interested in pursuing the debate. I won't reiterate it here.

[Peter Lippman]

As a virtually lifelong and devoted card-carrying ACLU member (and that's a LONG life), I have been very unhappy for the last couple of years about the ACLU's crusade against gene patents. Sadly, ACLU exec Romero and other ACLU leaders seem not to understand what patents are all about. More specifically, Romero et al. apparently think that gene patents are basically just theft of the public's own genetic profiles. This misperception is a result of failing to appreciate that patents are rewards for inventors who bring their innovations forward for PTO consideration, and who MAY get such rewards for a LIMITED time period (typically 20 years from date of application). The patent system is authorized by the U.S. Constitution "to promote the progress of the useful arts", and does provide sensible incentives for inventors (and their employers) to use it. I have tried to explain all this to ACLU management, but they just don't seem to be interested.

[Kevin E. Noonan]

Dear Peter;

Of course the ACLU isn't interested - have you seen their mailings on this issue? In view of its emotional impact, this is red meat for them, and I'm sure they will get a significant increase in contributions because of it.

One thing I think you need to realize - there is no rational debate here (at least with the ACLU); their position is "this is just wrong" on a philosophical level. They are entitled to their opinion, of course. In this blog, we have not tried to counter this argument (which is impossible) but rather set forth our belief that their position leads to outcomes that are at least as wrong (and in our view even more pernicious).

But we are under no illusions that anyone from the ACLU camp will be persuaded.

Thanks for the comment.