WFU Law Professor Says Federal Circuit Failed as "Keeper of the Constitution" in AMP v. USPTO

By Donald Zuhn --

In an article published in The Huffington Post on Sunday, Wake Forest University Law Professor Simone Rose accuses the Federal Circuit of failing in its duty as "keeper of the Constitution" with respect to the Court's July 29 decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  Noting her background as a former registered patent attorney, Professor Rose writes that one question came to mind as she read the majority and concurring opinions, namely "[h]ow can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity?"  She argues that "[c]hemically modifying an isolated gene [i.e., "breaking . . . chemical bonds during the isolation process"] does not alter its biological heart (nucleotide sequence)," and that "[a]ccurately detecting BRCA mutations would be impossible without this biological identity."

As for the focus by the majority and concurring opinions on long-standing USPTO practice in issuing gene patents and on the impact an affirmance would have had on the biotech industry, Professor Rose (at left) contends that while "promoting innovation is a laudable goal, the Federal Circuit's broadening of what constitutes patent-eligible subject matter missed the bigger Constitutional target."  According to the Professor, the Constitution's Patent Clause requires that the granting of exclusive rights under the patent system be balanced against providing access to basic knowledge.  She therefore concludes that "[p]atenting products of nature such as isolated genes and gene sequences prevents access to these basic research tools during the term of the patent," and "[t]his impedes rather than promotes progress and is therefore in direct violation of the IP clause."

Professor Rose argues that federal courts have an obligation, as "keepers of the Constitution," to ensure that their analysis of 35 U.S.C. § 101 and controlling case law is "in harmony with the Constitutional mandate to promote progress of the useful arts."  She contends that in AMP v. USPTO, "[t]he Federal Circuit should have taken this role seriously and upheld the lower court's invalidation of the BRCA isolated genes and gene sequence patents as patent-ineligible subject matter."

Interestingly, for Professor Rose, the end result of the invalidation of Myriad's patents would be Congress weighing in on the issue of gene patenting.  Unlike the majority and concurring opinions, which state that if the law is to be changed, it is up to Congress and not the courts to change it, Professor Rose believes that a finding by the Federal Circuit of invalidity would have permitted (or encouraged) Congress to step in and "legislate a new 'Constitutional' framework of exclusive rights for this subject matter."  Looking forward, the Professor says that she remains "hopeful" that the Federal Circuit sitting en banc or the Supreme Court "will be mindful of its role as the keeper of the Constitution and interpret the Patent Act's subject matter limitation to exclude the BRCA genes as patent-ineligible products of nature."  She argues that an "appropriate legislative dialogue" on a solution that balances access and innovation can only begin after the courts determine that gene patents should be excluded as patent-eligible subject matter.

Comments

[Dan Feigelson]

Funny, here I thought the constitutional role of patents was "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries". It's hard to see how undercutting an entire industry, one which has given us several useful drugs and seems poised to give us more in the future, accomplishes that goal. And last time I checked, the isolated DNA sequences claimed by Myriad aren't found in nature. But I guess Ms. Rose missed that part of the court's decision.

Maybe they should change the institution's name from WFU to WTFU.

[EG]

Don,

Oh give me a break! With all due respect, Professor Rose's comment that she's a "former registered patent attorney" is apt. She shows a complete lack of any reality (or understanding) of patent-eligiblity issues under 35 U.S.C 101, not to say her complete lack of understanding of chemistry and molecular biology. Her comment about the federal courts having an obligation, as "keepers of the Constitution," to ensure that their analysis of 35 U.S.C. § 101 and controlling case law is "in harmony with the Constitutional mandate to promote progress of the useful arts" is reminiscent of the inane (and flawed) dicta by SCOTUS in Graham about the constitution imposing "limitations" on what Congress could deem patentable.

What Professor Rose spouts about the AMP case is utter rhetorical nonsense as far as I'm concerned. She should go back to her "Ivory Tower" and stay there. And consider the source of this article: the Huffington Post. What else could you expect from a known left-wing rag?

[Snarky McGurk]

I guess WFU is the place to study patent law . . . or maybe not.

[Bob S.]

The "keeper of the constitution" argument is specious. All the Constitution says is that Congress shall have the power "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." If you believe that an isolated gene is a discovery made by an inventor, then it's constitutional. If you do not believe that an isolated gene is a discovery made by an inventor, then it is not constitutional. Because the Constitution does not itself define what is meant by a "disovery" made by an "inventor," it is hardly a failure "to keep the Constitution" simply because this author has a different viewpoint of discovery than the majority in the AMP case. While I respect the views of those who believe from a public policy point of view that isolated genes should not be subject to patent protection (I obviously hold the opposing viewpoint), I don't think it is proper to drag the Constitution into the fray. This is not a constitutional issue. It is a public policy issue to which the Constitution does not speak, especially given the fact that the framers in eighteenth century could hardly have envisioned discovies in the arena of molecular biology.

[CM]

Her comments typical of the set that believes money grows on trees. Apparently Prof Rose believes that innovation, products, and services, also just spontaneously leap from nature onto the clinician's shelf.
Patent exclusivity is for a limited time to allow a return on investment for the research necessary to even discover the link between "the gene" and the disease. No USPTO registration number is needed to understand these principles.
PS - Prof. Rose, if you believe the gene in nature is the same as the isolated DNA, try using some homogenized cells for your cancer test (doesn't work very well, I assure you).

[BioPatAtty]

Way to destroy your own credibility, and an otherwise very decent post, by whining about where it was printed.

Fail.

[RG]

From Rose's article: "If the BRCA gene patents were invalidated, Congress could then step in and legislate a new "Constitutional" framework of exclusive rights for this subject matter. Congress would likely gather industry, academic and public stakeholders together to craft a hybrid statute that would promote innovation as well as provide much-needed access to these basic upstream research tools." I was going to comment on this but there's so much to say, I didn't know where to begin.

[EG]

BioPatAtty,

If you're referring to my comment regarding The Huffington Post, then I've got news for you: it is well-known" (not just by me either) as a "left-wing rag," and one that's not known for providing a balanced viewpoint. I'm also sorry if you feel that characterization undermines the "credibility" of my post, but I'm just trying to set the context of why something like Professor Rose's article would appear in such a newspaper.

[General Admission]

I guess you lose your registration number when you become a "former registered" practitioner? Just wondering, as the PTO does not have her listed on its roll. In any case, I am consistently bothered by the consistent lack of evidence in support of the assertion that "gene" patents inhibit basic research.

[lorac]

"[h]ow can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity?"

I've read this question several times and cannot make any sense out of it. Seeing as I was trained in molecular biology and a current registered patent attorney and can't understand it, me thinks that she is clouding the discussion with such nonsense. Twas brillig and the slithy toves did gyre and gimble in their wabe...all mimsy were the borogroves and the mome rathes outgrabe - makes more sense than professor Rose. Jes' sayin'

[6]

A great article by an equally great author is all I see in this hea thread.

[6]

"I am consistently bothered by the consistent lack of evidence in support of the assertion that "gene" patents inhibit basic research. "

I will sign a dec or make testimony that "gene" patents inhibit me from performing basic research.

[EG]

"A great article by an equally great author is all I see in this hea thread"

Consistent, as usual, 6 (in the misspelling of words), as well as ignorance of the facts (i.e., technology), law and our Constitution. I don't mind opposing views, but what this professor asserts is completely unsupported on the facts (i.e., technology) and the law. That this professor says such nonsense is understandable given that she's apparently clueless on the technology involved (that she doesn't understand chemistry or molecular biology is consistent with the fact that her technical background is in EE/computer science). I'll also repeat my past friendly advice to you from the Harry Callaghan School of Patent Law which this professor should have also heeded: "a man/woman's got know his/her limitations when it comes to the law and technology."

[6]

She makes an idealistic argument EG, what are you qqing about? There is nothing wrong with noting how the system should be working despite its many shortcomings leading you to the opposite conclusion.

[EG]

Well, 6, we didn't reach "common ground" here (i.e., we disagree on this professor's view). But that's OK too. Peace and "Live Long and Prosper" /making a Spock Vulcan Greeting/Leaving Sign with right hand/