Nature Biotechnology and More Anti-gene Patenting Myths

    By Kevin E. Noonan --

Sadly (you'd expect they would know better), the editorial board of Nature Biotechnology has decided to get on-board the anti-gene patenting bandwagon.  The editors are entitled to their opinion, of course, but it shouldn't be too much to ask that they be more informed about the issues.

This development appears as an editorial in the May edition of the journal.  Entitled "Sitting up and taking notice," the editorial announces Judge Sweet's March 29th decision in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office.  That announcement marks the last time the editorial makes completely factual statements, tending instead to promote the idea that gene patenting is a problem by inference direct and indirect.

For example, the editorial characterizes the procedural aspects of Judge Sweet's decision, on summary judgment, as indicating that "the judge felt Myriad had no case to argue."  This is incorrect:  summary judgment is used when there are no disputed issues of material fact, and the court finds that it can decide the matter as a matter of law.  The prudence of this judgment can be questioned, not merely on the basis that the judge actually chose to make law on patentable subject matter by deciding that DNA is sui generis as "the physical embodiment of genetic information."  The editorial also is mistaken in stating that "[t]he plaintiffs won on virtually every count," in view of the fact that the District Court avoided the Constitutional issues that were the basis for the Court to deny defendants' motions to dismiss.  This is not a trivial matter, since as a consequence the PTO was dismissed from the case, and without these issues the breast cancer patients had no standing to bring the suit in the first place (not to mention that these are the issues that created the political frisson for the ACLU and PubPat).

The editorial also continues to mistake the effects on research of the BRCA patents with the use of these patents to prevent infringing, for-profit commercial activity.  The editorial states that "Myriad's influence has been particularly pernicious.  Its lawyers have issued cease-and-desist letters to genetics laboratories in universities, hospitals and clinics that offered diagnostic services based on the BRCA1 and BRCA2 genes."  These uses of the patented tests constitute infringement -- the fact that the infringer is a university, hospital, or clinic doesn't absolve them from for-profit, commercial, infringing activities.  The difference between this type of activity, which is not "research" (although the results can be used for research purposes) is in stark contrast to the several thousand basic research papers in scientific journals that have been published since the BRCA gene patents were granted.  That is where the research to support innovation is occurring, not in university, hospital, or clinic labs doing fee-based, diagnostic assays for patients, and there is no evidence that Myriad or any other gene patent holder has inhibited basic biological research by threatening patent infringement litigation.

The piece also attempts to achieve "truth by association" in noting the several groups that have "concerns" about gene patents, including the International Center for Technology Assessment, Greenpeace, the Indigenous Peoples' Council on Biocolonialism, and the Council for Responsible Genetics, all of whom filed amicus briefs in the case.  Their contribution to the debate would be more welcome if it did not include patently incorrect statements regarding the consequences of gene patenting, including "the privatization of genetic heritage, the creation of private rights of unknown scope and consequences and the violation of patients' rights."  The editorial was correct in noting that "[t]he alignment of physicians' and patients' groups with what are, in effect, antibiotech lobbyists is a worrying development," albeit ignoring the fact that not only the biotech sector but the public should be worried if these groups should get their way.

The editorial did supply a data point for the debate, in noting that Myriad reported "$326 million in revenue from diagnostic testing against $43 million in costs."  Assuming these numbers to be correct, and to reflect only BRCA testing, an indication of the profitability of BRCA testing results (perhaps unintentionally providing a motivation for the "universities, hospitals, and clinics" to be so keen on getting into the business, infringing or no).  However, the figures are completely out of context; there is no indication if these profits are out of the ordinary for diagnostics companies, traditional or genetic, or whether the "costs" include ancillary costs like genetic counseling or physician education (both critical in genetic diagnostics due to the consequences for a patient of receiving a genetic diagnosis).  Surely, if Myriad's profits were actually significantly higher that other companies, that fact would be relevant and the absence of any comparisons suggests that the absolute numbers were used because they better supported the editorial's views.

Then there is the portion of the editorial that seems divorced from reality:

It often seems unfair that the patent system rewards only the last inventive step -- the small breakthrough that enables a concept to be realized.  The research enterprise, which continually renews itself, especially in rapidly moving areas like genetics, is increasingly at odds with the commercial conservatism of patent monopolies based on gene findings that are obsolescent compared with current art.  Despite both cultural and economic incentives for innovation, the difficulty in dislodging incumbent approaches is reinforced by a patent system that insists that any use, however small, of a protected method is infringement.  Is it so outrageous to expect that a properly functioning IP system could provide an unobstructed path to the market both for the initial innovators and for subsequent improvers?  Surely, a different balance of rights is possible that better serves the society with whom the patent bargain has been struck.

The patent system rewards inventors who disclose how to make and use an invention that is new, useful, and non-obvious.  Whether the improvement is groundbreaking or incremental, satisfaction of the statutory requirements governs patentability.  Thus, if technology becomes "obsolescent," new technology takes its place -- if only because patents expire, as indeed Myriad's patents will start to expire in 2014.  The passage indicates just how little the writers understand the "balance of rights" that the patent bargain actually strikes.

Finally, the editorial does touch on the coming issue of patent protection for methods of detecting specific genetic polymorphisms and techniques such as whole genome sequencing that could infringe such patent claims.  These are not "gene patents" per se, since they involve assays on genes (actually, fragments of genes) rather than the genes themselves.  The editorial thinks little of "patent pools" as a means for overcoming the potential issues, stating that such mechanisms "are not going to emerge in biotech of their own accord" and ignoring how the (unregulated) computer and telecommunications industries have developed just these types of patent pools.  Instead, the editorial posits that it will probably take some form of government or legal coercion to get things moving for gene tests, disagreeing with the recommendations for such tools from the U.S. Health and Human Services SACGHS report.

The editorial ends by exhibiting a consistent lack of understanding of innovation as well as the patent process.  It suggests assigning rights to specific genes in multigene tests based on "the importance of any specific gene sequence to the utility of the test," something the marketplace can be counted on to do without the government's help.  Saying that the "early gene mutant discoveries . . . now look trivial" (!), such a approach is suggested to provide incentive for "those who continue to develop tests of high medical value with commensurate financial remuneration."  Those "trivial . . . early gene mutant discoveries" are certainly not trivial to the patients benefiting from diagnostic assays or therapies based on them; moreover, if by "trivial" the writers meant "amenable to early discovery" that is just a reflection on the strength of the phenotype resulting from the mutation.  And while the last sentence of the piece was clearly meant to be exhortative:

That this ideal is implausible within the current petrified patent system and commercial infrastructure doesn't have to stop the dream, and certainly shouldn't stop the discussion.

It is merely incoherent:  the dream of better diagnostics and therapies is and has been realized by thirty years of biotechnology and protection thereof by an invigorated patent system in the U.S.  Changing that now, particularly if based on the wooly-headed arguments (really, sentiments) in the Nature Biotechnology editorial, is the fastest and surest way that those hopes and dreams will be dashed.

Comments

[Noise above Law]

There are none so blind as those who choose not to see.

[EG]

Kevin,

The factual inaccuracy in this popular media piece doesn't surprise me in the least in this day and age. Why bother with the facts when "Kool-Aid" drinking will suffice. Just proves my point that journalism as we once knew it is completely dead.

[Kevin E. Noonan]

The problem, EG, is that NB is not the popular media. Which in some ways makes it worse.

Thanks for the comment.

[6]

"It often seems unfair that the patent system rewards only the last inventive step -- the small breakthrough that enables a concept to be realized. The research enterprise, which continually renews itself, especially in rapidly moving areas like genetics, is increasingly at odds with the commercial conservatism of patent monopolies based on gene findings that are obsolescent compared with current art. Despite both cultural and economic incentives for innovation, the difficulty in dislodging incumbent approaches is reinforced by a patent system that insists that any use, however small, of a protected method is infringement. Is it so outrageous to expect that a properly functioning IP system could provide an unobstructed path to the market both for the initial innovators and for subsequent improvers? Surely, a different balance of rights is possible that better serves the society with whom the patent bargain has been struck."

Eloquent. To the point. On point. Reflective of the views that will become more prevalent as the non-information of yesteryear gives way to the information abundance we experience today.

Fact is, all our IP systems are horribly out of date. Designed as they were for a world where information and education was scarce. There are still sectors that merit such protection but they are far fewer than we currently provide it for. But the system will change to accomodate this development eventually.

And Noise you're absolutely right. You should take off your blindfold of refusal.

[Skeptical]

Eloquent of... what exactly?

The quote offers no replacement system, just a kvetch that the writer doesn't not like the current system.

[EG]

Kevin,

I stand corrected on NB. You're right, it does make it worse as NB should know better.

[CNS]

Excellent analysis Kevin. As I've suggested previously, I hope you also post your comments on the appropriate section of Nature Biotech's website and/or as a letter to its editors.

[6]

"The quote offers no replacement system, just a kvetch that the writer doesn't not like the current system."

Now that the topic has been brought up, go ahead and suggest one.

Personally I believe that a likely winner is more custom tailored term lengths for various arts, more compulsory licensing, or a form thereof through damages reform, etc. etc. Notably this will likely entail a change from the "exclusive right" with attached injunction of yesteryear to the "right to part of the proceeds" from commercial activity involving the invention. Indeed, Ebay was a gigantic step towards this already, more is probably on the way.

What's more is that it seems rather reasonable.

Something akin to this will likely go down in copyright by the time I'm Kev's age.

[Kevin E. Noonan]

Actually, 6, the passage might apply to certain crowded electromechanical arts, where your expertise lies. Certainly other commentators have suggested as much, and if the passage were in Nature EE I might have no trouble with it.

The problem is that the editorial ran in Nature Biotechnology, and it just doesn't describe the facts and how patents and that technology co-exist (and how the technology has thrived, as has traditional pharma, under the current patent regime). (Even Besson and Maurer agree that this sector is the only one where patents seem to be worth the trouble.)

So while I think there are some inklings that enforcement of certain patents may be weakened by decisions like eBay, I haven't seen a case where a pharma or biotech company making a product was denied an injunction after prevailing in a patent infringement suit. Look at Judge Young's decision on whether or not to grant an injunction in Amgen v. Hoffman-LaRoche, where the court heard evidence that the price of a "generic" drug could actually cause a short-term increase in overall drug costs to patients before prices would fall. It isn't as simple in this art (and remember that most non-practicing entities in the space are not "trolls" but universities, who are much harder to villify by infringers trying to freeride on other's inventions).

Just some thoughts. Also, don't presume you will get to be my age - I didn't when I was your age (and at times the odds were against it).

Thanks for the comment.

[bigredbruce]

"patent pools" as a means for overcoming the potential issues, stating that such mechanisms "are not going to emerge in biotech of their own accord".......disagreeing with the recommendations for such tools from the U.S. Health and Human Services SACGHS report."

While I agree that your overall argument in defense of system is markedly better than that delivered by NB editorial, I find the above passage a tad disingenuous. The SACGHS reports predicates its comments on potential usefulness of pools based on formation of an advisory committee (Rec #4 pg 93)to provide input on future policy changes or proposed recommendations in its report. However, its Rec #1 (pg 90) and Rec #2 (pg 91) are respectively 1) Create an exemption from liability for infringement for diagnostic testing, 2) Create an exemption from patent infringement liability for pursuit of research. Only gene patents supporting the development of a therapeutic would be protected. Given those pre-requisites, of course voluntary pools could be seen as viable.
I happen to favor pools too but the SACGHS recommendations woud certainly go a long ways toward stacking the deck in their favor - and given implementation of Rec 1 and Rec 2 - how much would pools be needed?

bigredbruce
http://thebigredbiotechblog.typepad.com/the-big-red-biotech-blog/

[6]

"Actually, 6, the passage might apply to certain crowded electromechanical arts, where your expertise lies."

Meh, I wouldn't say that my expertise quite lies there. I have some limited experience with that nonsense, and many of my buds were more involved with sensors etc. But while it is a promising field, it appeals to me just about as much as designing engines for lawnmowers. Maybe less because it is so much harder and more of a pain in the arse.

"Nature EE "

Lol, how about one of IEEE's monthly pubs?

"The problem is that the editorial ran in Nature Biotechnology, and it just doesn't describe the facts and how patents and that technology co-exist (and how the technology has thrived, as has traditional pharma, under the current patent regime). "

I haven't read the whole piece, but perhaps it describes the facts and how patents and that technology co-exist and how the technology would have thrived sans patent regime? Lol, jk, I know what you're saying.

The fact is Kev, this piece applies likely across the board to many fields beyond our own. And I'm fine with that.

Btw, Idk how often you keep in touch with your ex, but I really appreciated her standing up to the majority in the recent Miranda rights case. She should know that there are many out here applauding her sensible approach to the law in that case and that we believe it was a real shame for the majority to hold the way they did. Even though I can understand their reasoning as well, it seems as if a different basis for the decision would have been in order.

[Chanel]

I stand corrected on NB. You're right, it does make it worse as NB should know better.

[Chanel]

Eloquent of... what exactly?