By Kirell Lakhman

Let’s be honest: AMP’s gripe with current gene-patenting rules has nothing to do with patenting genes or with its desire to exempt certain labs from infringement claims for using patented genes to develop lab tests. If it were, the organization would have been up at arms when the first human genes began winning patent protection years ago — probably by some of its own members.

AMP’s antagonism toward gene patents and patent exclusivity is ironic and irresponsible. Ironic because employing forced altruism to mandate translational research and clinical labs to relinquish their IP will not only hobble innovation in those very labs (more on that later), but it will dry up the revenue stream at the heart of their R&D and other back-office budgets. Not to mention the chilling effect this kind of activism will have across the industry.

And irresponsible because there exist better ways of making all sides in the debate happy. Why futz with a system that continues to reasonably reward good research and helps lives — and from a group that champions patient rights?

In its haste to enact IP-Free zones and patent exclusivity, AMP, which claims to have 1,600 members, has missed an opportunity to create a noble and equitable format that continues to reward first-movers and allow followers to take advantage of their discoveries, all the while granting innovators the right to do what they will with their inventions. It’s worked this way for generations in other industries; there is no reason why it won’t work in the clinical lab business.

Bait and Switch

Here’s where the current patent row began to germinate. Last week, in a much anticipated draft report, the Secretary's Advisory Committee on Genetics, Health and Society said that while "strong arguments can be made that patents enable innovation," genes and gene-based diagnostics are unique and that "patent-enabled exclusivity primarily results in a narrowing of offerings to patients and physicians."

In the report, James Evans, chair of the SACGHS Task Force on Gene Patents and Licensing, wrote that after a review of dozens of reports, public comments, and case studies, the task force found that patents are not necessary to drive research that "leads to the availability of genetic testing."

He also said patents are not "powerful" incentives for conducting genetics research, disclosing genetic discoveries, or investing in development of genetic tests, but that they limit clinical access to genetic tests.

A few days after the SACGHS report appeared, AMP commended it for “taking a strong stance against business practices that harm patients, restrict innovation and reduce access to life saving tests.” AMP President Jan Nowak called the report “a milestone in our efforts to improve access to genetic tests,” and said “the threat of enforcement from a patent holder” — never mind the threat of government-enforced allowance! — “has created a chilling effect on clinical laboratories making us reluctant to develop new tests that could directly benefit patients.”

First let’s outline why AMP’s issue isn’t really about outlawing gene-based patents. After all, the group is known for extolling the virtues of protecting innovations. In a November 2008 policy statement, AMP concedes that “[m]any disease-associated genes in humans and their pathogens have been identified in recent years, and more will be discovered in the coming decades. Advances in modern genomic technologies and the ability to conduct genome-wide association studies will contribute to this progress and will usher in an era of personalized, predictive, and pre-emptive health care.

“Clinical laboratories in both the public and private sectors translate and develop many of these discoveries into molecular diagnostic assays and seek to make these tests widely available as clinical services for the public good,” AMP says. “In this role, clinical laboratories and laboratory professionals are vital to the translation of scientific discoveries to patient care.”

Indeed, clinical labs “can only develop these important tests when they have access to the broadest base of genomic discoveries” — i.e., patents.

But there’s a hole in AMP’s anti-patent logic: Researchers have been patenting “single genes, genome sequences, and correlations between genetic variations and biological states” (in AMP’s own words) since they were discovered not because of an altruistic impulse to help “the public good” (AMP’s phrase) but because of a need to excel, to profit, and to begin the exercise anew. The size of an average lab’s testing menu attests to the success of this system.

But AMP also serves up a dark side: “Gene patents can serve as a disincentive to innovation in molecular testing because they deny access to a vital baseline of genomic information that cannot be ‘invented around.’ Moreover, threat of enforcement from a patent holder and ensuing litigation costs lead to a chilling effect as clinical laboratories are reluctant to develop new tests that could directly benefit patients.”

“Deny access?” “Threat of enforcement?” “Chilling effect?” Take another look at that testing menu. Does it represent a) an IP environment overrun with patent-enforcement Gestapo, or b) inventors successfully licensing their discoveries?

Coincidentally, AMP said it best in a May 15 press release: “Clinical laboratories cannot develop these important tests unless they have access to the broadest base of genomic discoveries. This access grows more critical as modern technology platforms allow for increasingly sophisticated tests that encompass a greater range and diversity of content from the genome.”

Labs already “have access to the broadest base of genomic discoveries.” They, like any other researcher, patient, customer, or end-user must first negotiate a license to the IP before it can be used — a practice in clinical labs for as long as clinical labs have been around.

This much is true, and has been proven time and again in other industries: Killing the financial incentive to create — outlawing gene patenting — will snuff out innovation in a single stroke in the US and embolden researchers to pursue their discoveries in more liberal parts of the world.

I’m not alone in this boat. In fact, I’m in good company. A particularly “scathing” review — in the words of GenomeWeb Daily News reporter Matt Jones — “came from Brian Stanton, ad hoc adviser to the SACGHS. Stanton, a molecular oncologist who worked in intellectual property and technology transfer policy for the NIH and the US Patent and Trademark Office, said the draft paper was "based on flawed assumptions" and its current recommendations were derived from misinterpreted data and that they were "presented in a biased manner."

Stanton also called the report largely "confused" and "illogical." And said the evidence on which it builds fails to support the recommendations. Also, it over-reaches beyond the assignment with which the committee was initially charged, he said.

"After years of study and effort, the data demonstrates no evidence that intellectual property laws or licensing practices are the cause of general harm, a lack of technology development, or any systemic lack of public access to genetic testing," Stanton wrote.

The SACGHS report “fails to present and represent the input of public comments in a proportional and fair manner" and includes "inconsistent findings and flawed logic," he added.

But I don’t think simple gene patent licensed was ever AMP's principal fight. Because it knows it could never fundamentally alter the patent code (and I think deep down AMP realizes that doing so would hobble innovation), I believe its gripe centers on patent exclusivity, and that its calls to outlaw gene patents was a red herring to get officials to consider nixing patent exclusivity.

According to AMP, “[a] gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene or to greatly limit those who can access the gene through the use of exclusive licensing agreement. As a result, scientific research has been delayed, limited or even shut down due to concerns about gene patents.”

It then cites the poster child for such corporate greed, Myriad Genetics, which has presumably turned the IP rights to its BRCA estate into a comfy chair in which to sit idly as women worldwide succumb to breast cancer.

In the case of the BRCA genes, Myriad’s lab is the only place in the country that performs full sequencing of the genes for diagnostic purposes.

AMP goes on: “Frequently, patent holders and their exclusive licensees are choosing to monopolize molecular testing by restricting other health-care providers and facilities from developing or performing tests covered by these patents and licenses.”

While AMP offers no evidence to support this claim, I can at least point you to a mental image that negates it. Take another look at an average lab’s testing menu. Does it suggest gene-patent hoarders are running amok?

Other life-science industries manage to live with patent exclusivity. When a device manufacturer invents a new implantable defibrillator, it is not obliged to share its patents with its rivals. What investor would bet on a company if the inverse were the norm?