Thursday, January 21, 2010

Should a company be allowed to hold a monopoly through a patent on crucial human genes?

Listening to On Point with Tom Ashbrook this morning, I heard a well-balanced, informative, and ethically (and more) challenging discussion about patents on human genes (audio available by 3 p.m. ET today) (you should go listen). While this is, in fact, a broader discussion, Ashbrook and his guests eloquently debated specifically the court case revolving around BRCA1 and BRCA 2 -- the genes for ovarian and breast cancer, whose patents are held by a single company, Myriad.

First, a bit of background

-- patents historically are limited to things man invents, not things man discovers. For example, as per the show, one cannot patent gravity, E=MC2, coal, or plants.

-- however, farm corporations have been known to patent plant genes for food and other crops. The sidenote to this is that they actually hold the patent to genetically modified plant genes, not the natural one.

-- Myriad holds the patent to both BRCA 1 and BRCA 2 as they happen naturally, in the human body. They have not genetically altered this.

-- the ACLU and other plaintiffs are suing Myriad to release the patent. The court case has now been delayed until February 2, but the plaintiffs have already stated an intent to use this case as precedent to release other gene patents, some of which are held by corporations, others by individuals and even universities.

A few articles that might be of interest to you as you research to form an opinion (and please do use your Google PhD to research above and beyond this):

Fact Sheet -- BRCA: Genes and Patents (note: published by ACLU, but very useful breakdown of the particulars)

Insider article: Can ACLU Expect to Win Its BRCA Gene Patenting Case Before it Even Gets to Trial?

Associated Content article: Myriad's Patent of BRCA Gene is Contested by the ACLU in Court

Argument A (presented by Hans Sauer, Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization, known as BIO) is that discovering a gene, creating a screening test for it, and working within it has cost over $200 million dollars, and will cost over a billion across 10 years. The revenue made from the patent creates venture capital for additional research. Holding a patent is a motivation to discover and use.

Argument B (PDF here) (presented by Chris Hansen, Senior National Staff Counsel at the American Civil Liberties Union) states that the patents stifles competition, creates a monopoly on price (held at high cost of $3000, usually not covered for women), prohibits improvement on the testing process, limits women on ability to get adequate information when facing a major medial and/or surgical decision (Myriad will not allow any lab other than their own to test, and therefore there is no second opinion, for example), and infringes on the legal allowance for patents.

In general, the argument sticks to two sides: patent or no patent. However, during discussion other experts offered up middle-ground solutions that involve patent pools and non-exclusivity agreements.

What do you think -- should gene patenting be allowed? And if so, with what protections for us, the humans who carry the genes?

4 comments:

fpaynter said...

Patenting genes is like patenting water. Certain "discoveries" in nature provide information to form knowledge. From knowledge and skills new things can be derived, and of course it should be fair to protect the property that derives from applying knowledge. Genome maps should all be in the public domain, no matter what the species.

Sitting Still said...

Apologies in advance if this is too long.

As a genetic counselor, I've been listening to debates on both sides of this issue for awhile. It's not new, though the lawsuit is bringing more attention to it.

It's hard for me to come down strongly on one side or the other on this.

On one hand, the argument against patenting something "natural" seems logical. Who owns a gene? Not a company, right? But, the argument starts to fall apart when we stop treating genetic testing as exceptional and look at it in the context of general biotech/pharmaceutical practices. Just like new drugs, genetic tests take years to develop, validate, and bring to market. Just like new drugs, some people have insurance coverage for them (or money to pay out of pocket) while others don't. And just like new drugs, genetic tests are marketed to healthcare providers, which requires things like marketing campaigns and salespeople. You can say that sales are bad, but when I look at Myriad's business practices, I think they've actually done a lot to educate providers and patients and increase access to genetic testing for hereditary breast and ovarian cancer on the whole.

On the other hand, it has been frustrating to me in clinical practice not to be able to get patients the testing they want and need because of the expense of testing and the lack of healthcare coverage for these tests.

Genetic tests are often expensive, and that's true whether they're patented or not. It can also be determine whether a test is, in fact, appropriate for a patient because doctors with good intentions order the wrong test for the wrong patient a lot (and waste valuable healthcare dollars doing so.) As a result, insurance companies and government-sponsored insurance will often just say, "We don't cover that" rather than try to manage, for example, a preauthorization program that judges the value of the test based on the patient's circumstances, like they do with other things like surgery, medications, and other services.

I'll confess to being a liberal who generally sides with personal liberties (and the ACLU). But on this issue, I wonder if the argument over patents is relatively minor. The larger issue, to me, is how we educate the healthcare providers and the public at large about the benefits and limitations of genetic testing, and how we help insurers make policies around this testing so that they can make reasoned decisions about coverage, rather than just saying no.

Genetics is rapidly changing from a field that impacts a small number of patients with rare diseases (even BRCA mutations account for only 5-10% of all breast and ovarian cancer) to one that applies to all of us in the diagnosis and treatment of more common conditions. We need to sort these issues out -- and frankly, the field is evolving much faster than the policy created around it.

The Secretary's Advisory Committee on Genetic Testing (SACGT) of the NIH has been working on a report of gene patenting and access issues for over 3 years, and they meet soon (early February). The expectation is that this meeting will see the approval of a report on just this issue. I'll be very interested to see what their research has produced.

Score One Art Gallery said...

I think when one decides to patent something it should be because they created it, modified it or something along those lines. Taking something that occurs naturally, like another comment mentioned, is like trying to patent water, or air. They didn't create these things. How can they own them?

Ed T. said...

I think the question goes beyond whether or not a company (I presume you mean "Corporation") should be allowed to patent/hold a patent on genes (human or otherwise.)

I am actually against *anyone* being able to hold such a patent (unless the holder is God, or "The Universe", or whatever) on genes discovered. For genes that don't exist in nature, but are creations, the patent might be applicable to the modification (and almost certainly to the method used to create the modified gene), but even there I have strong ethical issues around someone "owning" as it were the gene itself.

However, I don't see any reason to treat "companies" (which are, after all, organized groups of people) any different in this regard than I would treat an individual (whether acting as a "natural human" or as an "incorporated entity for the purposes of doing business" (and protecting his/her personal assets from lawsuits).)

~EdT.