By Kevin E. Noonan --
The Internet over the past decade has given rise to a wide variety of "alternative media" outlets, including for example Slate, The Drudge Report, The Huffington Post, and arguably blogs like this one. Even conventional news outlets like The New York Times, The Washington Post, and The Wall Street Journal have exclusively on-line content. Despite the differences between these disparate sources, including writing by some non-traditional "journalists," news outlets of all stripes have many things in common. Unfortunately one of these is an uninformed antipathy to biotechnology, particularly with regard to gene patenting.
This similarity is evidenced most recently in The Huffington Post, in a piece entitled "Gene Patenting Produces Profits, Not Cures." The author, Harriet A. Washington (who also authored Deadly Monopolies; more on that later) writes that Myriad Genetics "predictably" appealed Judge Robert Sweet's decision invalidating fifteen claims in seven patents challenged by several breast cancer patients, medical associations, and researchers (and supported by the ACLU and the Public Patent Foundation). The piece is replete with misstatements concerning the scope of rights conferred by gene patents, such as that Biogen controls "your kidney's essential KIM gene" as well as a list of other genes patented by the University of California and other patent holders. Ms. Washington boldly asserts that the "coalition" challenging gene patents in the Myriad case may have too narrow an agenda, and proposes (conveniently, since her argument provides a précis of her "forthcoming book") that all "life patents" should be banned. These include "the more than 500,000 genes that control the most basic processes of human life," a stunning statement in view of the reality that there are only about 30,000-40,000 genes in the human genome. Setting her sights even higher than genes, she believes that patents on "bacteria, viruses, biologicals such as 'artificial blood', cell lines, tissues, pharmaceuticals, and even on medically important plants and animals such as Harvard's patented cancer-prone 'oncomouse'" should be banned. Why? Because "[t]he $60 billion pharmaceutical industry became the most profitable industry on the planet by exploiting its plethora of patents."
She sets forth a generally correct history of the development of the biotechnology industry. She mentions the Diamond v. Chakrabarty decision, and passage of the Bayh-Dole Act that encouraged universities to protect their inventions (instead of letting them fall into the public domain where they could be exploited by corporations, including foreign corporations, with no compensation to the university or its researchers). She also discusses the rise in university patenting, from about 260 patents/year prior to Bayh-Dole to more than 3,000 patents/year today. She also notes that "by 1991 [universities] had gleaned $218 million in royalties" (an amount certainly much higher today).
Where she begins to show her naïveté about how technology its transferred between academia and pharmaceutical companies is when she says that "corporations receive valuable, ready-made patents on medications, biologicals, genes, devices, plants and animal hybrids," which suggests that the technology transferred is ready to be commercially exploited solely as the result of federal grant support and "university brainpower." While necessary, these factors are woefully insufficient, at least because the FDA requires extensive safety and efficacy studies before any pharmaceutical comes on the market (protection it is unlikely Ms. Washington opposes).
Her argument seems to be that with all the patents and all the research, the public has received less than they were promised. She cites in support of this proposition that "[b]y 2003, North American university researchers had started 374 companies and academic institutions had completed 4,516 licensing arrangements earning them more than $1.3 billion" and that "[b]y 2006, university technology transfer offices had generated at least $45 billion, largely from licensing fees." The result, she maintains, is that universities have become research "satellites" rather than independent entities. This charge is, ironically, belied by the statistics on licensing, which illustrate how universities, due to their patent rights, are in the position to grant licenses to those companies committed to commercializing their inventions. Indeed, most such licenses have commercialization milestones and other provisions that, for example, change an exclusive license to a non-exclusive one (that can be licensed to another company) should the performance milestones not be met.
She repeats some oft-told tales, such as the purported pernicious effects of Chiron's hepatitis C virus test, and the company's failure to produce better treatment despite patents on isolated viral genes. She uses Chiron's lawsuit against a commercial infringer to allege that there was a "chilling effect on researchers who wish to work on better HCV treatments," but provides no evidence that Chiron has sued any basic (non-commercial) researcher working on HCV biology. This is similar to allegations in the Myriad suit that the company was inhibiting basic research, despite the >8,000 basic research papers easily found in PubMed and other databases.
Ms. Washington raises some real limitations to the Western medical research model, including that diseases prevalent in the undeveloped world (such as trypanosmiasis) have not been adequately addressed, and the inefficiencies in business models that require "blockbuster" drug status to support the incredible costs ($800 million - $1.2 billion) of bringing a drug to market. And she mentions John Moore's hairy cell leukemia, Henrietta Lack's vulval adenocarcinoma (HeLa) cells, and Canavan's disease patient samples as examples of corporate exploitation. On the contrary, all of these incidents occurred in a university setting, and the HeLa example occurred in the same time period that saw Jonas Salk perform experiments on his polio vaccine with retarded children from a nearby sanitorium, with precious little informed (or parental) consent.
What Ms. Washington refuses to acknowledge (because it doesn't support her argument) is the real benefits (or "cures") that biotechnology has provided over the past 30 years. Nowhere in her piece is there anything about the thousands (millions?) of heart attack patients whose lives have been saved by recombinant tPA (Genentech), or the thousands (millions?) of kidney disease patients leading relatively normal lives due to recombinant EPO (Amgen), or the thousands (millions?) of breast cancer patients treated with Herceptin® (Genentech), or colon cancer patients treated with Avastin® (Genentech) or macular degeneration patients whose eyesight has improved using Lucentis® (Genentech), not to mention the hundreds of other biotechnological drugs on the market or in development. No, these triumphs don't exist in the world Ms. Washington describes, which must make it easier for her to say:
Some argue that gene patents are necessary to generate the profits essential to funding the medical cures. But as the cases of breast cancer, hepatitis C and hemochromatosis illustrate, genes are more commonly used for faster, easier routes to profit, such as marketing tests, selling licenses and suing those patent-infringers who step on the corporation's biomedical toes.
The biotechnology industry is not without its inefficiencies, but failing to acknowledge the benefits along with the deficiencies makes it easier to set forth the portrayal contained in Ms. Washington's article. But doing so fails to describe "the rest of the story," and does a disservice to anyone wanting to understand the role of both universities and patenting in the biotechnology industry.
Source
Also See: Gene Patenting Produces Profits, Not Cures
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