December 18, 2014
December 17, 2014
December 16, 2014
December 15, 2014
Dr. Watson, Genomics and the Law
Since the legal tsunami of court decisions affecting many aspects of life sciences - from patents on Round-UpTM Ready soybeans to "companion diagnostics" - has rolled back out to the sea of summer break, I have found time to reflect on the progression of the life sciences - particularly genomics. My musings were prompted by two recent New York Times' articles - one by Edward Rothstein on an exhibit, "Genomics - Unlocking Life's Code", (Aug. 30, 2013) now at the Smithsonian Institute and another by Amy Harmon, entitled "Golden Rice: Lifesaver?" (Aug. 25, 2013).
My reflections were also triggered by an opportunity that was offered to me a few weeks ago - and that I leapt to take - to go birding with Dr. James Watson, the co-discoverer of the structure of DNA in 1953. Although he is well into his 80's, he had little trouble getting in and out of my SUV and "getting on" the birds with his binoculars. A further coincidence was that, earlier in the year, I had presented a paper on patenting DNA at the Cold Spring Harbor Laboratories, where he is the Emeritus Director. I told him this with some trepidation, since he came out against patenting DNA many years ago.
The point of this story is not to point out the wonders of geriatric medicine, but that it reminded me that all the progress that has been made in genomics-based biotechnology has occurred in the blink of an eye, insofar as human scientific advances go. When Drs. Watson and Crick published on the structure of DNA in 1953, I was unwrapping my first chemistry set. Ten years ago, a human genome was sequenced. If the service was widely available, most people could carry the DNA sequence around with them on a flash drive. All this progress in only about 50 years! If any of you youngsters think that this is a long time, consider that it took 500 years or so from the discovery that the planets revolve around the sun until we could put a man on (just) our moon.
The first article about the genomics exhibit is primarily upbeat, and summarizes some of the advances that have been achieved, or still seem to be achievable, following the successful sequencing of a human genome ten years ago. These include diagnostic tests, like the notorious BRCA 1/2 tests that can predict a propensity to develop certain cancers or other conditions due to mutated genes, such as Down syndrome.
Apart from these ethically troubling tests, do you want a test to tell your medical future when your future maladies may not be curable? The value of a test that will tell an oncologist which of several regimens of chemotherapy will be the most effective against a particular form of cancer seems beyond dispute. Yet, recent decisions from both the Federal Circuit and the Supreme Court have moved the basic patent-eligibility of both of these types of tests onto a legal fault line.
If the courts tell researchers, both in pharma companies and in academia, that it is not worthwhile to even apply for a patent on such inventions, the patent cost/benefit equation will be put to the test. Will the entities that can develop and commercialize such tests continue to do so, or will patients be forced to do their own searches of the medical literature and then go beg the researchers who can dosuch testing to run the relevant tests on them?
The Times' article notes that there are about 4,000 maladies that are due to "single gene defects." Some of these conditions can be readily treated by enzyme replacement therapy, but is your child's one of them? (Think of the plot of "Lorenzo's Oil" relived thousands of times.) Myriad's diagnostic claims were subject to challenge in the courts because one academic researcher said he was prepared to duplicate the tests. Since the Myriad decision, just two companies have said they plan to offer the tests. Assuming that they can actually enter the market, will patients actually reap the benefit of reliable tests and lower costs?
The second Times article did not view the "genetic engineering" of plants in such a positive light. It began by reporting that, recently, protester destroyed test plots of "golden rice" in the Philippines. The protestors were not persuaded that the health benefits of rice genetically-engineered to produce beta-carotene, the source of vitamin A, outweighed the risks to society as a whole. A number of organizations such as Greenpeace have opposed growing and consuming such "Frankenfoods" for years, and have succeeded in having GMO's (genetically modified organisms) such as "Golden Rice" banned in Europe.
Although, by the late 80's, a number of crops could be genetically altered by the introduction of "foreign" DNA, mostly bacterial genes that detoxified herbicides, the field - pun intended - took off commercially in 1996 when patents prosecuted by me and Dr. David Parker issued covering corn plants that had been genetically altered by the introduction of genes that resisted corn rootworm attack and that would survive the application of glyphosate (Round-Up). This resistance to Round-Up permitted the farmers to spray fields of corn with this relatively environmentally safe herbicide that would kill the weeds but spare the resistant corn.
Monsanto and other companies involved in ag biotech went about promoting Round-Up Ready corn and soybeans using stealth sales techniques that focused on the benefits to the farmers of using a less-toxic herbicide - or none at all in the case of "Bt corn" - and increasing their yields. Farmers were willing to pay a premium for that seed. By the time the Supreme Court affirmed the patent-eligibility of plants in 2001, about 65% of all of the corn seed planted in the U.S. was genetically modified. Now almost 100% of all of the corn, soybeans and cotton grown in the U.S. are GMO's.
A few years ago, California voters defeated a referendum resolution that would require the labeling of foods containing (or prepared using?) GMO's but the question was already moot. Corn and products made from corn such as high fructose corn syrup, corn starch and corn gluten meal are ubiquitous in our food chain. Imagine if the California referendum passed and today's grocery shopper enters Cub Foods. Almost all of the processed foods on the shelves would be labeled. In England there are fast food chains that advertise their sandwiches as "GMO free" - but Brits and Europeans can grow all the corn and soybeans they care to consume. About half of the corn grown in the U.S. is used for animal feed; it so happens that we eat much more meat than Europe.
So GMO's conquered the biggest field crops in the U.S. before consumer-advocacy groups got up any steam. Why hasn't "Golden Rice" caught on, particularly in countries in the Near East where rice is a staple in the diet and thousands of children become blind or even die because of vitamin A deficiency? Apart from the clear public health benefit of "Golden Rice", rice farmers would not pay a premium to plant it. "Golden Rice" was developed by a non-profit group and is not patented. Furthermore, its "foreign genes" come from plants naturally high in vitamin A, not from bacteria, and it is known that any proteins produced by the genes do not survive digestion. And the rice is effective, providing enough vitamin A to meet 60% of the daily requirement for a healthy child in one bowl.
I recall the hoary B movie line, "There is some knowledge man was not meant to have," but erring on the side of caution, the mantra of the "green movement" is not enough of a reason to sacrifice the lives that could be saved with a bowl or two of "Golden Rice." Greenpeace should fall back to opposing processed foods that are both costly and formulated using GMOs. Maybe then they could make a case beyond the one it only advances by spreading fear of the unknown which, as I note above, is becoming more "known" every day.
- USPTO Issues New Subject Matter Eligibility Examination Interim Guidelines – Nature-Based Product Guidance
- Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit
- PTO Litigation Center Report – December 16, 2014