SARS and the Patent Race:
By PETER K. YU
|Thursday, May. 29, 2003|
Scientists and doctors are engaging in a friendly race to search for treatments for Severe Acute Respiratory Syndrome (SARS). Meanwhile, their lawyers have been engaging in a totally different race.
In the past month, the Centers for Disease Control and Prevention in Atlanta, the British Columbia Cancer Agency, and the University of Hong Kong have been battling to patent the coronavirus that is believed to cause SARS.
Although no institution can currently claim a monopoly on the treatments for the disease, the patenting race has sparked major concern in the public health arena. If an individual or an individual company could indeed obtain such a monopoly, the results could be disastrous.
SARS and Gene Patents
Under U.S. law, a patent can be granted to "anything under the sun that is made by the hand of man." One can claim a patent on a device, a mechanical process, a computer program, or even a genetically engineered organism.
In the beginning, the U.S. Patent and Trademark Office was fairly conservative in granting patents on bio-engineered organisms. That trend changed, however, in reaction to the 1980 landmark Supreme Court decision of Diamond v. Chakrabarty. In that case, the Court held that a bacterium genetically engineered to consume oil spills was patentable.
Since Chakrabarty, patents have been granted on a wide variety of bio-engineered products, including polyploid Pacific oysters and the famous Harvard mouse. The U.S. biotechnology industry has flourished, and the U.S. has become a world leader in genetic research.
Today, naturally occurring life forms remain ineligible for patent protection (since they are not inventions "made by the hand of man"). However, one could arguably patent any gene or life form that has been modified by biotechnology, including genetic engineering.
The Danger of a Patent System That Extends Too Much Protection
Apparently, some patent protection is needed to generate economic incentives for companies to engage in research and development, which is costly and time-consuming. However, the patent system must strike the right balance between the protection of private inventions and the public interest. If it fails to do so, it may stifle - rather than spur - the development of valuable scientific and medical research.
In recent years, commentators have expressed concern about "biopiracy" - which occurs when patents are granted for naturally occurring products and indigenous practices that have existed for many centuries. In theory, these products and practices should be exempt from patent protection, for they are neither novel nor inventive. In practice, however, patents may be granted, because these products and practices are largely unknown to the general public.
Commentators have also discussed at length the potential chilling effect created by overprotection of patent rights. After all, the unclear status of patent ownership and the potential liability of patent infringement might frighten away risk-averse investors, who might prefer to spend their time, money, and resources elsewhere.
Even worse - and more fundamentally - patents, to some extent, have become an end in themselves, rather than a means to further a larger constitutional goal - that of promoting "the Progress of . . . useful Arts." Instead of developing their own products, some patent holders seek to use patents primarily to preempt others' research efforts and to profit from such preemption. They apply for a patent not because they want to develop a product, but because they want to be "bought out" by someone who has that goal.
Small wonder the Centers for Disease Control and Prevention and the British Columbia Cancer Agency have emphasized their need to patent the SARS virus so that the scientific and medical community can have open access to the virus for research and other purposes.
The Complex Issues in the Race to Patent SARS
Although the patent race is heated, there likely will not be a clear winner - or there might be many winners. There are several reasons.
Under U.S. law, a patent can be granted on a specific part of the SARS virus or on "improvements" of what has already been discovered. Because the virus mutates from one form to another, the patent applicant might claim rights in only a specific mutation of the virus, rather than its original form or its other variants.
While the U.S. system awards patents to those who are the first to invent, the European system awards patents to those who are the first to file the application. Because of these differences, the U.S. and European patent holders theoretically could be different.
Moreover, the patent application might be complicated by the strong resemblances between the SARS virus and the HIV/AIDS virus, and between treatments for SARS and treatments for the common cold - as recent reports have suggested.
To obtain a patent, the applicant must demonstrate that his or her invention is "novel" and distinguishable from the "prior art," materials and inventions that exist before the patent application. If the resemblances are as close as the reports have suggested, the applicant might have difficulty convincing the U.S. Patent and Trademark Office why the "invention" warrants patent protection.
In sum, there will be a lot of difficult, yet intriguing legal issues relating to SARS patents. It will probably take at least a few years before all these issues can be resolved for good - perhaps through litigation. Of course, this depends on whether the identified strain of the coronavirus actually causes SARS!
Lessons from the HIV/AIDS Crisis Should Inform Our Approach to SARS Research
Scientists and doctors have pointed out similarities between how the SARS virus operates and how the HIV/AIDS virus operates. But these similarities are not the only relevant parallels here. The HIV/AIDS crisis can also teach us valuable lessons on our approach to SARS-related research.
First, like a person infected with the HIV/AIDS virus, a person infected with SARS might not initially show any symptoms. As a result, testing, screening, and education will be critical to the prevention and control of the disease, just as it has been with HIV/AIDS.
Thus, it is very important that we maintain open access to testing and screening for SARS. If a patent holder could prevent others from testing and screening without its authorization (and payment of royalties), the results could be disastrous. After all, as recent incidents have shown, SARS can easily spread from one country to another.
Second, as with the race to patent the HIV/AIDS virus, the race to patent the SARS virus could jeopardize valuable scientific and medical research. One might recall the dispute between France and the United States over who discovered the AIDS virus, and who owned the commercial rights to a blood test that emerged from this research. Fortunately, a 1987 agreement between President Ronald Reagan and French Prime Minister Jacques Chirac split the patent rights and donated the royalties to AIDS research.
Were it not for this agreement, companies who produce diagnostic products might remain confused about patent issues relating to their products, and thus reluctant to invest in tests that help diagnose HIV/AIDS. To avoid repeating this type of problem with respect to SARS, patent rights should be settled as soon as possible.
Finally, HIV/AIDS drugs have created serious tension between developed and less developed countries. SARS has not yet reached the same level as the HIV/AIDS pandemic, and it might never be as widespread. Still, if it remains a recurring and potentially lethal disease, SARS drugs will remain a major concern, and a reasonable fear for the future. What if SARS drugs are as unaffordable as AIDS drugs? Will such drugs be inaccessible in less developed countries?
Commentators have already explained in detail why the patent system may have been inadequate to deal with the HIV/AIDS crisis. When it comes to SARS, we should try not to repeat mistakes that may have been made in our approach to HIV/AIDS. Once patents are granted, they last for a long period of time. If we do not pay attention now, we might find ourselves in an undesirable situation that cannot be reversed.
In sum, the HIV/AIDS crisis has taught us many valuable lessons. Whether we can prevent a SARS crisis will depend on whether we have fully learned these lessons.