SARS spurs race for a cure -- and for patents

The coronavirus that causes the respiratory disease was discovered and sequenced in record time because of unprecedented international collaboration. Now everyone is staking a claim.

By Victoria Stagg Elliott, AMNews staff. May 26, 2003.

Who owns it?

That's quickly becoming a point of interest now that the genetic makeup for severe acute respiratory syndrome has been sequenced -- raising questions that could ultimately affect the next advances in the development of SARS diagnostic and treatment tools. The answers will also set the precedent for the handling of genetic information of future emerging infections.

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SARS history

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For now, at least two government agencies have applied for a U.S. patent on the coronavirus that causes SARS, and for its gene sequence. The U.S. Centers for Disease Control and Prevention and Canada's British Columbia Cancer Agency have both publicly acknowledged that they have taken such action. And, according to several news reports, many more public and private entities may be attempting to secure patents on the virus or its various parts. The full list will not be available until at least 18 months after application, in accordance with U.S. Patent and Trademark Office policies.

The flurry of claim staking has raised again the long-hovering uncertainties that surround patenting of organisms and genes, and resurrected debate about whether such patents hinder or help scientific progress.

Patent experts say that the process allows information to be shared freely because a patent protects inventors' rights to profit from discovery. Some scientists, however, say the process is frustrating.

"Once something becomes patented, it's much harder to distribute it readily," said David Sanders, PhD, associate professor of biological sciences at Purdue University in West Lafayette, Ind. "In the course of my career, the difficulty of rapidly obtaining reagents has increased tremendously, and that's a real problem."

2 governments have applied for a U.S. patent on the coronavirus that causes SARS.

In the case of organism and gene-sequence patenting, most of the scientific concerns are focused on the use of the patent, rather than the patent itself. According to the AMA's Council on Scientific Affairs, patents are acceptable if the applicant could demonstrate understanding of its use. Licensing, though, should not impede scientific progress.

"The basic concept is that it's OK," said Mohamed Khan, MD, PhD, a member of the council. "The key with whomever gets the patent on SARS is to make sure that they don't use that to restrict access to diagnostic tests or treatment."

Both the CDC and the Canadian agency have stated that their efforts are preemptive. They want to ensure that the virus and the sequence remain in the public domain, and they don't want to take the chance that a private company may attempt to control the licensing of the patent in a way that impedes research. Both sequences were published simultaneously in Science early in May.

"Depending on who held the patent, it could potentially lock out competitors from being able to participate in the patent, or products of that patent," said CDC Director Julie Gerberding, MD, MPH. "Our decision was that first of all we would try to make as much information available in the public domain as we possibly could. And then secondly, if there is going to be a patent issued that we would apply for it, so that we could ensure that open access as we went forward."

The CDC has already completed licensing agreements with 17 of the 32 entities that have requested them and is working on the rest.

Canada's BCCA is also sending out samples to nearly all interested investigators. "We are shipping out clones to just about everybody who has been asking," said Samuel Abraham, PhD, director for the agency's technology development office. "In the past, patents have been used to confer monopolies. We're doing just the opposite."

Discovery and collaboration

Patenting viruses is not new. Patents have been granted for more than 20 years, and researchers who hold patents on viruses say the move is vital to protect their work or even to allow it to proceed.

"It's a moral dilemma," said Charles Grose, MD, professor of pediatrics at the University of Iowa in Iowa City, who recently received a patent on a mutant chicken pox virus that he discovered. "If you don't patent it, the next person who finds it probably will, and then you're in the odd situation of having to receive permission to do experiments on something you discovered."

A patent protects an inventor's right to profit from the discovery.

But there is some worry that significant international collaboration that resulted in the SARS virus being discovered and sequenced in a matter of months may not be repeated if, after so effectively joining forces, all agencies seek to protect their own interests.

"The World Health Organization is very concerned that anything to do with potential patenting should not lead to any drop-off in the unprecedented solidarity amongst researchers on the SARS investigation, including the development of diagnostic tests, drugs for treatment and a vaccine," said Melinda Henry, a WHO spokeswoman.

Patent law experts say that fights after this kind of collaboration are common. They mention the battles over HIV and the hepatitis C virus and their gene sequences as the most notable. They also say that in their experience, rival patent filings do not impede future collaborations. The parties will probably come to some kind of amicable agreement. There is also a significant chance that the actual applications may not conflict with each other.

"Just because there are many patent applications filed, does not mean that the claims are identical or overlapping," said Teresa Stanek Rea, RPh, a biotechnology law specialist and partner in the Alexandria, Va., intellectual property firm of Burns, Doane, Swecker & Mathis LLP.

But while there is still some discomfort with the concept of patenting organisms and concern about how they are used, patent law experts are quick to point out that applying for a patent is easy. Anyone can do it, but not everyone is successful. These patents won't be awarded any time soon. The average interval for a biologic from application to decision by the patent office is two to three years. Some take as long as a decade if several entities are applying for the same thing.

And enforcing a patent is another matter entirely.

"Even if these things are legitimate, they're not going to protect anything. Virtually everything is patentable, but not all of them are enforceable," said Jeffrey Oster, PhD, senior vice president of intellectual property at CombiMatrix Corp., a life science company based in Mukilteo, Wash., that has filed patents for molecules that may turn out to be therapeutic against infection with the virus.

ADDITIONAL INFORMATION:

SARS history

November 2002: An outbreak of a mysterious respiratory illness occurs in Guangdong Province, China, making hundreds seriously ill and killing dozens.

Mid-February 2003: Virus spreads to Vietnam and Hong Kong; international travel blamed.

Mid-March: Virus spreads to Singapore and Canada.

March 15: A Singaporean doctor travels through New York on his way to Germany, becoming ill en route; he is diagnosed with SARS in Frankfurt.

March 17: World Health Organization facilitates the collaboration of 11 laboratories in 10 countries to identify the cause of SARS.

March 24: Centers for Disease Control and Prevention announces that a coronavirus strain causes SARS.

March 29: Dr. Carlo Urbani, a WHO officer who treated the earliest cases in Hanoi, dies of SARS.

May 1: CDC and the British Columbia Cancer Agency in Canada publish near-identical sequences of the SARS virus in Science.

May 8: SARS tallies more than 7,000 cases in at least 30 countries; kills at least 160.

Sources: CDC, WHO

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