Law evolves with growth of biotechnology
May 12, 2008
By Louis Pasteur may have received a patent on his work with yeast — a living organism — back in 1873, but it was Ananda Chakrabarty’s invention of a live, genetically engineered bacterium capable of breaking down crude oil that was at the heart of a 1980 U.S. Supreme Court decision that is said to have opened the door to the business of biotechnology.
Industry experts point to the high court’s ruling in Diamond v. Chakrabarty, which established that genetically engineered life forms are patentable, as the impetus for the commercialization of an evolving technology that generally involves the manipulation of living things to make or change products — such as human therapeutics to treat certain forms of cancer, crops that are resistant to drought, or new forms of fuel.
”It was just a matter of timing and rather interesting technology that made for headlines and heavy-duty investment,” said Michael F. Borun, of counsel to the intellectual property boutique Marshall, Gerstein & Borun. ”A patent is a short-term monopoly, and investors love monopolies. When people saw that there was a space for some exclusivity in this technology, then the money came floating in.”
So did a new niche in the practice area of intellectual property law.
”It’s economics,” said Borun, who is considered a pioneer in biotech patent law. ”Law firms said, ‘There’s money to be made in providing services in this area to clients, but we don’t have anybody with a technical background. Let’s start hiring people with PhDs in molecular biology.”’
Chakrabarty, now a professor of microbiology and genetics at University of Illinois at Chicago, was working as a scientist for General Electric when he came up with the oil-eating bacterium that would be used to clean up oil spills.
Since the high court’s decision holding that the tiny, live creature is patentable subject matter as an article of ”manufacture,” the U.S. Patent & Trademark Office has issued numerous patents on genetically modified microorganisms and other life forms, as well as cells, tissues, and molecules derived from those things — like nucleic acids and proteins. The patents cover such areas as immunology, antibody production, gene therapy, and genetically altered, or transgenic, crops and animals.
The United Nations Convention on Biological Diversity defines biotechnology as: ”Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.”
Many biotechnology inventions serve as the building blocks to potential products that eventually make it into the marketplace. Those results could be a life-saving drug; a pet cat engineered to be hypoallergenic; transgenic plants like one that allows tomatoes to be picked green and ripen thereafter, or soybeans and other crops that are resistant to herbicides; and livestock engineered to produce proteins in their milk.
Headline-grabbing developments talk about cloning animals like prize bulls, or the possibility of one day using stem cells to ”grow” human organs or tissue, or specially engineered microorganisms to aid in the development of biofuel.
The applications of biotechnology tools are wide-reaching.
When Janet M. McNicholas talks about the industry, the biotech patent lawyer who co-chairs the life sciences practice group at Bell, Boyd & Lloyd borrows a motto from the Washington, D.C.-based Biotechnology Industry Organization to point out that biotechnology can work to help ”heal, feed, and fuel” the world.
”What biotechnology does is, it provides solutions,” McNicholas said. ”We’re talking about solutions for problems, whether that problem is that you can’t grow enough corn to feed people, or you have cancer and you need something to get rid of it. There’s some problem that relates to human beings in a really important way — that’s something the technology has the ability to solve.”
IP is crucial
In today’s research-intensive, highly regulated industry of biotechnology — a field steeped in ideas, invention and science — a company’s intellectual property can be its main asset, particularly when the company is getting started.
As such, industry experts stress, the protection of that intellectual property — often in the form of patents — is fundamental to the industry.
Janet M. McNicholas of Bell, Boyd & Lloyd and David W. Clough of Howrey (with Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff back to camera) in a lab of the Department of Biochemistry & Molecular Genetics at the University of Illinois at Chicago’s College of Medicine.
”It’s especially important to the biotechnology industry, because the investments that are necessary to bring a biotech product to market are so huge that unless you have very strong intellectual property protection, the risk is so much higher than with, say, a software company,” said David Miller, president of the Illinois Biotechnology Industry Organization, a local biotech trade group.
For example, it can take up to $1.2 billion and sometimes more than a decade to fully develop a new therapeutic protein — an antibody to treat a disease like cancer — and to bring it through U.S. Food & Drug Administration approvals and into the marketplace, said McNicholas, who is also a former molecular biologist.
”These things — the products — come from living things. Those living things — whether it’s a living plant or a living cell — that’s not the same as some kind of cheap plastic product from China,” McNicholas said. ”’These are very complicated systems, and they require a great deal of research and development, and they’re regulated.”
That’s where lawyers with a mix of expertise in the biological sciences and intellectual property law enter the picture.
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