Law evolves with growth of biotechnology
May 12, 2008
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”You need the IP lawyers to try to generate market exclusivity,” said David W. Clough, managing partner of Howrey’s Chicago office. His practice focuses on the acquisition and enforcement of intellectual property rights and IP strategies for clients involved in biotechnology. ”It’s very hard to get somebody to invest in the development of a new drug if there won’t be any market exclusivity in the way of patents to protect them from competition, so they can recoup their investments.”
Technology takes off
When industry experts and biotech-related patent lawyers talk about the advent of modern biotechnology, many of them turn back the clock to the mid-1970s, when a new scientific field called recombinant DNA technology took off, and when the first of the biotech companies — such as South San Francisco-based biotech giant Genentech — were born.
”They discovered they could pluck genes out of human cells and put them in other kinds of cells. This technology allowed you to take them out and put them in cells like mini-factories,” McNicholas said. ”You’ve got this whole other group of therapeutics, made by living cells — these factories that produce the proteins we want to make.”
Take Thousand Oaks, Calif.-based Amgen’s recombinant human erythropoietin, or EPO, which hit the market in the late 1980s, becoming one of the biotechnology industry’s first blockbuster medicines.
EPO, a protein found in the human body that stimulates the production of red blood cells, is produced using recombinant DNA technology. The therapeutic is used to treat certain types of anemia, including the anemia associated with renal failure in people undergoing kidney dialysis.
”EPO, and a number of other human proteins used in therapy, are commonly made in hamster cells,” said Borun, who drafted the first of the applications for the numerous patents related to the medicine in the early 1980s.
John J. McDonnell, a founder of McDonnell Boehnen Hulbert & Berghoff who is also considered a pioneer in biotech patent law, was involved in the early litigation over the original patents related to the blockbuster therapeutic.
He said EPO became a classic example of how scientists try to find a human protein that could be genetically engineered to mass-produce as a drug product.
”It turned out that EPO, which is produced in the liver, travels to the bone marrow and stimulates the production of red blood cells,” McDonnell said. ”They finally discovered the gene, the DNA sequence that coded for EPO, and were able to take that DNA sequence, put it in a CHO [Chinese hamster ovary cell] and grow the cell so that it would produce that human protein and it could be used for a drug.”
According to the website of the national Biotechnology Industry Organization, biotechnology is responsible for more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS, and autoimmune disorders. The organization notes that there are more than 400 biotech drug products and vaccines currently in clinical trials that aim to target more than 200 diseases, including various cancers, Alzheimer’s disease, heart disease, diabetes, multiple sclerosis, AIDS, and arthritis.
Lawyers working in the industry said they have seen how traditional pharmaceutical companies are looking to biotechnology to ”refill the pipeline” of new drugs.
”You saw an awakening in the pharmaceutical industry over the years. They wanted to tap into the biotechnology pipeline, to bring those developments in-house,” Clough said. ”We’re seeing a continuing activity with the big pharmaceutical companies acquiring biotechnology companies that have one or more promising products in their pipeline. This is actually supplementing the pipeline of the traditional pharmaceutical companies. It’s been accelerating over the last 10 years or so.”
Scientists-turned-lawyers
About a decade before the 1980 landmark Supreme Court decision involving Chakrabarty’s oil-eating bacteria, Borun was attempting to launch his own career in intellectual property.
In 1969, as a law student at Loyola University Chicago with a bachelor’s degree in biological sciences, he was at first not allowed to sit for the Patent Registration Examination, the separate bar exam administered by the U.S. Patent & Trademark Office to people with adequate scientific or technical backgrounds who want to be licensed to practice before the PTO.
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