Micheline Gravelle has access to some of the best science in the world. She’s privy to the newest ideas and discoveries in biotechnology and literally operates at the cutting-edge of science. No, she doesn’t work for a secret government intelligence agency. Gravelle is a patent agent and partner at Bereskin & Parr, an intellectual property law firm based in Toronto.
Gravelle completed her masters degree in immunology in the laboratory of Atsuo Ochi at the Samuel Lunenfeld institute in Toronto, investigating cytotoxic CD4+ T cells and the targeting of B cell lymphoma using antibody conjugates.
At the time, Gravelle wanted to pursue a PhD, but felt herself drawn to many different research areas and was reluctant to focus on a single topic. However, she also knew that her ideal career was one where she could use her background and training in science and also be able to interact more directly with people.
When Gravelle graduated, many law firms were looking for individuals with a background in science. Biotechnology as a field was beginning to grow rapidly, and most patent lawyers at the time were engineers, so law firms were particularly interested in individuals with expertise in the life sciences. When a family friend proffered an opening at a law firm, Gravelle jumped at the opportunity.
During this time, she wrote the patent agent exam, a requisite to becoming a patent agent. With a lot of talent and a bit of luck, she passed the grueling four day exam on her first try (the pass rate for the exam was 20-25%). Gravelle moved to another firm before starting with her current firm in 1996. Today, she is head of the Biotechnology and Pharmacy practice group at Bereskin & Parr.
As a patent agent, Gravelle handles the patent application process and advises researchers and companies whether their discoveries can be patented. She also helps companies or other firms extend their existing patents to Canada. “Good science isn’t always patentable,” says Gravelle, but she does appreciate being able to hear about the latest innovations and discoveries in science.
[pullquote]“Good science isn’t always patentable”[/pullquote]
Patents are a set of exclusive rights given by a government to an inventor for a limit period of time (20 years in Canada, US, and Europe), in exchange for the public disclosure of the invention. Inventions must be novel, non-obvious, and have practical applications to be patented. Inventions cannot also have been previously disclosed – publication, for example, prevents a patent from being granted in Europe and many other places in the world. In Canada and the US, a one-year grace period is available for time between publication and patent application filing date.
Patents can function as incentives for research and development and promote the public disclosure of new inventions. However, patents can also drive up the cost of a product and substantial time and effort can be associated with obtaining and defending a patent. Obtaining a patent can take several years, and involves debate with patent examiners (and potentially competitors) who challenge the patent on both scientific and legal terms on why a discovery is novel.
As the number of biotechnology patents increase and the market becomes crowded, it can also be difficult to establish novelty for a new discovery. With advances in research, the limits of what can or cannot be patented also become difficult to define.
Gravelle describes the case of Myriad Genetics, a US biotechnology company that holds patents on the human BRCA1 and BRCA2 breast and ovarian cancer susceptibility genes. The patents on these genes mean that only Myriad and the companies or institutions it licenses can test for BRCA1/2 mutations. These patents are currently being challenged and the case is before the US Supreme court as of mid-April 2013.Many researchers and companies are anxiously watching the case in the US, as there are thousands of patents on human genes that have been granted by the US Patent and Trademark Office over the last 30 years. The decision by the US Supreme Court could support further patenting of human genes or potentially expose existing gene patents to litigation.
As a patent agent, Gravelle doesn’t handle any litigation if a previously granted patent is challenged in court. Instead, the task is handed off to a separate team of patent lawyers at the firm. One of the few regrets that Gravelle has is not finishing a PhD. However, she also believes the timing for the position at her first law firm was fortuitous, and the opportunity may not have lasted had she waited another year or two to complete a doctoral degree.
For those interesting in pursuing a path in patent law, Gravelle recommends completing law school along with a PhD. For many law firms, these degrees are hugely beneficial and in many ways a requisite for entry. In fact, many of the job applications that she receives come from individuals who hold both doctoral and law degrees. To succeed as a patent agent, she says, requires one to be time-efficient and “a very practical thinker. You can’t get bogged down in the details.”
Myriad Genetics and Gene Patents
In 2001, Myriad issued a cease and desist letter to Canadian provincial governments, demanding that all genetic testing for BRCA1/2 mutations be done through Myriad. At the time, Myriad’s diagnostic test cost approximately $3,500, 4 times what it would cost most provinces to perform the test locally. Some provinces, including Ontario and Alberta, ignored the patent and continued testing, while British Columbia temporarily stopped offering the test.
Myriad’s patents were recently challenged and upheld in Australia, because isolation of the gene was ruled to require expertise similar to the manufacturing of a product. The core of the argument is whether a naturally occurring material – in this case a human genetic sequence – can be patented. A separate case is currently before the US Supreme Court, with arguments to be heard mid-April 2013.
- Gene patents provide incentives for companies to develop new genetic tests. Myriad spent roughly $500 million to bring the BRCA1/2 test to market.
- Patents however, also drive up the costs of diagnostic tests, an expense passed on to health care providers and ultimately taxpayers.
- Regardless of the US Supreme Court ruling, the generation of recombinant DNA will likely continue to be patentable.
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