Looking back on decades of industry change




In the ever-changing life sciences industry, it is rare to find professionals who have seen the dramatic shifts within the industry over the last few decades. Both Tom Ciotti and Kate Murashige have been heavily involved in patent law for nearly five decades and are familiar with the swings the industry has seen both from a legal and a technological perspective. LMG Life Sciences Head Writer Phillip Bausk spoke with Ciotti and Murashige about their experiences working in life sciences.

Q: What was it like when you started within the industry?

Kate: My timing was very good. I started in patent law in 1980, and that was at the inception of companies like Genentech and others. There weren't many other people practicing and doing the work these companies needed to be done. Tom was instrumental in getting my career off the ground. I got into patent law because Syntex, which was a small molecule company that is now no longer in existence, needed patent attorneys. They couldn't get anyone from the East coast, so they took people like me without patent experience.

Tom: I started my career in patent law working summers, and I was admitted to practice in front of US Patent & Trademark Office in 1963, followed by the California State Bar in 1965. I started off by doing organic chemistry work for Chevron. One of the projects I worked on involved a license from Stanford, which I wrote–the first IP license that Stanford ever issued. As a result, I started to do patent work for them in the late 1960s. I was working in-house for a company, so I was moonlighting for Stanford in the medical school, and through the people at Stanford I was introduced to the full spectrum of biotech work and made a lot of contacts.

I was working for a medium size Virginia-based firm and tried to get them to hire Kate, however, they were very chauvinistic and didn't want to hire a woman. We had talked over the years about practicing together, so I called Kate up, and we shook hands, started our own firm, and the rest is history.

Kate: Thanks to Tom we had plenty of work to do in the industry.

Tom: We opened our firm in October 1983, in Menlo Park, California, and were profitable by the end of the year. At the end of 1986, we were approached by a head hunter from the firm of Irell & Manella. They sent this fantastic lawyer named Ed Kaufman over; it was almost impossible to say no to this guy.

Kate: He was very charming and there were all kinds of wining and dining. It was really just amazing.

Tom: We decided to join, and we talked a lot about the future of where IP law was going. We joined them in March 1987, and were with them for about four years. In 1991, they closed up their northern California office, and we didn't really want to go down to Los Angeles to work, which was an option with them. We were left deciding what we wanted to do, where we wanted to go, and ended up picking Morrison & Foerster.

Q: How has the industry evolved from a product standpoint?

Kate: I think the dust is settling and with respect to the practice, there is a lot more competition because people have caught on that this is an interesting and profitable field. There are still startups, but what happens to these companies is that initially they have all kinds of ideas and patent portfolios, and eventually they have to focus on a product. If they do that and succeed they generally get acquired by a bigger company. If they don't succeed, they go out of business.

Tom: In the beginning, you have to remember that the universities controlled a lot of the materials in biotechnology. They had all of the cell lines and access to patients for testing. Large pharma mostly stayed out of the biotech business. In this area, one of the premiere companies was Genentech, which was started based off technology out of both University of California and Stanford. There were sort of three areas that people were working on; investment bankers referred to them as the good the bad and the ugly: good were diagnostics, bad were therapeutics, and ugly was agriculture. Before biotech came on the scene, you had no way of mass producing human molecules that had a lot of biological significance in therapeutics. Interferon was one of the first molecules expressed.

Kate: What strikes me as really different is that everyone at that point, was producing recombinantly these biological molecules that you couldn't otherwise mass produce. It was doable, though it took a lot of creativity and work. This was especially important in providing a way to produce monoclonal antibodies in quantity, and many are currently being used as therapeutics. I think that now nobody really knows what the next big thing is. People are looking at signaling pathways, personalized medicine–there is no obvious conclusion, nothing so obviously achievable.

Tom: The targets were pretty obvious, but it was hard to find them. It was sort of like a race and everybody else folded.

Kate: I think there is a lot less predictability. People don't have as much of a defined goal.

Q: What about changes with regard to legal proceedings?

Tom: Applications would get held up during interference proceedings and they wouldn't issue anything until after the interference proceedings.

Kate: There aren't that many interferences anymore. Because interferences were being used really to shoot down somebody else's patents, people have turned to re-exams. It will be a while for last year's Leahy-Smith America Invents Act to make a big change. There are a lot of things that don't apply until the first to invent rule comes into play. There are post-grant procedures that pretty much mimic European opposition. There is a lot of talk about how much is going to change. I am not sure if it will so much from a day to day standpoint. What will change is when all of these procedures are available; there will be more involvement with litigation types as some of these procedures will appear like litigation.

Tom: First to file is not alien to us because the rest of the world has had it forever. When we first came to Morrison & Foerster, one of the goals of the firm was to increase its IP Litigation practice. The firm had done a little bit in the electronic IP area, but they hadn't done a lot of patent litigation, and they certainly hadn't done anything in life sciences. It was through us and our contacts that the firm started to do patent litigation in the field. I would estimate that half of the litigators in the practice are working on IP matters.

Q: What is the most interesting shift you have seen in the industry?

Kate: I would say it's the signaling pathways. There are all of these signaling pathways with the way molecules interact with cells and a cascade of interactions with various components of the cell to make it do one thing or the other.

Tom: The science and chemistry of life is extremely complex. Things like cancer, for example, are not just caused by one thing, and sorting all of the causes is really challenging. The same is true with cognitive diseases.

We haven't mentioned yet the large role in the industry of developing tools for scientists. DNA sequencing technology has come a long way. There are certain things that scientists can do now in a couple of days that took them years to do previously.

Kate: There is certainly a lot more variety of invention today, and a lot more competition in the practice now.

Tom Ciotti Kate Murashige




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