Law360 Q&A With Knobbe Martens' Mark Benedict
Law360, New York (July 27, 2012, 1:42 PM ET) -- Mark Benedict is a partner in the Orange County, Calif., office of Knobbe Martens Olson & Bear LLP. Since joining Knobbe Martens in 1997, he has specialized in patent prosecution, strategic patent portfolio management, infringement and validity analyses, and IP due diligence and licensing for pharmaceutical, biotech and medical device clients. Before law school, Benedict obtained a Ph.D. in biology and conducted biomedical research in endocrinology and aging as a post-doctoral fellow and later as a research faculty member of SUNY Upstate Medical Center.
Q: What is the most challenging case you have worked on and what made it challenging?
A: All projects are challenging because I set a high performance bar for myself and my team. One matter that I recall as being unusually challenging was an interview at the U.S. Patent and Trademark Office. Yes, interviews can be challenging. I was representing a German physician inventor (an older gentleman — still an avid weight-lifter, the Jack LaLanne of gynecologists) who attended along with his German counsel and his big pharma licensee (coincidentally, also a weight-lifter).
Prosecution had been stalled and the examiner had become entrenched in her position. The stakes were high. I just met our team for the first time in person an hour or so before the interview. My challenge here was to quickly assess and effectively reign in the strong personalities, while orchestrating the relevant contributions of the parties. The inventor liked to talk (which can be very helpful, or not) and the licensee had his own agenda. With some finesse, body language and several versions of back-up claim language, we prevailed.
Q: What aspects of your practice area are in need of reform and why?
A: In my opinion, we need greater certainty surrounding patentable subject matter under 35 U.S.C. §101 in the biotech and diagnostic space (as well as computer-implemented innovation). Many of my clients are uncertain about the validity of their patents and patentability of their applications. Their investors are also uncertain. Licensees and licensors are in discussions. The developers of personalized medicine and biomarker-based innovations are in a panic. The “laws of nature, natural phenomena, and abstract ideas” exception to patentable subject matter is growing larger, while everything under the sun is shrinking. Isolated DNA may be at risk as the Federal Circuit revisits Myriad. Despite the U.S. Supreme Court’s carve out, even administering known drugs for new indications could fail to clear the §101 bar in the future, should Prometheus or its progeny be broadly interpreted. While I doubt that such a gloomy outlook is likely, it is possible.
Uncertainty is the problem, because it increases risk, which chills investment. Consequently, thoughtful, targeted and timely reform, whether judicial or legislative, is needed to restore greater certainty surrounding patentable subject matter. I am optimistic that even in the worst case scenario, e.g., if the “laws of nature, natural phenomena, and abstract ideas” exception is given its broadest interpretation, the biotech and pharma industries, including diagnostics and personalized medicine, would reinvent successful strategies for securing sufficient market exclusivity to attract investment dollars. Many of the recent cases in this area, including Prometheus, have emphasized the value and strength of patenting the constructs, devices, molecular tools (specific antibodies) for diagnostics (and therapies) — rather than the initial discovery and/or the broader concepts behind that discovery.
Q: What is an important issue or case relevant to your practice area and why?
A: Related to the previous question, the Supreme Court’s opinion in Prometheus sent shock waves through my practice area. My clients in the medical diagnostics space have been scrambling to develop alternative strategies to protect a business model that is still attractive to investors. At my firm, we gathered in practice group luncheons following Prometheus to develop new claim strategies and business recommendations for our clients. We held seminars and forums for clients and in-house counsel.
The Prometheus case and its progeny may present as big an issue as health care reform. When health care reform passed in 2010, money flowed from “curing cancer” type projects into diagnostics. Following Prometheus, money receded from diagnostics in search of commercial projects having less uncertainty. The judicial fallout from Prometheus (including Myriad on GVR order to the Federal Circuit) will likely determine where the money goes in the future — whether it continues to migrate toward later stage, lower risk, specific products, which fall more clearly outside of “laws of nature, natural phenomena, and abstract ideas” exception, or whether it again flows back into early stage innovations, personalized medicine and method based diagnostics.
Q: Outside your own firm, name an attorney in your field who has impressed you and explain why.
A: The list of impressive attorneys is long. One attorney outside my firm that I have been impressed with is Susan Hendrickson (Arnold & Porter). We have worked together on two related, technology-heavy, complex deals for a mutual client. I managed the IP due diligence and Sue seemed to manage everything else, including the corporate and regulatory due diligence, deal structure and client expectations. The number of moving parts she was juggling was impressive by itself — but the confidence she projected throughout, and her calming influence on the whole team and opposing counsel was even more impressive. I look forward to working on another deal together.
Q: What is a mistake you made early in your career and what did you learn from it?
A: One of my start-up clients was drawn into a bet-the-company interference proceeding involving a patent covering the company’s core technology — a patent that I had written as a first-year associate and prosecuted to issuance. I was emotionally invested in the outcome. When it came time to depose the senior party’s expert, I wanted to make him look bad. With the administrative patent judge on the phone, we grilled the expert on complex textbook theory related to the underlying technology. He did look very bad. Although I thought we destroyed the expert’s credibility, the APJ bemoaned our attack and found that the expert’s conclusions were nonetheless credible, despite his flawed understanding of theory. I learned to keep my emotions out of my practice and to attack the relevant conclusions rather than any individual.
The opinions expressed are those of the author and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
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