IP Law, Biotech And Business And Coping With Bilski And KSR

Editor: Jennifer, please describe your scientific background and why you became interested in patent law.

Camacho: In college, my focus was on cell and structural biology. I continued my interest in science as a research assistant at Harvard and at the University of Illinois. Although pure science is a discipline in which I developed a deep interest, I was fascinated by the challenge of finding business applications for its fruits. While I was working at Harvard, I looked for ways to use my science degree. That's when I started to think about going into law.

Once I got to law school, I found that the intellectual disciplines I acquired in science were helpful. The analytical way of thinking about things is very similar. When I was a summer associate at a law firm, I gained experience working in different practice groups and found that intellectual property was the field where I could best use my scientific training.

While I was in law school I continued to work at Harvard and also part time at a law firm where I transitioned from being a scientist to being a lawyer. After I graduated from law school, I purposefully chose a general practice firm that had a very strong IP department to start my career. I first learned about patent law and patent prosecution in my early stages of training. Later, I learned the litigation, enforcement and licensing pieces.

Given my scientific training, the practice of IP is the perfect combination of the things that I was looking for in a career. I get to work not only with creative scientists, but also with enterprising business people seeking practical applications for cutting-edge science. It's exciting to be an integral part of an effort to take a figment of somebody's imagination and convert it to a valuable asset.

Editor: What is the most exciting aspect of your current practice?

Camacho: Working with investors and with executive-level management teams on issues where IP strategy intersects with the business plan. An important part of that involves advising companies about how to tell their IP stories and how to package those stories for partners, their investors and potential merger partners. These stories cover such things as the valuation of their IP, the strength of their IP and where they stand in relation to their competition. The value that I bring to the table is my understanding of both the technology and patent law.

Editor: Does Proskauer make it possible for you to draw upon the expertise of others within the firm?Camacho: Absolutely! We have a tremendous wealth of experience and specialized skills spread over our different departments. When new issues arise, I can tap into these resources with a single phone call. In fact, I would say that I work as closely with my colleagues in the corporate department as I do with my litigation colleagues. For example, I often work on deal teams comprising attorneys from our corporate, tax and IP groups for clients who are involved in IP- or technology-driven business transactions, such as patent licensing or investments in the life sciences space. This is one reason why our clients prefer to work with Proskauer rather than going to a patent boutique where the scope of available expertise may not bridge the full extent of the legal and business issues that our clients have to deal with.

Editor: Is the firm integrated in such a way that you can reach out to someone in another office who might have some very specialized knowledge?

Camacho: All of the offices are electronically networked through a secure but robust IT infrastructure which includes a centralized document management system. That means that an attorney in the Boston office can access a document created in the New York office with no more effort than would be required to access a document created in Boston. We also have networked video and telephone systems. When I call a colleague in New York, it's just another extension.

Editor: You left the firm to become chief patent counsel and vice president of intellectual property of Codon Devices, a leading New England biotech company in the emerging field of synthetic biology, and rejoined Proskauer last year. How has that experience helped you to better serve your clients?

Camacho: One reason I decided to go in-house was to better understand the concerns of inside counsel, as well as the business context of the IP issues I was handling for my clients. Once I got there, I realized that it was a completely new world - and I had to come up-to-speed in a hurry. I had to immerse myself in world of emerging tech start-ups and figure out my role as a member of the executive management team as well as the chief patent counsel..

Some of the best advice I got early on was from a former colleague of mine who was in-house with another company. He told me to never forget that I was invited to the table because I was a patent lawyer, but once I'm at the table, I should give the company everything that I have. I've seen many lawyers struggle with the perception of a line that they, as legal counsel, can and will not cross when a "legal issue" becomes a "business decision." Having been on the inside, I know that there is no such line. Taking that back to private practice, I focus on providing effective legal advice no matter where an issue falls on the continuum between law and business. Whether I am working with private or public companies, universities or hospitals, I treat the legal advice that I give as part of a conversation that results in a business decision by the client. What being in-house taught me is that clients expect strategic business counseling on legal matters rather than strictly legal advice.

The exciting thing about being an IP practitioner, whether as in-house or outside counsel, is being part of a creative process that results in adding value to the relationship - you are not a mere gatekeeper adding cost to an administrative activity, but rather an integral part of creating value in a profit center. The more inclusive a company is in involving IP practitioners in the whole thought process, the better the product at the end of the day.

Editor: Does the in re Bilski test of patentability create problems when applied to something like synthetic biology which involves manipulation of DNA?

Camacho: In re Bilski applies the "machine-or-transformation" test in determining the patentability of a process or method. The Federal Circuit ruled that a process claim constitutes eligible subject matter only if it is tied intimately to a machine or a device that is necessary or particular to the process or if it transforms a particular article into a different state or thing.

This decision may open the door to additional patentability challenges in the biotech field in the case of issued patents and pending applications where pre- Bilski claims may not recite a tie-in with a machine or device or specify a resulting transformation. That's a good reason for any company to review their patent portfolio for weaknesses in view of Bilski and to evaluate options for strengthening their portfolio. With good patent counseling and clever drafting, many biotech method and process inventions can be claimed to meet the requirements of in re Bilski .

Editor: Let me ask you about the KSR decision. Does the U.S. Supreme Court's redefinition of the "obviousness" test materially limit the patentability of advances in the biotech field?

Camacho: In KSR, the Supreme Court refined the legal analysis for determining whether an invention would have been "obvious" and, therefore, not patentable. Traditionally, the test for obviousness required that there be some express teaching, suggestion or motivation to combine or modify what was known in the prior art to produce the claimed invention. In KSR , the Supreme Court provided a more flexible approach that allows for the "ordinary creativity" of one skilled in the art at the time of the invention to serve as the spark behind the combination or modification that resulted in the claimed invention. This analysis can be challenging when you are dealing with the rapidly advancing biotech field. Often, biotech patent applications are being examined in the Patent Office years after the technology was invented. What would have been revolutionary thinking at the time of the invention may be improperly viewed later as "ordinary creativity" simply because the science has moved so far beyond that point during the intervening time. Nevertheless, hindsight is impermissible in examining the patent application. Under KSR , the patent examiner will have to establish not only the state-of-the art but also the state-of-mind of one skilled in the art at the time of the invention.

Editor: Has the current economic and financial crisis had an impact on your practice?

Camacho: So far we have not seen major cutbacks in the work we are doing for biotech companies. It may be because biotech is considered a long-term play in that if you don't protect your IP assets now, it's not just going to hurt you in this year, it's going to hurt you conceivably for the next 20 years. Budgetary constraints are causing some clients to examine ways to realize current value from their IP assets. I have a number of biotech clients that are looking closely at their overall patent portfolio to identify IP that covers their core technology and then taking a look at ways to monetize their other IP assets. Companies may have very broad patents that have wide applicability. If the value of the patent to the company is limited to a particular field, they might consider licensing it to a third party for use in a different field or for a non-competitive use. Under some circumstances, the company may require its licensee to pay costs associated with obtaining the patent. Using this approach, the client can generate royalty income without having to bear those costs directly.

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