ANTIBODIES AND PATENTS: A LOCK AND A KEY, OR A KEYCHAIN FULL OF KEYS?
(WITH COMMENTS ON THE CARROT AND THE STICK OF THE PATENT SYSTEM)
As with many technologies, the standards for patentability for antibodies has evolved over time. The length of the stick (representing the distance of innovation to the reward) and the size of the carrot (the reward in term of patent claim scope) in our incentive based patent system may have made a logical progression. Perhaps the stick has gotten longer and the carrot smaller. (See: Amgen v. Sanofi, Fed. Cir October 2017). At least we were not “shown the carrot and given the stick” as the adage goes around corporate review time.
Historically, the relationship of antibody and antigen being a lock and key relationship has provided an exception to the enablement / written description paradigm, where describing the antigen in reasonable detail under the circumstances can enable and describe the matching pair of the specific binding duo.
As the technology, and value of antibodies, increases, perhaps this “antibody exception” is headed for the dust bin. Antibodies are becoming more like therapeutics, which tend to have a higher burden of production and persuasion as to patentability before the USPTO and the courts. The rewards being large, and the desire not to have “each and every” possible antibody for a therapeutic target tied up could be a desirable solution to keep the balance of promoting the progress of the useful arts and sciences with the granting of exclusive rights. (See: U.S. Constitution, Article I, Section 8, Clause 8).
Amgen may have done just that in providing that for compliance with the written description requirement, the description of the antibody is to be considered, such as sequencing, deposit, and the like. The analogy that an antigen/antibody specific binding pair is not just a lock and a single key, but a lock and a keychain with perhaps millions of keys is perhaps helpful in the Amgen analysis.
The progressive nature of technology and the law, and keeping the incentive system in balance, perhaps justifies this trend of keeping moving the stick further and further. We have of course seen this with the patentability of nucleic acid sequences, starting with the case line of Duel/Bell/Fiers/Lilly (relatively broad claims for nucleic acid molecules based on the sequence, function, and source organism) and progression to the current Association for Molecular Pathology v. Myriad Genetics, U.S. Supreme Court (June 2013) (focused claims for nucleic acid molecules with strict limitations of claim coverage based on product of nature limits of patentability).
All in all, it is helpful to bear in mind that the patent system, and thus patents, are at their core economic instruments, and the exclusivity component of the patent rights has a character of a monopoly. The monopoly rent imposed is born by the consumer/public as a tax, which needs to be balanced out by a benefit to the public. That balanced benefit is the fruit of the incentive structure of the patent system. So long as the overall societal gain from the patent system outweighs the burden of increased costs of goods/services, all should be well.
This economic balance is a hard one to strike, and it is hoped that the United States Court of Appeals for the Federal Circuit, U.S. Supreme Court, and Congress can maintain that balance without shifting too much or too quickly. Some would say that recently patents have been “shown the carrot and given the stick” rather been incentivized to invest and invent. Time will tell.
February 5, 2018, modified February 7, 2018
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