01 Dec Describe your invention, or your biotech patent may be worthless
The U.S. Supreme Court made a patent-law decision on Monday that could have multibillion-dollar ramifications for patent holders in the biotechnology sector.
The court denied an appeal in Univ. of Rochester v. G.D. Searle & Co. This effectively solidifies the decision that was made by the U.S. Court of Appeals for the Federal Circuit, which invalidated a biotech patent because the inventor did not provide an adequate written description of the invention.
Granted patent rights are designed to be quid pro quo. The federal government confers a limited monopoly in the claimed subject matter in exchange for meaningful public disclosure of the invention. Society benefits through shared knowledge. In return, society, via our government-issued patents, gives exclusive rights to practice the invention for a limited time.
In addition to the statutory requirements of utility, nonobviousness, and novelty, U.S. courts have determined that a patent application has three separate requirements that must be met in order for a patent to be valid. The patent application must describe, enable, and set forth the best mode of carrying out the invention.
If a patent is issued having not sufficiently described the invention, the claims may be determined to be broader than the inventor’s contribution to the public. In such a case, there is insufficient quid pro quo because the inventor can be said to have received more than his fair share. Courts are blunt instruments, and they may use this to invalidate the entire patent. An adequate written description promotes the advancement of science and research through teaching the public that which it needs to know to practice the invention.
Scientists at the University of Rochester developed a screening assay for use in determining if a particular drug exhibited selectivity for inhibiting the activity of COX-2 without inhibiting COX-1 activity. The assay was determined to be significant in the production and discovery of non-steroidal and anti-inflammatory drugs.
The University of Rochester ultimately received a patent (6,048,850) which covered methods for “selectively inhibiting PGHS-2 activity in a human host, comprising administering a nonsteroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.” On the day the patent was issued, the University of Rochester filed suit against G.D. Searle & Co., Monsanto Co., Pharmacia Corp, and Pfizer, alleging that the sale of Phizer’s Celebrex and Bextra, both COX-2 inhibitors, infringed upon Rochester’s patent. The patent was found to be invalid based upon a failure to meet the written description requirement.
The patent claimed a method which included administering a non-steroidal compound in a human host, yet the patent failed to describe any non-steroidal compounds for use in human hosts. Essentially, the application described what the compound does and not what the compound is. This is inadequate according to the court because it fails to teach enough to enable the public to practice the invention.
What is an adequate written description?
An adequate written description may vary dependent upon the technology involved. In the case of biotechnology, the definition of an adequate written description can only be fairly described as muddled in light of the most recent Federal Circuit decisions. Statutes and case law provide that the written description of the invention shall describe the invention “in such full, clear, concise, and exact terms” that necessarily establish that the inventor was in possession of the claimed invention. The claimed invention refers to all the limitations and elements which are being asserted in the claims. In order to be an adequate written description the invention must clearly convey to those skilled in the particular technology that the inventor possesses the claimed invention.
In the case of Noelle v. Lederman, the Federal Circuit decided that a patent for an antibody need not provide a written description of the antibody. However, provided that an application discloses a “fully characterized antigen”, the application may properly “claim an antibody by its binding affinity to that described antigen.” At first glance, this may appear to contradict the Rochester decision left standing by the Supreme Court that required description of a compound. But this can be justified, since antibodies are not defined by their physical structure but by their binding affinity to antigens. Thus, an antibody may be claimed without providing a physical description of the antibody, so long as there is a clear definition of the antigen.
What does this mean for biotechnology?
A biotech company’s foundational asset may be lost, along with the company itself, if a patent is invalidated for failing to provide an adequate written description. This can translate into tremendous cash flow considering that important biotech patents have the potential for generating millions of dollars a day.
As in Rochester, a patent may be invalidated for lacking an adequate written description of the invention. This suggests that when drafting your patent applications, “more is better.” The greater detail and more complete disclosure of the invention provided, the less chance that a patent may be invalidated for an insufficient written description. The Rochester decision solidifies the importance of properly preparing a patent application by thoroughly describing the claimed invention. It makes clear that patent holders will not be able to assert rights that they have not clearly described in a way that shows they have the invention in their possession.
Once an application has been filed, the addition of “new matter” into an application is not allowed. The date of priority for an application is established upon filing an application that fulfills the statutory requirements. An inventor may add additional description to the application, but it must then be filed as a separate “child” application. The problem with this procedure is that the “new matter” added would have a priority date of the “child” application and not of the “parent.”
For biotechnology related inventions a matter of days can translate into considerable monetary differences, both at the end of the patent’s life and in determining whether it will issue at all. If possible, it is best to thoroughly describe and broadly claim an invention in an application filed as early as possible.
Though the requirement is not excruciatingly stringent, it is more than likely that a written description covering only the invention’s function, rather than its structure, would be inadequate. In order to avoid problems during and after prosecution of a patent application, inventors must be cognizant of thoroughly describing their invention.
It is good practice to carefully compare claims to the specification in order to verify that the specification supports the claimed subject matter. The words of the claims should be reflected in the written description by clear and unambiguous definitions, woven into a story that completely describes how to practice the invention. Keeping this in mind while preparing the application may take additional time, but is better than the alternative: an invalid patent.
The opinions expressed herein or statements made in the above column are solely those of the author, & do not necessarily reflect the views of The Wisconsin Technology Network, LLC. (WTN). WTN, LLC accepts no legal liability or responsibility for any claims made or opinions expressed herein.