Disclosure: The price of patent protection
Disclosure is an important requirement for obtaining a patent. Anything less is dangerous.
Where is the profit in forging a Golden Bullet cure, if it is not solely yours to make, use, and sell? Patented claims, when supported by adequate disclosures, properly confer the power to exclude others from practicing the patented technology. Strong patented claims are the sword by which to recover investments, gain competitive advantage, and take market share. Inadequately supported claims can be invalidated in litigation, and patent protection lost.
The power granted to inventors through patent protection arises from the U.S. Constitution empowering Congress to secure, for limited times, the exclusive rights of authors and inventors to their writings and discoveries. The U.S. Patent and Trademark Office is responsible for awarding patent protection. The price of patent protection is disclosure. This means that the United States will protect a patent holders right to prevent others from making, using, and selling the invention, only if the invention is adequately disclosed to the public. If it is not, the patent may be rejected or it could be invalidated in litigation. The specification is the part of a patent application that contains the inventors disclosure. The requirements for adequate disclosure in the specification are found in the first paragraph of 35 U.S.C. § 112, which states:
The specification culminates with the claims to be patented. This is provided for in the second paragraph of 35 U.S.C. § 112:
It is a serious mistake for patent applicants to view compliance as too great a price to pay and not provide complete information.
The written description requirement
The written description must define the invention. This is achieved by precise terminology and careful construction of the language used in the written description. For example, disclosure of the compound D-ribulofuranose does not distinguish between the alpha and beta forms. If the invention requires the beta form, then α-D-ribulofuranose must be identified to render the written description sufficient.
In one case, the specification disclosed the use of a beneficial amount of methylsulfonylmethane, a compound for mammalian diet enhancement. The term beneficial amount was undefined in the specification. The Court determined that there was no basis for a filing date because of a failure to provide full, clear, concise, and exact terms, resulting in a lack of definiteness (7).
The enablement requirement
It is not necessary that the enablement be such that a person attempting to make or use the invention be successful on the first try. The law of enablement recognizes that some experimentation may be necessary, as long as the amount of experimentation required is not unduly extensive (8). Optimality is not required.
In one case, patented claims related to a cardioselective beta-blocking compound were invalidated in a holding that undue experimentation would be required to determine the proper dosage in order to practice the invention (9). The specification provided a description of the claimed drug, but the Court held that there was insufficient enablement of the manner and process of use of the drug. The Court held that, given the inadequate disclosure, a person skilled in the art would be unable to determine an effective dosage. Thus, the claims were held invalid.
In another case, patented claims related to genetic antisense technology used in transgenic tomato plant development were held invalid. The examples of artificial antisense presented in the specification did not contain examples of antisense regulation in genes other than those found in the prokaryotic organism E. coli (10). The Court determined that the disclosure of such examples was insufficient to enable the invention in plants.
The best-mode requirement
For example, one may disclose an invention relating to an organic molecule and its synthetic pathway that satisfies the enablement requirement. However, the disclosure of the best mode requires that if the applicant has developed specific instrumentalities or techniques, then they must be revealed (12). These best-mode techniques or instrumentalities could include details such as an original biological sample (i.e., a genetically engineered bacterium), the dosage and frequency of administration of a therapeutic compound, the most preferred composition, a key reaction temperature, the stereochemistry of a chemical structure, or the pore size of a membrane. Even trade secrets must be disclosed if they are part of the best mode for carrying out the invention.
The pressures on the inventor are powerful during the development of the disclosure, and passions can be intense. A disclosure of even the second-best mode, while retaining the best, clearly violates the best-mode requirement and invites a legal disaster (13).
The best-mode requirement is intended to ensure that an inventor plays fair and square with the public. It safeguards against any selfish desire one might have to obtain patent protection without full disclosure. The key issue is whether the best mode has been concealed from the public (13).
The inquiry into such compliance with the best mode is a question of fact focused on the inventors state of mind at the time the application was filed (11, 12). Invalidation of claims for failure of best-mode compliance requires proof that the inventor contemplated and concealed a better mode of carrying out the invention than was set forth in the specification (14).
Although the intentional concealment of best mode is an obvious violation of the law, a poor-quality disclosure can also lead to a holding of failure to disclose the best mode. An applicants disclosure can be so poor, or lacking in detail, as to effectively result in concealment (12, 13).
The views expressed in this column are those of the author and should not be attributed to Sughrue Mion Zinn Macpeak & Seas, PLLC, or any of its clients.