US - Biotechnological and Chemical Process Patents

US - Biotechnological and Chemical Process Patents

United States - Biotechnological and Chemical Process Patents

The U.S. patent law was amended on November 1, 1995, by adding new sub-section 35 USC 103(b) to provide that a biological process using or resulting in a composition of matter that is novel and non-obvious will itself be considered non-obvious if claims to the process are contained either in the same patent application as the claims to the new and non-obvious composition or in a separate application having the same effective filing date as the claims to the new and non-obvious composition made or used in the process. In addition it is required that the composition and the process at the time they were invented were owned by the same person or subject to an obligation of assignment to the same entity.

A biotechnological process is defined in the law as:

(A) a process of genetically altering or otherwise inducing a single or multi celled organism to (i) express an exogenous nucleotide sequence; (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence; or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by (A) or (B) or a combination of (A) and (B).

This law was enacted in response to the controversial decision of the Court of Appeals for the Federal Circuit in In re Durden. In that decision the Federal Circuit stated that, although an old process may become a new process when a previously unknown starting material is used and the product produced is new, this does not necessarily mean that the whole process has become non-obvious. Although the claim at issue in Durden was for a chemical process, the patenting of biotechnological processes was also affected by the Durden decision. For example, although a host cell for producing a genetically engineered form of protein could be patented, the use of the host cell to produce the protein was not patentable unless there was something inventive about the method used. In addition, the import of finished pharmaceutical products which were produced abroad using a host cell that was patented in the U.S. was legal because there had been no use of the patented material in the U.S. and the Process Patent Amendments Act did not apply because one could not secure a U.S. patent for the process used. The problem was exacerbated by the fact that in several countries there has been a problem in securing patent protection for the host cells used since these were regarded as being unpatentable "living matter".

When the change in the law was enacted last November, it was expected that a large number of applicants claiming biotechnological processes would choose to proceed in accordance with 35 USC 103(b). However, in December 1995, the Court of Appeals for the Federal Circuit issued two decisions, In re Brouwer and In re Ochiai, in which the issue before the court was whether as a general proposition a known process could be patented if it were limited to making or using a non-obvious product. In both cases the Federal Circuit criticized the Patent Office's routine application of Durden when a known process was used even though one or both of the starting products and end products was novel and non-obvious.

The Federal Circuit considered that "language in a process claim which recites making or using a non-obvious product must be treated as a material limitation and a motivation to make or use the non-obvious product must be present in the prior art for an [obviousness] rejection to be sustained." In Brouwer the applicant claimed a process for preparing a sulfoalkylated resin. Neither the starting materials (resin substituted methyl reactant) nor the sulfoalkylated resin that was produced were known or obvious and the Federal Circuit noted that none of the references cited by the Examiner contained any suggestion or motivation either to use a resin substituted methyl reactant or to obtain the product made by the claimed process and so the finding of obviousness was reversed.

Similar issues were addressed by the court in Ochiai. The claim in question defined a process which used a new and non-obvious acid to make a new and non-obvious cephem compound. The Federal Circuit noting that the Examiner had conceded that the acid used and the product made were not taught in the prior art and had relied on Durden in making the rejection. The Federal Circuit, noting that it would not have been obvious to choose the particular acid used by Ochiai as an acylating agent for the simple reason that the particular acid was unknown, reversed the obviousness rejection.

The Patent Office has now issued a Notice of Treatment of Product and Process Claims that directs examiners in examining claims for a process for making or using a novel and non obvious composition to consider the claim as a whole and view the making or using of a novel and non-obvious composition as a material limitation.

The notice states that a patentee may file a reissue application to permit consideration of process claims which qualify for §103(b) treatment "if a patent is granted on an application entitled to the benefit of §103(b) without an election having been made as a result of error without deceptive intent". Although not stated in the notice, if a patentee did not obtain process claims either because they were rejected based on an examiner's application of Durden or an applicant did not claim the process disclosed in the application because of Durden, a reissue application can also be filed. 35 USC 251 provides that "[n]o reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent." It, however, may be possible to obtain process claims in reissue patents of patents granted more than two years ago. Although our sources at the PTO indicate that it may well adopt the position that a process claim for making or using a novel and non-obvious composition does not enlarge the scope of the claims of the original patent and so permit reissues to add process claims, no final determination on this has yet been made. Patentees may want to review their patent portfolios to determine whether reissue applications should be filed in an attempt to add process claims to their patents.