Amendment of the U.S. patent law[2] on November 1, 1995 to permit claims for biotechnological processes where at least one of the starting materials or end products are novel and nonobvious and the Court of Appeals for the Federal Circuit's decisions in In re Brouwer[3] and In re Ochiai[4] are expected to have significant impacts on the prosecution and litigation of process claims for chemical and biotechnological inventions.
In 1985 the Court of Appeals for the Federal Circuit decided In re Durden[5]. For the past ten years, this decision has affected patent prosecution and litigation particularly in the fields of chemistry and biotechnology. The claim at issue in Durden defined a process of making novel carbamate products from novel oxime starting materials. The claim was rejected on the ground that it was obvious over a reference that taught the "instant process with similar reactants" - a process of reacting an oxime group to form a carbamate ester.
The Federal Circuit in affirming the Board of Patent Appeals and Interferences decision upholding the Examiner's rejection of the process claim, 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 nonobvious.
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. The Process Patent Amendments Act (35 USC 271(g))[6] 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".[7]
Prior to the enactment of the amendment to section 103 of the U.S. patent law[8] on November 1, 1995 there were numerous attempts to overrule Durden by enacting legislation that would provide that in a known process if the starting material or the end product were new and nonobvious the process using the new and nonobvious starting material or the process for making the new and nonobvious product would be patentable. The various legislative proposals were controversial as some were directed to process claims in all fields while others were limited to claims for chemical and biotechnological processes and a further group only to biotechnological processes. Although favored by the biotechnology industry, legislation to overrule Durden was opposed by many on the basis that patentability should be decided on a case by case basis and that there should be no per se rule of patentability. Others could see no basis for there being different standards of patentability depending upon the industry in which the invention was made.
As finally enacted the legislation was confined to biotechnology and adds new subsection(b) to 35 USC 103.
35 USC 103(b), which may be applied to any patent application (including reissue applications) filed on or after November 1, 1995 and to any patent application pending on that date, provides a per se rule that a biotechnological process using or resulting in a composition of matter that is novel and nonobvious will be considered nonobvious if claims to the process are contained either in the same patent application as the claims to the and nonobvious composition or in a separate application having the same effective filing date as the claims to the new and nonobvious composition made or used in the process. If separate patents issue for the composition and the process, the patents will expire on the same date. 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 35 USC 103(b) 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).
Procedurally, the applicant has a choice whether to have process claims examined if 35 USC 103(b) applies. If an applicant elects to invoke 35 USC 103(b) during prosecution there is no requirement for the Examiner to conduct a search of the prior art to determine whether the process claims are nonobvious over the art. If the claims for the product are found to be invalid and the process claims were granted based on the provisions of 35 USC 103(b) there will be no presumption of nonobviousness of these process claims.
If an applicant elects to proceed by way of 35 USC 103(b) a petition must be filed:
[The] petition must establish that all the requirements set forth in section 103(b) have been satisfied. An election will normally be considered timely if it is made no later than the earlier of either (1) the payment of the issue fee, or (2) the filing of an appeal brief in an application which contains a composition of matter claim which has not been rejected under 35 U.S.C. section 102 or 103.
As an alternative to proceeding under section 103(b) the applicant whose composition is new and nonobvious can have full examination of the biotechnological process claims including a search of the prior art conducted.
At the time the change in the law was enacted, it was expected that a large number of applicants claiming biotechnological processes would choose to proceed in accordance with section 103(b). However, in December 1995, the Court of Appeals for the Federal Circuit decided 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 nonobvious product. In both cases the Federal Circuit criticized the Patent Office's routine application of In re Durden when a known process was used even though one or both of the starting products and end products was novel and nonobvious. The Federal Circuit stated that the correct test to be used to determine whether the known process was nonobvious was the test set out by the United States Supreme Court in Graham v. Deere[9].
The Federal Circuit considered that "language in a process claim which recites making or using a nonobvious product must be treated as a material limitation and a motivation to make or use the nonobvious product must be present in the prior art for a section 103 [obviousness] rejection to be sustained.[10] In Brouwer the applicant claimed a process for preparing a sulfoalkylated resin. Neither of 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 nonobvious acid to make a new and nonobvious cephem compound. The Federal Circuit noted 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 rather than applying the Graham v. Deere criteria. The Federal Circuit noted 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 and thus, reversed the obviousness rejection.
Following the enactment of 35 USC 103 (b) and the In re Brouwer and In re Ochiai decisions, the Patent Office on March 5, 1996 issued a Notice of Treatment of Product and Process Claims. The notice directs examiners in examining claims for a process for making or using a novel and nonobvious composition to consider the claim as a whole and view the making or using of a novel and nonobvious composition as a material limitation. The Graham v Deere analysis is to be used to consider what the prior art must have suggested to one of ordinary skill in the art at the time the invention was made to determine whether an applicant's claimed invention would have been obvious.
The notice points out that a restriction requirement under 35 USC 121 may still be made between the product and process claims. If the product claims are elected and found to be patentable, the process claims may be rejoined in the application if the "process claim depends on or otherwise includes all the limitations of an allowed product claim."[11] The rejoined process claims will then be examined for patentability including a search of the prior art.
The notice also discusses the possibility that for biotechnological processes an applicant may elect to proceed in accordance with newly enacted section 103(b).
The notice states that a patentee may file a reissue application[12] to permit consideration of process claims which qualify for section 103(b) treatment "if a patent is granted on an application entitled to the benefit of section 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 contacts in the Patent Office indicate that it may well adopt the position that a process claim for making or using a novel and nonobvious 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.
It is expected now that the number of process claims allowed by the Patent Office will increase and that most applicants even those a claiming biotechnological process will elect to have full examination of the process claim. Process claims will provide the patentee with an added weapon to prevent the importation of products made by its patented process as the patentee will be able to rely on the Process Patent Amendments Act.
