Monday the Federal Circuit released its en banc opinion in Ariad Pharmaceuticals, Inc. v. Eli Lily & Co., where the court addressed whether 35 U.S.C. § 112 has a written description requirement separate and apart from the enablement requirement. A substantial majority of the court (10 judges) joined in the majority opinion, with two judges dissenting. As summarized by the court:
We . . . read the statute to give effect to its language that the specification "shall contain a written description of the invention" and hold that § 112, first paragraph, contains two separate description requirements: a "written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]."
The Federal Circuit analyzed several old Supreme Court cases, and concluded that the Supreme Court, while not specifically calling this requirement a "written description" requirement, has consistently held that an inventor must do more than simply enable one in the art to make and use the invention claimed, but also must describe what the invention is.
This decision is not unexpected, and leaves intact the Federal Circuit's jurisprudence on the subject. In fact, one of the grounds for retaining the requirement is that forty years of case law has held such a requirement exists, and inventors have relied upon the requirement over the course of that time. The court was reluctant to upset the settled expectations of the patent community. The court also declined to set forth a rule where original claims always meet the written description requirement, noting:
Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result.
More detail of the en banc decision after the jump. Click here for our post regarding the original panel decision, which has much of the factual background of the invention at issue. Click here for a discussion of court's decision to grant en banc review, including the questions presented.
Federal Circuit to consider whether a separate written description requirement exists in section 112
In an en banc order Friday, the Federal Circuit announced it will rehear Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. en banc to consider whether there is a written description requirement in § 112 separate and apart from the enablement requirement. Specifically, the questions presented are:
- Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
- If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
Our post regarding the panel decision in the case may be found here. Judge Linn filed an opinion concurring in the panel's decision in order to restate his opinion that no such separate written description requirement exists in the statute. He now has his opportunity to convince his colleagues that there is no such requirement.
To read the order in Ariad Pharms., Inc. v. Eli Lilly & Co., click here.
When analyzing written description in interference, claims construed according to patent copied from
In a recent decision, the Federal Circuit reversed a district court's grant of summary judgment in a § 146 action brought after an interference proceeding at the USPTO. The district court agreed with the Board's decision to award priority to the senior party in the interference, granting the senior party's motion for summary judgment that its specification satisfied the written description requirement for the interference count. In coming to this conclusion, the district court construed the count by reference to the specification of the senior party's application, rather than by reference to the specification of the junior party's issued patent. The district court also determined the proper standard of review was for substantial evidence, holding the junior party did not advance any "meaningful evidence" apart from what was considered by the Board.
The Federal Circuit reversed. The court determined the district court erred both with regard to its determination that 1) the claims should be construed in light of the host application whose written description was being challenged and 2) that evidence proffered to the district court was insufficient to require de novo determination of the facts under § 146. The court reconciled two prior decisions, In re Spina and Rowe v. Dror, dealing with the proper source for claim construction in an interference. As described by the court:
[W]hen a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language. When a party challenges a claim's validity under § 102 or § 103, however, [the Federal Circuit] and the Board must interpret the claim in light of the specification in which it appears.Applying this law, the court construed the count in light of the proper specification. In light of the revised construction, the Federal Circuit reversed the district court's grant of summary judgment that the senior party's disclosure met the written description requirement and remanded with instructions to enter summary judgment for the junior party.
More detail of Agilent Techs., Inc. v. Affymetrix, Inc. after the jump.
Disclosure of compounds without link to claimed method fails to meet written description requirement
In a recent decision, the Federal Circuit reversed a district court's denial of judgment as a matter of law after a jury determined the asserted claims of an invention were not invalid under the written description requirement. The court, however, affirmed the district court's determination of no inequitable conduct.
The Federal Circuit held the jury lacked substantial evidence for its verdict. Specifically, the court noted that vague functional descriptions are essentially invitations for skilled artisans to conduct further research and therefore are not sufficient description to meet the written description requirement of § 112. The specification disclosed three classes of compounds that could be used in the claimed methods. However, it only disclosed specific examples of one of the classes of compounds, and did not disclose any examples of the described compounds actually linked to use in the claimed method. The patentee was further hampered in that the jury held the patent was entitled to a priority date of 1989, but most of the patentee's testimony and other evidence regarding the written description issue centered on the application's filing date in 1991. The court held none of this evidence could support the jury's verdict, as it was directed to the wrong timeframe. Therefore, the court held the written description requirement not met, and the asserted claims invalid.
The court affirmed the district court's holding of no inequitable conduct. Neither party contested the relevant acts (failing to correct a figure and to disclose certain non-prior art references that were relevant to patentability) were properly held material. The Federal Circuit agreed with the district court that there was insufficient evidence of intent to deceive to support a finding of inequitable conduct.
More on Ariad Pharms., Inc. v. Eli Lilly & Co. after the jump.
Thursday, the Federal Circuit held oral arguments in In re Kubin, a biotechnology case involving a patent over a gene sequence in humans, and specifically whether the claims were obvious. This was the first precedential decision by the Board of Patent Appeals and Interferences on the issue of obviousness in this field after KSR, so how the Federal Circuit comes out on the issue has the potential to greatly affect examination of biotechnology applications at the USPTO. We previously covered the Board's decision in the case in July.
The key issues addressed in oral arguments were whether the prior art, particularly Valiente (a reference teaching a similar protein in mice), rendered the claimed invention obvious, and whether the disclosure of essentially one sequence was sufficient to provide written description for all sequences with 80% similarity that still retain the function of the original gene. Oral argument focused largely on the obviousness issue. Many attended the arguments, including representatives from our office.
Click below for more detail of the arguments in In re Kubin.
In a recent decision, the Federal Circuit affirmed a distirct court's vacatur of a decision of the Board of Patent Appeals and Interferences. In an appeal of rejections in twelve different applications involving approximately 2,400 claims, the Board only addressed the rejection of 21 "represntative" claims pursuant to 37 C.F.R. § 1.192(c)(7) [now 37 C.F.R. § 41.37(c)(vii)]. The Board took this position that each of the claims in the groupings were rejected under the same statutory provision, even though the rejections were not necessarily based on the same limitations.
The district court held this was improper. Specifically, the district court held the Board could only group claims if the basis for the rejection was the same, which requires both the same statutory provision and the same underlying basis for the rejection. Here, because the rejections at issue were predominantly under the written description requirement, the district court held claims could only properly be grouped if the limitation that was allegedly not described was present in each of the grouped claims.
The Federal Circuit affirmed, agreeing with the district court's analysis.
More detail of Hyatt v. Dudas after the jump.
In a recent decision, the Federal Circuit affirmed the decision of the Board of Patent Appeals and Interferences sustaining in part the examiner's final rejection of the broadest claim in an application, directed to methods of treating neurofibrosarcoma using monoclonal antibodies. The Board reversed the examiner's rejection of the claim for lack of enablement, but sustained the rejection for lack of adequate written description. The Board agreed with the examiner that the single example provided of a functional monoclonal antibody for use in treatment and the method of its production did not provide sufficient support for the genus encompassing all such antibodies.
The Federal Circuit affirmed, finding the Board's conclusion supported by substantial evidence. The question turned on the level of variability within the claimed genus. There was evidence in the record that the species in the genus "would be expected to vary substantially," based on statements made in scientific literature (including one paper authored by the inventor). As described by the court:
The specification of the '749 Application does not characterize the antigens to which the monoclonal antibodies must bind; it discloses only the molecular weight of the one antigen identified in Example 2. This is clearly insufficient. The specification teaches nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method. While Alonso's claim is written as a method, the antibodies themselves are described in purely structural language – "a monoclonal antibody idiotypic to the neurofibrosarcoma of said human." This sparse description of antibody structure in the claim stands in stark contrast to the detailed method of making the antibodies found in the specification.
Accordingly, the court affirmed the rejection on written description grounds.
More detail of In re Alonso after the jump.
In a decision Friday, the Federal Circuit affirmed a district court's summary judgment of no anticipation, no invalidity for failure to comply with the written description requirement, and infringement, but reversed the district court's summary judgment of no invalidity based on obviousness. In an unusual procedural move, the parties stipulated that for the issues on which both parties moved for summary judgment, the district court could make findings of fact based on the summary judgment record, making it similar to an inter partes proceeding at the TTAB for those issues. This stipulation included all issues except obviousness.
The Federal Circuit found no clear error in the district court's determination of the other issues, but held there was a genuine issue of fact that should have prevented summary judgment on obviousness. The court noted the Graham factual inquiries underlying the obviousness determination were legitimately in dispute, thus rendering summary judgment inappropriate on that issue.
More detail of Commonwealth Sci. & Indus. Research Org. v. Buffalo Tech., Inc. after the jump.
Disclosure of gene from one bacterial source cannot support claims to gene from any bacterial source
In a recent decision, the Federal Circuit affirmed a district court's grant of summary judgment of non-infringement and invalidity of various claims of three patents. The district court held no genuine issue of fact existed regarding noninfringement or invalidity under the written description requirement.
The patents related to DNA polymerases, and the claims at issue covered plasmids containing the gene coding region of DNA polymerase from any bacterial source. The specifications, however, only disclosed successful use of the DNA polymerase gene from E. coli. Based on this limited disclosure, the court affirmed the district court's decision that, under Regents of University of California v. Eli Lilly & Co., there was inadequate description to support the broad claims. Specifically, in order to support the broad claim, "a person of skill in the art [must] understand that the genus that is being claimed has been invented, not just a species of the genus." Here, only a single species was described, rendering the claims to DNA polymerases from any bacterial source invalid as inadequately described.
More details of Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc. after the jump.