Genentech, Inc. v. Chiron Corp., 95-1505
| Decision Date | 25 April 1997 |
| Docket Number | No. 95-1505,95-1505 |
| Citation | 42 U.S.P.Q.2d 1608,112 F.3d 495 |
| Parties | GENENTECH, INC., Plaintiff-Appellant, v. CHIRON CORPORATION, Defendant-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
R. Danny Huntington, Burns, Doane, Swecker & Mathis, L.L.P., Alexandria, VA, argued for plaintiff-appellant. With him on the brief was Eric H. Weisblatt.
Harold J. McElhinny, Morrison & Foerster L.L.P., San Francisco, CA, argued for defendant-appellee. With him on the brief was Matthew I. Kreeger. Also with him on the brief were Michael M. Carlson and Debra A. Shetka, Morrison & Foerster L.L.P., Palo Alto, CA, and Robert P. Blackburn and Amy L. Collins, Chiron Corporation, Emeryville, CA.
Before RICH, PLAGER, and CLEVENGER, Circuit Judges.
Genentech, Inc. (Genentech) appeals from the grant, by the United States District Court for the Northern District of California in No. C-94-3334 CW, 1995 WL 450846 (N.D.Cal.1995), of summary judgment in favor of Chiron Corporation (Chiron) in an interference between Genentech and Chiron involving a DNA construct on the ground that Genentech's claimed invention is not within the scope of the sole interference count as properly interpreted. We reverse and remand to the district court for further proceedings in accordance with this opinion. 1
This case arises from Patent Interference No. 102,208 in the United States Patent and Trademark Office (PTO) between two copending applications: United States Patent Application No. 06/506,078, entitled "Preparation of Human IGF and EGF Via Recombinant DNA Technology," (Lee application) by inventors James M. Lee, Axel Ullrich, and Arjun Singh (collectively Lee) and United States Patent Application No. 06/922,199, entitled "Hybrid DNA Synthesis of Mature Insulin-Like Growth Factors," (Barr application) by inventors Philip J. Barr, James P. Merryweather, Guy Mullenbach, and Mickey S. Urdea (collectively Barr). The Lee application was filed on June 20, 1983 and the Barr application was filed on October 23, 1986 and accorded the benefit of United States Application 06/487,950, which was filed on April 25, 1983. Therefore, Lee, whose application was assigned to Genentech, was the junior party and Barr, whose application was assigned to Chiron, was the senior party.
The sole count of the interference is identical to claim 22 of Barr's application, and reads:
A DNA construct comprising a sequence coding for human insulin-like growth factor--I joined in proper reading frame with Saccharomyces alpha-factor secretory leader and processing signal sequence. 2
Saccharomyces, commonly known as baker's yeast, naturally secretes a small, thirteen amino acid pheromone known as alpha factor during its reproductive cycle. As a first step in this process, the yeast cell produces a precursor protein from the DNA sequence encoding alpha factor that consists of a secretory leader, which serves to signal the cell to process the precursor protein, followed by four copies of the alpha-factor protein separated by processing sequences of six or eight amino acids each. Each processing sequence is recognized and excised by an enzyme in the yeast cell to release the four copies of the alpha factor outside of the yeast cell. As a result of this process, four copies of mature alpha-factor protein are secreted from the yeast cell for each precursor protein.
Human insulin-like growth factor-I (IGF-I), is a growth-promoting protein that mediates the effect of human growth hormone. It is undisputed that human IGF-I consists of a specific sequence of seventy amino acids that was published in 1978. See Ernst Rinderknecht and Rene Humbel, The Amino Acid Sequence of Human Insulin-like Growth Factor I and Its Structural Homology with Proinsulin, 253 J.BIOL.CHEM. 2769 (1978).
Lee and Barr sought to produce mature IGF-I by adapting the Saccharomyces DNA encoding the gene for the precursor protein. Utilizing a DNA construct with only one copy of alpha-factor protein, both Lee and Barr replaced the DNA sequence of the precursor protein encoding alpha factor with a DNA sequence encoding IGF-I. This new DNA construct is then inserted into an expression plasmid, and transformed into a yeast cell. The goal of both Lee and Barr was for such a transformed yeast cell to secrete some form of human IGF-I.
In replacing the DNA sequence encoding alpha factor with that encoding IGF-I, Lee, however, added twenty-seven additional nucleotide bases constituting a collagenase cleavage site between the DNA coding for the alpha-factor processing sequences and human IGF-I. When this construct is inserted into a yeast expression plasmid and transformed into a yeast cell, the cell secretes a "fusion protein" or "modified IGF-I" consisting of a collagenase cleavage site at the carboxy terminal of human IGF-I.
In analyzing Lee's case for priority, the Board of Patent Appeals and Interferences (Board) rejected Barr's argument that Lee's DNA construct fell outside of the scope of the count because when inserted into a plasmid and transformed into a yeast cell, it would cause the yeast cell to produce a fusion protein. The Board held:
The interfering subject matter, as defined by count 1, is directed to a DNA construct comprising two components, i.e., a DNA sequence coding for human IGF-I and a Saccharomyces alpha-factor secretory leader and processing signal sequence. Each of these components are [sic] made up of nucleotides and must be present in Lee's DNA construct in order to fall within the scope of the count. As long as these two components are present, other materials may also be present because the term "comprising" permits their inclusion. Thus, we view count 1 as being directed to a DNA construct which encodes IGF-I as either a mature protein or a fusion protein. Since the DNA construct made by Lee encodes IGF-I as a fusion protein, the Lee proofs fall within the scope of the count.
Lee v. Barr, Patent Interference No. 102,208, Slip. Op. at 8 (BPAI July 19, 1994).
The Board held, however, that Lee had failed to prove any practical, therapeutic utility of its fusion protein including a collagenase cleavage site in addition to IGF-I. Therefore, the Board awarded priority to the senior party, Barr.
Genentech, the assignee of the junior party Lee, filed a civil action under 35 U.S.C. § 146 in the United States District Court for the Northern District of California to challenge the Board's award of priority to Barr. Chiron, the assignee of the senior party Barr, moved for summary judgment, again alleging, as it had before the Board that Genentech's claimed invention of a DNA construct encoding modified IGF-I was not within the scope of the interference count as properly interpreted. The district court granted Chiron's motion for two reasons. 3
First, the district court found that the count was directed to a DNA construct that codes for authentic or mature, human IGF-I. The district court found that the term "coding" in the field of biology connotes the protein that results from expression of a particular DNA. Therefore, the court concluded that "[s]ince Genentech's DNA construct codes for a sequence of 79 amino acids, consisting of human IGF-I plus nine additional amino acids, rather than for human IGF-I alone, it is outside the plain meaning of the language of the count." Genentech Inc. v. Chiron Corp., 1995 WL 450846, at * 4 (N.D.Cal.1995).
Second, the district court agreed with Chiron that the only interpretation of the word "joined" required that the two elements to be joined must be directly connected with no intervening material. Id. at * 5. The district court explained that this interpretation does no violence to the open ended nature of the claim resulting from the use of the term "comprising" or the phrase "in proper reading frame." The district court interpreted "comprising" to permit additional material before and after the two required elements, but not in between the two elements that are joined. Id. The district court found that the phrase "in proper reading frame" was not rendered superfluous by requiring the elements to be joined directly because the second element when directly connected is not necessarily in proper reading frame with the first element. For instance, if the second element were connected in reverse orientation or the two elements had overlapping codons, the district court asserts that the two elements would be directly connected, but not in proper reading frame. Id. Based on this reasoning, the district court affirmed the award of priority to Chiron without reaching the utility issue. Genentech appeals this decision of the district court. We reverse.
Genentech asserts on appeal that the district court gave an improperly narrow interpretation to the count; the district court improperly determined a factual issue in dispute, i.e. whether, under 35 U.S.C. § 112, first paragraph, Chiron had enabled the invention of the count as defined by the district court requiring secretion from the yeast cell of mature human IGF-I; and the district court implicitly, but erroneously, upheld the Board's determination that Genentech had provided insufficient proof of the practical utility of its modified IGF-I because Genentech had failed to provide in vivo test results. Because we agree with Genentech that the district court did not give the count its broadest, reasonable interpretation and that Genentech's DNA construct is encompassed by the count, we need not reach the second issue concerning Chiron's enablement of the construct of the count. We also will not reach the utility issue because it was not decided by the district court and is therefore not before us. The sole issue before us is whether the proper construction of the count includes fusion proteins, such as modified IGF-I, or mature human IGF-I.
As Genentech points out, the count calls for a DNA construct which encodes certain proteins, but does...
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