Genentech, Inc.,plaintiff-Appellee v. Chiron Corporation,defendant-Appellant

220 F.3d 1345, 55 U.S.P.Q. 2d (BNA) 1636, 2000 U.S. App. LEXIS 18746, 2000 WL 1091450
CourtCourt of Appeals for the Federal Circuit
DecidedAugust 4, 2000
Docket99-1506
StatusPublished
Cited by9 cases

This text of 220 F.3d 1345 (Genentech, Inc.,plaintiff-Appellee v. Chiron Corporation,defendant-Appellant) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Genentech, Inc.,plaintiff-Appellee v. Chiron Corporation,defendant-Appellant, 220 F.3d 1345, 55 U.S.P.Q. 2d (BNA) 1636, 2000 U.S. App. LEXIS 18746, 2000 WL 1091450 (Fed. Cir. 2000).

Opinion

SCHALL, Circuit Judge.

This appeal stems from an interference between U.S. Patent Application Serial No. 06/506,078 (the “Lee application”), assigned to Genentech, Inc. (“Genentech”), and U.S. Patent Application Serial No. 06/922,199 (the “Barr application”), assigned to Chiron Corporation (“Chiron”). After the Board of Patent Appeals and Interferences (“Board”) awarded priority of invention to Chiron, see Lee v. Barr, Pat. Int. No. 102,208 (July 19, 1994) (Paper No. 176) (“Genentech I”), Genentech brought an action under 35 U.S.C. § 146 in the United States District Court for the Northern District of California. The district court conducted a bench trial, and, in due course, entered judgment in favor of Genentech. 1 See Genentech, Inc. v. Chi *1347 ron Corp., No. CV 94-03334 (N.D. Cal. June 24, 1999) (Amended Judgment). Chi-ron appeals this judgment, challenging the factual findings and legal conclusions of the district court. We reverse. We do so because we hold that Genentech failed to establish that the inventors on the Lee application reduced their invention to practice prior to the earlier effective filing date of the Barr application. Our holding is based on the conclusion that a non-inventor’s recognition of the utility of the invention of the Lee application did not inure to the benefit of the inventors.

BACKGROUND

I.

The subject matter of the interference relates to the recombinant production of human insulin-like growth factor-I (“IGF-I”). IGF-I is a growth-promoting protein. IGF-I works by binding to IGF-I receptors, which are proteins embedded in cell membranes. Binding between IGF-I and IGF-I receptors causes a signal to be transmitted across the cell membrane. This signal activates the intracellular portion of the receptor, which triggers growth-related processes within the cell. The signal is believed to result from a change in the conformation (the three-dimensional shape) of the receptor that occurs when IGF-I binds to the receptor.

Both Genentech and Chiron wanted to use the organism Saccharomyces, commonly known as baker’s yeast, to make IGF-I recombinantly. Yeast makes and secretes a protein known as alpha-factor during its reproductive cycle. When yeast makes alpha-factor, it first makes a precursor protein that comprises a secretory leader sequence and four .repeating units of processing signal sequences and alpha-factor sequences:

leader — processing signal — alpha-factor — processing signal — alpha-factor— processing signal — alpha-factor—processing signal — alpha-factor

The leader sequence is a signal for secretion, i.e., the yeast cell recognizes this sequence and secretes the precursor protein from the cell: Each processing signal sequence in the precursor protein is a recognition site for a proteolytic enzyme— an enzyme that acts at the sequence to cleave (cut) the protein. Thus, when the yeast makes a precursor protein, the precursor is secreted from the cell and cleaved by an enzyme to yield four copies of the mature alpha-factor protein. This is called an expression-secretion system because the yeast expresses the alpha-factor DNA — it makes the precursor protein— and then secretes the protein from the cell. Expression-secretion systems are an advantageous way to make recombinant proteins because the proteins can be recovered without destroying the cells that produce them.

Genentech and Chiron sought to adapt the yeast alpha-factor DNA to make IGF-I. Specifically, they used a DNA construct comprising DNA encoding the alpha-factor secretory leader sequence and the alpha-factor processing signal sequence and DNA encoding IGF-I:

leader — processing signal — IGF-I

When yeast is transformed with this DNA, the yeast first makes a precursor protein comprising the leader sequence, the processing signal sequence and the IGF-I sequence. This protein is then processed by enzymes to cleave the leader and spacer sequences, yielding the mature IGF-I protein.

The interference count defines the invention at issue as follows:

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 sequences.

Genentech I, slip op. at 2. In Genentech II, we construed this count as requiring the following elements: (1) a DNA sequence *1348 coding for the yeast alpha-factor secretory leader sequence; (2) a processing signal sequence; and (3) a DNA sequence coding for IGF-I. See Genentech II, 112 F.3d at 501, 42 USPQ2d at 1613.

The construct that is alleged to support Genentech’s reduction to practice of the count has an additional DNA sequence between the DNA encoding the processing signal sequence and the. DNA encoding IGF-I. See id. at 498, 42 USPQ2d at 1610. That sequence codes for a nine amino acid long collagenase cleavage site. See id. That is, it codes for an amino acid sequence that is cleaved by the enzyme col-lagenase. Thus, the Genentech construct has the following structure:

leader — processing signal — collagenase cleavage site — IGF-I

In Genentech II, we held that the count was broad enough to encompass this construct. See id. at 501, 42 USPQ2d at 1614.

When the Genentech construct is made and processed by the yeast cells, the leader and processing signal sequences are cleaved by the yeast enzymes, but the collagenase cleavage site sequence is not cleaved from the IGF-I sequence. Thus, the final product obtained from yeast transformed with the Genentech DNA construct is a fusion protein consisting of the collagenase cleavage site and the IGF-I sequence. Genentech intended to subject this fusion protein to further processing in order to obtain only the IGF-I sequence (the mature IGF-I protein), but its work in this regard was not successful.

II.

The Board determined the priority of invention to the count in Interference No. 102,208. Because the Barr application had an earlier effective filing date than the Lee application, Barr (Chiron) was the senior party in the interference. See 37 C.F.R. § 1.657(a). Lee (Genentech) therefore had the burden of establishing by a preponderance of the evidence that he had reduced the invention to practice prior to the effective filing date of the Barr application (the “critical date”). 2 See id. § 1.657(b).

The Board determined that Lee had made a construct within the scope of the count. See Genentech I, slip op. at 8. As discussed above, this construct comprised DNA encoding the alpha-factor secretory leader sequence, DNA encoding the alpha-factor processing signal sequence, DNA encoding a collagenase cleavage site, and DNA encoding IGF-I.

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220 F.3d 1345, 55 U.S.P.Q. 2d (BNA) 1636, 2000 U.S. App. LEXIS 18746, 2000 WL 1091450, Counsel Stack Legal Research, https://law.counselstack.com/opinion/genentech-incplaintiff-appellee-v-chiron-cafc-2000.