Biogen, Inc., Plaintiff-Cross v. Berlex Laboratories, Inc., and Schering Ag

318 F.3d 1132, 65 U.S.P.Q. 2d (BNA) 1809, 2003 U.S. App. LEXIS 1721, 2003 WL 213783
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 31, 2003
Docket01-1058, 01-1059
StatusPublished
Cited by51 cases

This text of 318 F.3d 1132 (Biogen, Inc., Plaintiff-Cross v. Berlex Laboratories, Inc., and Schering Ag) 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.

Bluebook
Biogen, Inc., Plaintiff-Cross v. Berlex Laboratories, Inc., and Schering Ag, 318 F.3d 1132, 65 U.S.P.Q. 2d (BNA) 1809, 2003 U.S. App. LEXIS 1721, 2003 WL 213783 (Fed. Cir. 2003).

Opinions

Opinion for the court filed by Circuit Judge PAULINE NEWMAN.

Concurring opinion filed by Circuit Judge RADER.

PAULINE NEWMAN, Circuit Judge.

In this declaratory action brought by Biogen, Inc., Berlex Laboratories appeals the decision of the United States District Court for the District of Massachusetts, granting Biogen’s motion for summary judgment of non-infringement of United States Patents No. 5,376,567 (the '567 patent) and No. 5,795,779 (the '779 patent). Biogen has filed a conditional cross-appeal on the issue of patent validity.

BACKGROUND

The '567 and '779 patents relate to recombinant DNA technology and the production of human interferon; the conditions of this production form the issues in this litigation. The inventors are Francis P. McCormick and Michael A. Innis of Cetus Corporation, and Gordon M. Rin-gold of Stanford University. Berlex acquired the Cetus rights in 1991.

The principal issue as to the '567 patent is whether certain claims directed to the production of human interferon in Chinese hamster ovary cells were correctly construed as limited to use of a single DNA “construct” to introduce both a selectable [1134]*1134marker gene and the human interferon gene into the host cell. The process whereby a DNA construct (also called a “vector” or “vector construct” or “plasmid”) carrying foreign (called “heterolo-gous”) genes is introduced into and accepted by a host cell is called “transformation” or “transfection.” The process is called “linked co-transformation” when multiple genes are linked in a single DNA construct, and “unlinked co-transformation” when multiple genes are introduced using separate DNA constructs.

The district court observed that integration of heterologous genes is a rare event, typically successful in less than one cell in 100,000, and that it is both difficult and important to detect whether cells have been successfully transformed, as well as to isolate the transformed cells in order to obtain an uncontaminated protein product upon expression of the gene. A selectable marker gene has been used to aid in detecting and isolating transformed cells. In accordance with this procedure, cells lacking a gene that encodes a substance essential to the cell are prepared as host cells, and a DNA construct is prepared to embody the missing gene; then the cells that are successfully transformed with the DNA marker will survive when placed in a medium that is toxic to cells lacking the encoded substance. For the patents in suit, Chinese hamster ovary cells that lack the gene that encodes the enzyme dihydro-folate reductase (DHFR) are used as the host cells.

The patents in suit describe the linked co-transformation of Chinese hamster ovary cells using a single construct carrying both the human interferon gene and the gene for the marker DHFR. In the Biogen process the same genes are used for the same purpose in the same cells, but the interferon gene and the DHFR gene are introduced by separate constructs, that is, by way of unlinked co-transformation. Berlex states that its cell and method claims, correctly construed, literally cover this variation, and alternatively that the construct claims are infringed in terms of the doctrine of equivalents.

I

THE '567 PATENT

The court gives plenary review to interpretation of the scope of patent claims and to the grant of summary judgment based thereon. See Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 46 USPQ2d 1169 (Fed.Cir.1998) (en banc) (claim construction is performed de novo on appeal).

Claims 42, 66, 68, and 70 are representative of the “method” and “cell” claims of the '567 patent, claims that Berlex asserts are not limited to the use of a single DNA construct carrying both the human interferon gene and the marker gene:

42. A method for the production of human interferon in a Chinese hamster ovary cell, comprising growing a Chinese hamster ovary cell having incorporated therein a DNA construct comprising human á- or á-interferon gene, which construct is effective for expression of said human interferon gene, under conditions whereby the interferon gene in said construct is expressed.
66. A Chinese hamster ovary cell having incorporated therein an expressible gene encoding human á- or á-interferon, or a progeny thereof.
68. A Chinese hamster ovary cell having incorporated into its chromosome an expressible gene encoding human interferon, or a progeny thereof.
70. A method of producing human interferon comprising growing a progeny cell of a Chinese hamster ovary cell which has been transformed with an ex[1135]*1135pressible interferon gene and an expressible gene for dihydrofolate reductase, under conditions effective for expression of said human interferon gene.

Of these claims, only claim 70 mentions the dihydrofolate reductase marker gene, and none of these claims mentions the use of a single DNA construct. However, the district court, on review of the specification and the prosecution history, and receiving the testimony of expert witnesses for both sides, construed all the claims as requiring use of a single construct and linked co-transformation with both the interferon and marker genes.

A. Claim Construction

The district court found that the '567 specification discusses only the invention wherein a single DNA construct, linking the interferon gene and the marker gene, is used to introduce the foreign DNA into the Chinese hamster ovary cells, and held that this procedure limits all the claims, including the cell and method claims. Ber-lex argues that the single construct is only a preferred embodiment, and that it is incorrect to limit the claims to the preferred embodiment. The district court, also reviewing the prosecution history, concluded that the asserted broader scope is not warranted.

Berlex argues that the '567 patent includes the larger discovery of the advantageous use of cells of the Chinese hamster ovary to produce human interferon, and that claims 42, 66, 68, and 70 reflect this larger concept. Berlex states that it is irrelevant to the cell and method claims whether transformation of the Chinese hamster ovary cell is achieved by single or multiple constructs, and that these claims are not limited to use of a selectable marker. Berlex states that the specification describes two separate aspects of the invention: 1) the use of Chinese hamster ovary cells to produce high levels of human interferon without expression of the hamster interferon, and 2) the use of a single DNA construct carrying the genes for both human interferon and a selectable marker. Berlex points out that the divisional '567 application was filed after claims specific to the single DNA construct had been allowed in the parent application, now United States Patent No. 4,966,848 (the '843 patent), and that the '567 claims were intended to be, and are, of different scope.

Biogen responds that Berlex’s asserted breadth of the '567 claims is not supported in the specification and that if the claims were interpreted as broadly as Berlex proposes, they would be invalid for lack of an adequate written description. Biogen states that the patent examiner did not view the '567 claims as having the breadth now asserted.

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318 F.3d 1132, 65 U.S.P.Q. 2d (BNA) 1809, 2003 U.S. App. LEXIS 1721, 2003 WL 213783, Counsel Stack Legal Research, https://law.counselstack.com/opinion/biogen-inc-plaintiff-cross-v-berlex-laboratories-inc-and-schering-ag-cafc-2003.