Aria Diagnostics, Inc. v. Sequenom, Inc., 2012-1531

• Decision Date: 16 September 2013
• Docket Number: 2012-1531
• Parties: ARIA DIAGNOSTICS, INC., Plaintiff-Appellee, v. SEQUENOM, INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

ARIA DIAGNOSTICS, INC., Plaintiff-Appellee,
v.
SEQUENOM, INC., Defendant-Appellant.

2012-1531

United States Court of Appeals for the Federal Circuit

Dated: August 9, 2013
Filed: September 16, 2013

Appeal from the United States District Court for the Northern District of California in No. 11-CV-6391, Judge Susan Y. Illston.

JUDGMENT

THIS CAUSE having been heard and considered, it is

ORDERED and ADJUDGED:

VACATED AND REMANDED

ENTERED BY ORDER OF THE COURT

________________________
Daniel E. O'Toole
Clerk

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ARIA DIAGNOSTICS, INC., Plaintiff-Appellee,
v.
SEQUENOM, INC., Defendant-Appellant.
2012-1531

Appeal from the United States District Court for the Northern District of California No. 11-CV-6391, Judge Susan Y. Illston.

DAVID I. GINDLER, Irell & Manella LLP, of Los Angeles, California, argued for plaintiff-appellee. With him on the brief were ANDREI IANCU, AMIR NAINI, LLNA F. SOMAIT and JASON W. SULLIVAN.

MICHAEL J. MALECEK, Kaye Scholer, LLP, of Palo Alto, California, argued for defendant-appellant. With him on the brief were STEPHEN C. HOLMES and JONATHAN M. ROTTER.

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Before RADER, Chief Judge, DYK, and REYNA, Circuit Judges.

RADER, Chief Judge.

Aria Diagnostics, Inc., now known as Ariosa Diagnostics, Inc. (Ariosa) sought a declaration that its Harmony test did not infringe any claim of U.S. Patent No. 6,258,540 (the '540 patent), owned by defendant Isis Innovation Limited (Isis) and licensed by Isis exclusively to Sequenom, Inc. (Sequenom). Sequenom counter-claimed, alleging that Ariosa's Harmony test infringes the '540 patent. The United States District Court for the Northern District of California denied Sequenom's motion for a preliminary injunction to prevent Ariosa from making, using, or selling that test. Aria Diagnostics, Inc. v. Sequenom, Inc., 2012 WL 2599340 (N.D. Cal. July 5, 2012). Because the district court incorrectly interpreted the asserted claims and improperly balanced factors regarding issuance of a preliminary injunction, this court vacates and remands.

I.

Genetically normal human beings have 23 pairs of chromosomes. Having the normal number of chromosomes is called "euploidy." Genetic birth defects often occur when a person has three chromosomes rather than the usual pair. Having an abnormal number of chromosomes is "aneuploidy." Aneuploidy of the three-chromosome variety is called "trisomy." Trisomy causes three major syndromes: Down's, Edwards, and Patau. Down's Syndrome is often caused by trisomy of chromosome 21.

Conventional tests for prenatal abnormalities such as trisomy relied on invasive techniques like amniocentesis to obtain fetal cells floating in the amniotic fluid. Once the fetal cells were removed, the fetal DNA could be analyzed. These invasive tests, of course, presented risks

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to the fetus and the mother. See '540 patent col. 1, ll. 12-17.

As an alternative to invasive techniques, scientists in the 1990's developed methods to determine fetal abnormalities and other fetal traits by analyzing DNA extracted from fetal cells floating in maternal blood. These methods required detecting rare nucleated cells from the fetus that had passed through the amniotic sac into maternal blood, and then extracting and analyzing the fetal DNA in those free floating fetal cells. Among other things, these methods required separating fluids from the cells—and then discarding the fluids, either plasma or serum—and then separating fetal cells from the much more common maternal cells. See id. col. 1, ll. 17-37. Once the cells were separated, the remaining maternal serum or plasma was commonly discarded as waste, and the fetal DNA was extracted and analyzed. J.A. 1118.

The '540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste—the maternal plasma or serum. The '540 patent discloses that non-nucleated free-floating fetal DNA (the cffDNA) exists in maternal blood. See '540 patent col. 2, ll. 1-5. The specification explains that not only does analysis of cffDNA permit more efficient determination of genetic defects (for example, trisomy of chromosome 21) but that a pregnant woman carrying a fetus with certain genetic defects will have more cffDNA in her blood than do women with normal fetuses. Id. col. 3, ll. 30-43. In other words, the '540 patent claims methods to detect fetal genetic characteristics by analyzing cffDNA obtained from a maternal blood sample. These new tests presented fewer risks and a more dependable rate of abnormality detection.

On December 19, 2011, Ariosa filed a declaratory judgment action against Sequenom in the Northern District of California. Ariosa sought clearance to use its

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Harmony test without fear of infringing the '540 patent. On March 8, 2012, Sequenom counterclaimed, alleging that the Harmony test infringes the '540 patent. On that same day, Sequenom moved for a preliminary injunction. On June 29, 2012, the district court heard oral argument on Sequenom's motion. Upon denial of that motion, Sequenom appealed. This court has jurisdiction under 28 U.S.C. § 1292(c)(1).

II.

This court reviews facts for clear error. E.I. Du Pont De Nemours & Co. v. MacDermid Printing Solutions, LLC, 525 F.3d 1353, 1358 (Fed. Cir. 2008). However, to reverse a denial of a preliminary injunction, the appellant "must show not only that one or more of the findings relied on by the district court was clearly erroneous, but also that denial of the injunction amounts to an abuse of the court's discretion upon reversal of the erroneous findings." Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1555 (Fed. Cir. 1994).

The parties dispute the proper standard of review for claim construction in the context of a preliminary injunction. This court recognizes some flexibility on this point. Compare Chamberlain Group, Inc. v. Lear Corp., 516 F.3d 1331, 1340 (Fed. Cir. 2008) ("a correct claim construction is almost always a prerequisite for imposition of a preliminary injunction), with Int'l Cmty. Materials v. Ricoh Co., 108 F.3d 316, 318-19 (Fed. Cir. 1997) ("We do not regard it as our function [in preliminary injunction appeals] to definitively construe" claims or to review claim construction "as if from final judgment").

In this case, the court need not reach out to comment on those alternative approaches to the question. Even under the ostensibly more relaxed standard, the district court erred in its claim construction. As a consequence, the district court erred in finding a substantial question of noninfringement.

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III.

This court first examines the meaning of the phrase "paternally inherited nucleic acid." Claim 1 exemplifies the claims' use of this phrase:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

'540 patent, col. 23, ll. 61-67 (emphases added).

The district court held, at least at this preliminary juncture, that "paternally inherited nucleic acid" means "DNA sequence known [in advance] to be received only from the father which is not possessed by the mother." J.A. 13. The trial court did not use the bracketed "in advance" phrase in its order. The parties agree, however, that the district court's construction requires that the sequence be known "in advance" to have been received only from the father and not possessed by the mother. Under this construction, infringement can only occur after a user knows the father's gene sequence (for example, through genotyping). For reasons that follow, this construction of the phrase is incorrect.

Claim construction focuses primarily on the language of the claims. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). At the outset, the claim language recites only the term "paternally inherited nucleic acid." This term does not incorporate any inherent meaning about the timing or method of detecting the paternal

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characteristic. Rather this claim term states only the origin of that particular nucleic acid however or whenever it may be identified. This language does not require pretesting knowledge of the father's genetic sequence. The phrase "paternally inherited nucleic acid of fetal origin" connotes only nucleic acid that originates from the fetus and is inherited from the father. Had the applicant wanted to limit the claim to those nucleic acids known in advance to have come from the father, it easily could have done so, as the district court's insertion of the "known in advance" requirement shows. The applicant, however, did not limit the term in the claim.

Therefore, to incorporate that requirement into the claim, this limitation must find its source and support elsewhere. The district court attempted to find...