In the first of IBO’s twice annual look at US intellectual property cases among instrument and laboratory product companies, cases related to life science technologies predominate.

Decisions

Wyatt Technology has filed an appeal with the Ninth Circuit Court of Appeals after the US District Court for the Central District of California dismissed its case against Malvern Instruments (see IBO 3/31/08) earlier this year. The suit did not involve patent infringement, but rather copyright violations, among other allegations. The 2007 complaint named Malvern and David Dolak, a Malvern employee. In 2004, Wyatt purchased Proterion’s assets, including those of Protein Solutions (see IBO 11/30/04). The allegations concerned information about Protein Solutions’ DynaPro Dynamic Light Scattering Instrument that Mr. Dolak, a former Proterion employee hired by Malvern, allegedly communicated to Malvern, a competitor of Wyatt’s in the protein-characterization system market. Other allegations in the initial complaint were misappropriation of trade secrets, tortuous interference with prospective business advantage, unfair competition, and violation of the Lantham Act for false and misleading representations.

The case was dismissed following the parties’ stipulation for partial summary judgment in favor of the defendant. The stipulations were in response to the court granting several of the Malvern’s motions in limine, which prevent the submission of evidence in trial that may prejudice a jury. At that time, the court expressed concern about whether there was a sufficient amount of evidence for trial.

Enzo Biochem announced in late March that the Court of Appeals for the Federal Circuit reversed the US District Court for the District of Connecticut’s summary judgment in the company and Yale University’s 2004 patent infringement suit against Applera (Life Technologies) (see IBO 4/30/09). The lower court had ruled that all claims of Yale’s US Patents Nos. 5,328,824 (Methods of using labeled nucleotides), 5,449,767 (Modified polynucleotides and methods of preparing same) and 5,476,928 (Modified nucleotides and polynucleotides and complexes form therefrom) are invalid as either indefinite or anticipated. The lower court had also ruled that Enzo’s US Patent No. 5,082,830 (End labeled nucleotide probe) was not infringed.

The Appeals Court found that US Patents Nos. 5,328,824 and 5,449,767 are valid, but upheld the district court’s ruling as to the other two patents. The case will be remanded to the district court for a new trial. Cases involving Enzo and Affymetrix, PerkinElmer, Roche and Molecular Probes (Life Technologies), among others, had been stayed pending a decision in this case.

Settlement

In March, Caliper Life Sciences settled with Shimadzu, ending its suit against the company for infringement by Shimadzu’s MultiNA System of 11 patents related to microfluidic technology (see IBO 4/30/09). Under the settlement agreement, Shimadzu discontinued the product’s sale in the US, but denied infringement.

New Cases

Earlier this year, Caliper and Stanford University filed suit in the US District Court for the Eastern District of Texas against Carestream Health. The suit alleges infringement of seven patents exclusively licensed to Caliper’s Xenogen subsidiary by Stanford that cover Caliper’s in vivo animal imaging systems.

According to the complaint, the patents concern methods for non-invasive, in vivo optical-imaging of fluorescence and bioluminescence in animals, which Carestream Health’s In-Vivo Molecular Imaging Solutions and Image Station Molecular Imaging Solutions product lines infringe. In its answer to the complaint, Carestream Health denied the allegations and filed counterclaims seeking declaratory judgments of noninfringement and patent invalidity.

In the US District Court for the District of Delaware, GE Healthcare filed suit against Beckman Coulter and its subsidiary, Beckman Coulter Genomics in December 2009, charging infringement of two patents related to technology for isolating and purifying nucleic acids. The complaint alleges that several Beckman kits and reagents based on Agencourt Solid Phase Reversible Immobilization (SPRI) technology, as well as instrumentation used with these kits, including liquid-handling systems, infringe the patents.

Beckman had filed a Request for Reexamination with the US Patent and Trademark Office (PTO). In June 2009, the PTO confirmed the claims of both patents, and denied Beckman’s second Request. In its answer to the complaint, Beckman denied any infringement and filed counterclaims for non-infringement, invalidity and unenforceability.

Cellectricon AB announced in February that it had a complaint against Fluxion Biosciences in the US District Court for the Northern District of California last summer. The suit alleges infringement of three microfluidics patents, including one patent licensed to Cellectricon by Gyros, by Fluxion Biosciences’ Ion Flux automated high-throughput electrophysiology system. Fluxion denies the allegations.

Also last summer, Illumina was named as a defendant in a suit brought by LadaTech, alleging infringement of a patent for DNA amplification by Illumina’s Genome Analyzer and sequencing kits. The suit was filed in the US District Court for the District of Delaware. LadaTech, which is owned by GlaxoSmithKline and IP Finance, announced the suit in a December 2009 press release, stating the patent resulted from work by researchers at Genelabs Technologies. Genelabs Technologies, a biopharmaceutical company, was acquired by GlaxoSmithKline in 2008 for $57 million.

The PTO re-examined the patent in 2008 at the request of a third party on Illumina’s behalf and, according to LadaTech, confirmed the patentability of the claim in 2009. In its answer to the complaint, Illumina denied the allegations and filed counterclaims for unenforceability, invalidation and no infringement, alleging that the patent is unenforceable due to inequitable conduct.

Also in the US District Court for the District of Delaware, Life Technologies is the defendant in a patent infringement suit brought by South Korea’s Boram Pharm The patent was issued to pharmaceutical firm Neurogenex which later merged with Newgex. Newgex was acquired by Boram Pharm in 2009. Boram Pharm alleges that Life Technologies’ Invitrogen BaculoDirect Baculovirus Expression System infringes its patent. Life Technologies has not yet filed an answer.

Selected New US Patent Infringement Cases Among Instrument and Lab Product Companies

Plaintiff: Caliper Life Sciences, Xenogen, and Board of Trustees of Leland Stanford Junior University

Defendant: Carestream Health

US Patent No. and Patent Title:

5,650,135 Non-invasive localization of a light-emitting conjugate in a mammal

7,198,774

6,649,143

6,939,533

6,923,951

6,890,515

6,908,605

Case Filed: 2/23/2010

Plaintiff: Cellectricon AB, Gyros AB

Defendant: Fluxion Biosciences

US Patent No. and Patent Title:

5,376,252 Microfluidic structure and process for its manufacture

7,390,650 System and method for obtaining and maintaining high-resistance seals in patch clamp recordings

7,470,518 Systems and method for rapidly changing the solution environment around sensors

7,563,614

Case Filed: 7/10/2009

Plaintiff: GE Healthcare UK

Defendant: Beckman Coulter, Beckman Coulter Genomics

US Patent No. and Patent Title:

5,523,231 Method to isolate macromolecules using magnetically attractable beads which do not specifically bind the macromolecules

5,681,946 Precipitating polymers

Case Filed: 12/18/2009

Plaintiff: LadaTech

Defendant: Illumina

US Patent No. and Patent Title:

6,107,023 DNA amplification and subtraction techniques

Case Filed: 8/21/2009