133 F. Supp. 3d 349
D. Mass.2015Background
- Esoterix owns U.S. Patent No. 7,294,468, claiming a method to predict increased likelihood that gefitinib or erlotinib will be effective for non-small cell lung cancer by detecting specified EGFR exon mutations.
- Qiagen (successor to a licensed party) held a nonexclusive license that distinguished commercial "Licensed Products" from noncommercial "Licensed Research Products;" Esoterix alleges Qiagen sold kits commercially before regulatory approval and beyond the license scope.
- Esoterix sued for patent infringement (Count I), Chapter 93A (Count II), breach of contract (Count III), and breach of the duty of good faith and fair dealing (Count IV).
- Qiagen moved to dismiss under Rule 12(b)(6), arguing the ’468 Patent claims ineligible subject matter under 35 U.S.C. § 101 (laws of nature) and thus Counts II–IV should also fail.
- The court considered the Alice/Mayo two-step § 101 test at the pleadings stage without additional claim construction, treated asserted facts as true, and concluded the patent claims were directed to a natural law and lacked an inventive concept.
- The court dismissed Count I (patent claims) but denied dismissal of Counts II–IV, holding contract and state-law claims can survive a finding of patent ineligibility in these circumstances.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Claim 1 of the ’468 Patent is patent-eligible under § 101 | The claimed method applies a newly discovered correlation (EGFR mutations → drug responsiveness) via conventional testing steps and thus is a patentable application | The claim merely recites a natural law (correlation between naturally occurring mutations and drug efficacy) plus routine, conventional lab steps and is ineligible under Alice/Mayo | Claim 1 (and dependent Claims 2–8) is directed to a law of nature and, absent an inventive concept beyond conventional steps, is § 101 ineligible; Count I dismissed |
| Whether § 101 eligibility requires prior claim construction or factual development | Esoterix argued claim construction/factual development is needed before deciding eligibility | Qiagen argued eligibility can be decided on the pleadings where no substantive factual disputes or claim-construction issues preclude resolution | Court resolved § 101 at the pleadings stage, adopting Esoterix’s favorable constructions and finding no factual issues that precluded a legal determination |
| Whether the presumption of validity / clear-and-convincing standard applies to § 101 challenges at motion to dismiss | Esoterix argued invalidity must be shown by clear and convincing evidence per § 282 | Qiagen contended the presumption/standard is unsettled for § 101 and that eligibility is a question of law appropriate for dismissal | Court declined to resolve the standard, finding it unnecessary: the legal § 101 ruling could be made on the pleadings and by assuming Esoterix’s allegations true |
| Whether state-law claims survive patent invalidity | Esoterix argued breach of contract, Chapter 93A, and good-faith claims stand independently of patent validity | Qiagen argued invalid patent defeats the contract-based claims that enforce a promise not to infringe | Court held contract and ancillary state-law claims may survive patent invalidity where the breach occurred before a licensee challenged validity and where contractual duties are not coextensive with the patent right; Counts II–IV survived dismissal |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012) (establishes that claims directed to natural correlations must include an inventive concept beyond routine steps to be patent-eligible)
- Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (articulates the two-step test for § 101 eligibility)
- Ass'n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013) (natural phenomena and products of nature are not patentable)
- Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371 (Fed. Cir. 2015) (applying Mayo to invalidate claims directed to a naturally occurring biological phenomenon with routine testing steps)
- Studiengesellschaft Kohle, M.B.H. v. Shell Oil Co., 112 F.3d 1561 (Fed. Cir. 1997) (licensee remains contractually liable for royalties/damages incurred before it first challenges patent validity)
- Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat. Ass’n, 776 F.3d 1343 (Fed. Cir. 2014) (§ 101 eligibility is a question of law that can be resolved at the pleadings stage in appropriate cases)