271 F. Supp. 3d 358
D. Mass.2017Background
- Oxford Immunotec owns six patents (five in the ’646 family and one ’821 patent) claiming an in vitro IGRA method and kit using ESAT‑6–derived peptides to detect T‑cell IFN‑γ responses for tuberculosis diagnosis.
- Oxford markets T‑SPOT.TB (single standardized tube); Qiagen developed QFT‑Plus (next‑gen QuantiFERON) which includes a single‑tube option similar in purpose and was FDA‑approved for U.S. launch in 2017.
- Oxford sued Qiagen, Quest and LabCorp for patent infringement and moved for a preliminary injunction to bar Qiagen from selling the QFT‑Plus single‑tube option to new customers who use TST or T‑SPOT.TB pending trial.
- The court previously construed disputed claim terms largely in Oxford’s favor and the PTO denied Qiagen’s IPR petitions challenging Oxford’s patents.
- At the preliminary injunction stage the court evaluated likelihood of success (validity and infringement), irreparable harm, balance of equities, and public interest.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Patent eligibility under §101 (and whether claimed peptides are "natural") | Oxford: synthesized peptides are "markedly different" from natural ESAT‑6 and thus patent‑eligible; method claims add inventive combination. | Qiagen: peptides reflect naturally occurring sequences and claims are directed to natural phenomena or conventional steps. | Court: Oxford likely to succeed on §101; synthesized peptides and method viewed as product of human ingenuity, not mere nature. |
| Anticipation/obviousness (§102/§103) | Oxford: prior art does not disclose the claimed combination or motivate the specific invention; PTO rejected Qiagen’s prior‑art arguments. | Qiagen: studies before priority date rendered the claims anticipated or obvious (Melendez‑Herrada, Pathan). | Court: Qiagen failed to raise a substantial question; Oxford likely to prevail against anticipation/obviousness challenges. |
| Written description sufficiency | Oxford: SEQ ID NO:1 and analogues provide a common structural feature and the specification conveys possession. | Qiagen: claim language embraces a genus of peptides without adequate disclosure of which members work. | Court: Oxford likely to satisfy written description; PTO examination supports sufficiency. |
| Irreparable harm / balance of hardships / public interest | Oxford: loss of customers and market share ("sticky" medical customers) would cause irreparable injury not fully compensable by damages. | Qiagen: Oxford delayed seeking relief, can be compensated by money damages; injunction would harm public health and Qiagen’s investments. | Court: Oxford failed to make the required "clear showing" of irreparable harm (delay and quantifiability of monetary harm dispositive); balance of harms slightly favors Oxford but not enough; public interest neutral; injunction denied. |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (two‑step Alice/Mayo framework for patent eligibility)
- Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014) (§101 step‑two "significantly more" inquiry)
- Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (distinguishing patentable synthetic sequences from unpatentable natural products)
- Diamond v. Chakrabarty, 447 U.S. 303 (1980) (human‑made inventions with markedly different characteristics from natural products are patentable)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness standard and caution against hindsight)
- Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008) ("clear showing" of likelihood of irreparable harm required for preliminary injunction)
- Apple Inc. v. Samsung Elecs. Co., 678 F.3d 1314 (Fed. Cir. 2012) (preliminary‑injunction irreparable‑harm standards in patent context)
- Titan Tire Corp. v. Case New Holland, 566 F.3d 1372 (Fed. Cir. 2009) (preliminary injunction; validity not finally resolved at PI stage)