Aria Diagnostics, Inc. v. Sequenom, Inc.
726 F.3d 1296
| Fed. Cir. | 2013Background
- Ariosa seeks declaratory judgment that its Harmony test does not infringe the ’540 patent owned by Isis and licensed to Sequenom.
- Sequenom counterclaims alleging infringement; district court denied Sequenom’s preliminary injunction.
- This court vacates and remands due to erroneous claim construction and improper balance of injunction factors.
- The asserted claims use the term “paternally inherited nucleic acid” found in fetal DNA analysis from maternal blood.
- Key issues involve interpretation of what “paternally inherited” and “amplifying” mean, and whether earlier prosecution statements limit claim scope.
- On remand, district court should address subject matter eligibility in light of Myriad and reconsider equitable factors for injunction.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Meaning of paternally inherited nucleic acid | Ariosa: no advance-knowledge limitation; covers any paternal DNA not in the mother. | Sequenom: requires knowledge in advance that paternal DNA is present and distinguishable. | District court erred; no known-in-advance limitation. |
| Meaning of amplifying | Ariosa: amplifying refers to increasing paternal DNA relative to all DNA, not requiring change in other DNA. | Sequenom: amplifying means increasing the proportion of paternal DNA in the sample. | District court erred; correct meaning does not require proportion change. |
| Substantial question of infringement | Ariosa contends proper construction shows no infringement. | Sequenom argues proper construction supports noninfringement. | Court reverses district court on construction; substantial question not shown. |
| Subject matter eligibility after Myriad | Ariosa asserts Myriad’s framework should be applied on remand. | Sequenom argues patent-eligibility remains in question. | Remand to address eligibility in light of Myriad; no final ruling now. |
| Equitable factors for injunction on remand | Sequenom argues irreparable harm and public interest favor protection. | Ariosa contends potential public harm from delaying testing. | Remand to reconsider traditional injunction factors with updated record. |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim construction focused on claim language)
- Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012) (limiting claim terms requires clear intention or disavowal)
- Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004) (no implied limitation from a single embodiment without clear intent)
- Reebok Int’l Ltd. v. J. Baker, Inc., 32 F.3d 1552 (Fed. Cir. 1994) (standard for altering claim scope in appeals of injunctions)
- Pfizer, Inc. v. Teva Pharm. USA, Inc., 429 F.3d 1364 (Fed. Cir. 2005) (irreparable harm considerations in injunctions)
- Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (U.S. 2013) (Myriad decision on patent-eligibility of isolated DNA)