Aptalis Pharmatech, Inc. v. Apotex Inc.
17-1344
| Fed. Cir. | Jan 4, 2018Background
- Aptalis owns U.S. Patents 7,790,199 and 7,829,121 directed to 24-hour extended-release cyclobenzaprine formulations; patents share a common specification.
- The asserted claims require “an extended release coating comprising a water insoluble polymer membrane surrounding said core.”
- Specification discloses two general approaches: (1) membrane systems where a polymer coating is applied onto an active-containing core (ER beads); and (2) matrix systems where polymer is blended with drug and formed into beads.
- Apotex filed an ANDA to market a generic AMRIX product; Aptalis sued for infringement of selected claims of the ’199 and ’121 patents.
- The district court construed “extended release coating” broadly as any layer applied onto a surface to delay drug release, found Apotex’s product infringed, and Apotex appealed.
- The Federal Circuit concluded intrinsic evidence (claims, specification, and prosecution history) supports construing “extended release coating” to require a continuous outer film surrounding the core, vacated the infringement finding, and remanded.
Issues
| Issue | Plaintiff's Argument (Aptalis) | Defendant's Argument (Apotex) | Held |
|---|---|---|---|
| Proper construction of “extended release coating” | Term should be given its plain, broad meaning — any applied layer that delays release (district court’s construction). | Term requires a continuous outer film applied onto the surface of the active-containing core (per specification and prosecution history). | Court adopts Apotex’s construction: “a continuous outer film applied onto the surface of the active-containing core to provide an extended release of the active core.” |
| Whether intrinsic evidence permits reading “continuous” into claims | Argued that adding “continuous” improperly imports limitations not in claim text. | Pointed to repeated specification language describing coatings that surround and are applied onto cores and prosecution declaration explaining film formation. | Court held intrinsic evidence (claims, specification, prosecution history) supports reading “continuous” limitation. |
| Whether construction excludes disclosed embodiments (matrix) | Claimed construction improperly excludes matrix embodiments and preferred examples. | Specification distinguishes coating-based embodiments and matrix embodiment doesn’t negate coating meaning; coating can be applied onto matrix. | Court acknowledged matrix disclosure but found it does not preclude reading coating as continuous outer film; exclusion of some embodiments acceptable. |
| Role of prosecution history without clear disavowal | Aptalis: prosecution history lacks clear and unmistakable disavowal so should not narrow claims. | Apotex: prosecution explanations and declarations inform how skilled artisan would understand the term even without explicit disavowal. | Court held prosecution materials may inform claim meaning even absent explicit disavowal and relied on them here. |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.) (en banc) (claims read in light of specification; ordinary meaning inquiry)
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (review of claim construction may involve intrinsic evidence; factual findings reviewed for clear error)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir.) (specification is highly relevant; cautions against importing limitations from the specification)
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir.) (prosecution history is part of intrinsic evidence and may inform claim meaning)