The Medicines Company v. Mylan, Inc.
853 F.3d 1296
| Fed. Cir. | 2017Background
- Medicines Co. owns U.S. Pat. Nos. 7,582,727 (’727) and 7,598,343 (’343), directed to compounded bivalirudin "pharmaceutical batches" with Asp[9]-bivalirudin impurity ≤ ~0.6% and consistent low impurity across batches.
- Mylan filed an ANDA to market generic bivalirudin and certified noninfringement; Medicines sued under §271(e)(2); Mylan counterclaimed invalidity.
- The patents teach that "efficient mixing" of a pH-adjusting solution into a bivalirudin solution prevents local high-pH "hot spots" that produce Asp[9] impurity; Example 4 depicts "inefficient" mixing, Example 5 details an "efficient" protocol (peristaltic pump at 2 L/min, homogenizer 1000–1300 rpm, paddle mixer 300–700 rpm, feed into homogenizer).
- District court construed "batches" per the specification to mean material from a particular compounding process (single batch representative of all commercial batches or all batches from the same process); it construed "efficiently mixing" negatively (not Example 4), granted summary judgment of noninfringement for the ’343 patent, but after trial found the ’727 patent infringed.
- On appeal, the Federal Circuit held the batches limitation requires batch consistency achieved by a compounding process that uses "efficient mixing," and construed "efficient mixing" to require the conditions of Example 5; under that construction Mylan’s ANDA does not infringe.
Issues
| Issue | Plaintiff's Argument (Medicines) | Defendant's Argument (Mylan) | Held |
|---|---|---|---|
| Whether the term "batches" imposes a process/batch-consistency requirement | "Batches" can be satisfied by consistently producing individual batches under 0.6% Asp[9]; no specific process need be claimed | "Batches" as defined in the specification require a compounding process and represent batch consistency across lots | "Batches" requires a compounding process that achieves batch consistency (claims read against spec definition) |
| Whether the asserted claims require "efficient mixing" | Efficient mixing need not be a claim limitation for the product claims; batch impurity result suffices | The specification and prosecution history tie batch consistency to efficient mixing; it is a required process feature | Efficient mixing is required by the batches limitation in both patents; it is a limitation of the asserted claims |
| How to define "efficient mixing" | Define functionally by result (minimizing Asp[9] in compounding solution, e.g., < ~0.6%) | Define by disclosed process steps; rely on Example 5 parameters | "Efficient mixing" is construed to require the specific conditions of Example 5 (peristaltic pump feed, homogenizer high-shear, paddle mixer rates, continuous controlled addition) |
| Whether Mylan's ANDA infringes under the proper construction | Mylan’s specification allows marketing batches within the claimed Asp[9] range, so infringement follows (Sunovion) | ANDA is silent about using Example 5 mixing; Mylan’s disclosed process uses different mixers/technique and thus would not likely make infringing batches | No infringement: Mylan does not use the Example 5 "efficient mixing" conditions; Sunovion inapplicable because ANDA does not establish use of the claimed process |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (specification is primary guide to claim construction)
- Sunovion Pharm., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271 (Fed. Cir. 2013) (ANDA specification can establish infringement when it defines a product meeting claim limitations)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (U.S. 2014) (claims must inform with reasonable certainty those skilled in the art of the scope)
- Ariad Pharm. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (functional claiming cannot claim all solutions to a problem without adequate disclosure)
- Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007) (claim language must be consistent with specification and prosecution history to capture the inventor’s actual invention)