Shire Development, LLC v. Watson Pharmaceuticals, Inc.
848 F.3d 981
| Fed. Cir. | 2017Background
- Shire sued Watson for patent infringement under U.S. Patent No. 6,773,720, alleging Watson’s ANDA sought approval to market a generic of Shire’s mesalamine product LIALDA® that infringed claims 1 and 3.
- The ’720 patent claims a two-matrix controlled-release mesalamine composition: an inner lipophilic matrix (Markush group listed with “consisting of”) and an outer hydrophilic matrix (separately defined with “consists of”), plus optional excipients.
- Prior Federal Circuit decisions construed the patent to require that each matrix itself exhibit the claimed spatial and compositional characteristics and that the Markush groups limit composition of each matrix.
- At bench trial the district court found infringement, concluding magnesium stearate present in Watson’s outer (extragranular) matrix was irrelevant to the invention because hydrophilic excipients allegedly overwhelmed its effect.
- The Federal Circuit reviewed whether the presence of a lipophilic excipient (magnesium stearate) in the outer hydrophilic matrix violates the claim 1(b) Markush “consisting of” limitation or falls within the Norian “unrelated to the invention” exception.
Issues
| Issue | Plaintiff's Argument (Shire) | Defendant's Argument (Watson) | Held |
|---|---|---|---|
| Whether Watson’s ANDA product meets claim 1(b)’s Markush "consisting of" limitation for the outer hydrophilic matrix | Shire argued the claim-language is closed and magnesium stearate in examples does not expand the closed Markush; the claimed matrices must be hydrophilic/lipophilic as stated | Watson argued its product functions as the claimed hydrophilic outer matrix despite containing magnesium stearate, which is present only as a lubricant and is "unrelated" to the invention | Held: Watson does not satisfy claim 1(b); magnesium stearate in the outer matrix violates the closed "consisting of" Markush limitation |
| Whether the Norian unrelated-component exception applies to excipients present but not intended to serve the claimed matrix function | Shire contended magnesium stearate is related to the invention because it retains lipophilic character and affects function | Watson contended magnesium stearate is unrelated (a nonfunctional lubricant) and thus excluded under Norian | Held: Norian exception does not apply; an excipient that structurally/ functionally relates to the invention cannot be ignored even if introduced for another purpose |
| Whether patent examples disclosing magnesium stearate can overcome the "consisting of" presumption | Shire invoked examples to argue claims should be read to include magnesium stearate | Watson relied on literal claim language to exclude unlisted components | Held: Examples do not overcome the exceptionally strong presumption of a closed Markush created by "consisting of" language |
| Effect on dependent claim 3 given claim 1 noninfringement | Shire argued dependent claim still infringed if 1 is met | Watson argued noninfringement of claim 1 precludes claim 3 infringement | Held: Because claim 1 is not infringed, dependent claim 3 also is not infringed |
Key Cases Cited
- Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359 (Fed. Cir. 2015) (construing matrices as spatially and compositionally distinct and interpreting Markush limits)
- Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350 (Fed. Cir. 2016) ("consisting of" Markush claims create a strong closed-presumption)
- Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir. 2004) (exception allowing unrelated, noninteractive components to be disregarded for infringement)
- Ferring B.V. v. Watson Labs., Inc.-Florida, 764 F.3d 1401 (Fed. Cir. 2014) (one who does not infringe an independent claim cannot infringe a dependent claim)
- CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356 (Fed. Cir. 2007) (distinguishing "comprising" from "consisting of")
- AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239 (Fed. Cir. 2001) (discussing closed claim-element presumption created by "consisting of")