Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.
689 F.3d 1368
Fed. Cir.2012Background
- Appellants Teva, Barr, and APP appeal a Delaware district court ruling that the ’932 patent is not invalid for obviousness-type double patenting over earlier patents.
- The case concerns regulatory approvals for generic pemetrexed, a TS inhibitor used in cancer treatment; Lilly holds the pemetrexed patents and market exclusivity.
- The district court rejected Teva’s arguments that the ’932 claims were obvious over the ’608 patent’s claim to the ’608 Compound and over the ’775 patent’s claim to the ’775 Intermediate.
- The district court found the ’932 claims to pemetrexed not to be an obvious extension of the earlier claims when considering the claims as a whole and with expert evidence.
- On appeal, Teva contends errors in legal standard and factual findings, while Lilly argues the ’932 claims are patentably distinct.
- The court reviews de novo the ultimate obviousness-type double patenting conclusion, with underlying factual findings reviewed for clear error.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the ’932 patent is obvious-type double patenting over the ’608 Compound | Teva argues use of Amgen standard; differences are only in pemetrexed, so not patentably distinct. | Lilly contends claims must be evaluated as a whole; not merely differences in aryl region. | Not invalid; claims are patentably distinct. |
| Whether the ’932 patent is obvious-type double patenting over the ’775 Intermediate | Teva asserts pemetrexed is an obvious use of the ’775 Intermediate disclosed in the earlier patent. | Lilly maintains two compounds are distinct; prior uses do not render pemetrexed obvious. | Not invalid; two compounds are distinct and the doctrine does not apply here. |
| Whether objective indicia of nonobviousness were properly considered | Teva contends such evidence is irrelevant to double patenting. | Lilly argues secondary considerations should be considered and not categorically excluded. | The district court’s disregard was harmless here, but such evidence should be considered. |
Key Cases Cited
- In re Longi, 759 F.2d 887 (Fed. Cir. 1985) (defines obviousness-type double patenting as preventing extension of patent term)
- Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001) (patentability distinction analysis for double patenting)
- Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) (claims must be considered as a whole in double patenting analysis)
- Gen. Foods Corp. v. Studie ngesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992) (claims must be read as a whole in double patenting analysis)
- In re Avery, 518 F.2d 1228 (CCPA 1975) (uses of earlier patent descriptions in double patenting context)
- Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) (limited use of prior patent specification in double patenting analysis)
- Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) (methods of administration vs. claimed compositions in double patenting)
- Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010) (disclosure of an anticancer use in earlier patent impacts later method claims)
- Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012) (needs motivation to modify earlier compound for double patenting)
- Eli Lilly & Co. v. Teva Parenteral Meds. Inc., 2011 WL 3236037 (D. Del. 2011) (district court decision on double patenting preliminary analysis)