AbbVie Inc. v. Mathilda & Terrance Kennedy Institute of Rheumatology Trust
764 F.3d 1366
| Fed. Cir. | 2014Background
- Kennedy owns the ’766 and ’442 rheumatoid arthritis treatment patents; AbbVie licenses the ’766 patent but not the ’442 patent.
- AbbVie filed suit in the SDNY seeking a declaratory judgment that the ’442 patent is invalid for obviousness-type double patenting over the ’766 patent.
- The district court held claims of the ’442 patent invalid over the ’766 patent after construing key terms.
- Kennedy argues the ’442 patent is patentably distinct as a narrower species with unexpected results, despite overlap with the ’766 patent.
- The court’s analysis connects double patenting policy to second-patent term extension given overlapping subject matter and different expiration dates.
- Ultimately, the court affirms the district court’s invalidity ruling for obviousness-type double patenting.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper construction of co-administration | Kennedy contends broader scope includes antibody-alone after stopping methotrexate. | AbbVie argues co-administration is limited to concomitant/adjunctive modes with methotrexate. | District court construction correct; co-administration covers three modes with both drugs together. |
| Proper construction of active disease | Active disease should be limited to the subset of severe patients per the ’442 specification. | Active disease should be the broader patient population needing treatment. | Assuming Kennedy's construction is correct, still not patentably distinct from the prior patent. |
| Whether the ’442 claims are patentably distinct from the ’766 claims | ’442 is a narrower species with unexpected results not obvious from the ’766. | Species within a genus claimed by the earlier patent can be unpatentable if not patentably distinct. | ’442 is not patentably distinct; obviousness-type double patenting invalidates it. |
| Role of prior-art-like disclosures in double patenting analysis | Disclosures in the reference can be used to assess the claimed species’ unexpected results. | Reference patent disclosure cannot act as prior art against the patentee but may inform obviousness of the later patent. | Disclosed utility may be used to assess obviousness; the ’442 patent’s claimed results were not unexpected. |
Key Cases Cited
- Microsoft Corp. v. i4i Ltd. P'Ship, 131 S. Ct. 2238 (Supreme Court, 2011) (clear and convincing standard for invalidity)
- In re Longi, 759 F.2d 887 (Fed. Cir. 1985) (grounding for double patenting doctrine)
- Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 592 F.3d 1340 (Fed. Cir. 2010) (continuation/URAA context for double patenting policy)
- Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001) (ODP framework; analogous §103 analysis)
- Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1206 (Fed. Cir. 2014) (ODP continues to apply with overlapping expirations)
- Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) (disclosed utility and lack of distinctness for later patent)
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (species not patentably distinct over genus when disclosed)
- In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371 (Fed. Cir. 2008) (disclosed utility used to assess obviousness in double patenting)