Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc.
839 F.3d 1111
| Fed. Cir. | 2016Background
- MIT sued Shire for infringement of U.S. Pat. Nos. 5,770,193 and 5,759,830, which claim biodegradable synthetic three‑dimensional scaffolds and methods for growing tissue to produce functional vascularized organ tissue in vivo.
- The patents address prior‑art limits (permanent synthetic matrices and collagen matrices) and the problem of nutrient diffusion that prevented growth of thick, vascularized tissues (cells > ~200–300 microns).
- Shire’s Dermagraft® product uses a bioabsorbable polyglactin mesh seeded with human fibroblasts to produce a living dermal substitute for chronic wounds; MIT asserted this product infringed claims of the ’193 and ’830 patents.
- The prosecution history shows MIT amended and shifted claim language over many years (including attempted “non‑skin” limitations and thickness/300 micron language) in response to prior‑art and §112 rejections; the issued claims ultimately recite scaffolds for producing “functional vascularized organ tissue.”
- The district court construed disputed terms (“vascularized organ tissue,” “cells derived from a vascularized tissue,” and “three‑dimensional scaffold”), found no prosecution disclaimer nor indefiniteness, and after claim construction the parties stipulated to validity and infringement; Shire appealed.
Issues
| Issue | Plaintiff's Argument (MIT) | Defendant's Argument (Shire) | Held |
|---|---|---|---|
| Whether “vascularized organ tissue” excludes skin | Term has ordinary meaning; specification expressly lists skin as an organ within invention scope | Prosecution statements distinguished prior art as limited to thin skin substitutes and thus excluded skin from “organ” | Court: No clear and unmistakable prosecution disclaimer; ordinary meaning controls — term includes skin |
| Whether “cells derived from a vascularized tissue” is limited to parenchymal cells | Ordinary meaning covers cells from vascularized tissue broadly (parenchymal and non‑parenchymal); specification lists non‑parenchymal examples | Prosecution statements (in related filings) show intent to limit to parenchymal cells | Court: No clear disclaimer; claims and specification support broad meaning including non‑parenchymal cells |
| Whether “three‑dimensional scaffold” is indefinite under §112 | Term has ordinary meaning in cell‑culture art (growth on and within a structure); specification and extrinsic dictionaries/experts clarify meaning | Term allegedly gives no guidance; indefinite | Court: Not indefinite under Nautilus; construed as a supporting structure that allows cells to attach along width, length, and height |
| Whether prosecution history disclaimer standard applied correctly; who bears burden | MIT: prosecution history must be read in context of then‑pending claims; isolated statements not dispositive | Shire: multiple prosecution statements demonstrate disclaimer limiting claim scope | Court: The party asserting disclaimer (Shire) bears burden of proving a clear and unmistakable disavowal; Shire failed to meet it |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (standard of review for claim construction: legal conclusions de novo; subsidiary factual findings clear error)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims construed by reference to ordinary meaning to a POSA and the specification)
- Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) (prosecution disclaimer doctrine bars recapturing disclaimed meanings)
- 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315 (Fed. Cir. 2013) (disclaimer must be clear and unmistakable)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014) (indefiniteness standard: claims must inform with reasonable certainty)
- Ecolab, Inc. v. EMC Corp., 569 F.3d 1335 (Fed. Cir. 2009) (prosecution history must be read as a whole; isolated statements may not establish disclaimer)