Barry v. Medtronic, Inc.
245 F. Supp. 3d 793
E.D. Tex.2017Background
- Dr. Mark A. Barry sued Medtronic for indirect infringement of two related patents (the ’358 and ’121 patents) concerning spinal alignment; a jury found infringement, no invalidity, and awarded damages.
- Medtronic counterclaimed inequitable conduct at a subsequent bench trial, alleging (A) false statements/withheld information about Figure 6 (an x‑ray photo) and (B) failure to disclose several prior‑art categories (pre‑critical date surgeries, an IMAST abstract, interactions with device companies, and Dr. Lenke’s alleged prior invention).
- Figure 6 was described in the original specification as showing a patient treated “using the system and method of the present invention,” but during litigation Barry’s counsel disclosed the image derived from an earlier investigational surgery; Barry later sought corrections (Certificate of Correction granted for the ’121 patent, denied by PTAB for the ’358 patent).
- The pre‑critical date surgeries (2002–2004) were presented at trial and the jury found they did not invalidate the patents (the court found substantial evidence supporting that verdict); witnesses described those surgeries as experimental and confidential.
- The court applied Therasense’s two‑part test (specific intent to deceive and but‑for materiality) and required clear and convincing proof of intent and underlying facts; for but‑for materiality the court evaluated patentability under a preponderance standard while still requiring clear and convincing proof of the factual predicates.
- The court concluded Medtronic failed to prove specific intent or but‑for materiality for any theory, denied the inequitable conduct defense, and dismissed the counterclaim with prejudice.
Issues
| Issue | Barry’s Argument (Plaintiff) | Medtronic’s Argument (Defendant) | Held |
|---|---|---|---|
| False description of Figure 6 in specification | Error was inadvertent; corrected when discovered; image did not demonstrate intent to deceive | Figure 6 was misdescribed to support patentability; post‑issuance conduct shows continuing deceit | Court: No specific intent to deceive; not but‑for material; no affirmative egregious misconduct; defense fails |
| Post‑issuance attempts/corrections re Figure 6 (continuing pattern) | Corrections and attempts to notify PTO undermine any inference of deceit | Filing corrections, related continuation, and IPR statements show ongoing deceit and intent | Court: Post‑issuance conduct does not establish a pattern of deceit; PTAB denial of one correction is not proof of bad faith |
| Failure to disclose pre‑critical date surgeries (public use / on‑sale bar) | Surgeries were experimental, confidential, and not reductions to practice; no intent to withhold | Surgeries were public uses or sales that should have been disclosed and were but‑for material | Court: Surgeries were experimental and not but‑for material; no specific intent to deceive; jury verdict of no invalidity reinforced finding |
| Failure to disclose IMAST abstract | If relevant, abstract shows claim limitations but was not viewed by Barry or counsel as material during prosecution | Abstract (Feb 1, 2004) was a printed publication describing the invention and should have been disclosed | Court: Medtronic did not prove the abstract would have defeated patentability or that Barry/counsel knew it was material; no intent established |
| Failure to disclose interactions with device companies & Lenke’s work | Interactions were preliminary/confidential and not offers for sale; no awareness by counsel | Meetings/offers and Lenke’s alleged prior work were prior art that were withheld to deceive PTO | Court: No proof counsel or Barry knew of materiality; interactions not shown to be offers for sale or public disclosures; Lenke theory lacked evidence of Barry’s awareness; no inequitable conduct |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir.) (en banc) (establishes specific intent and but‑for materiality standards for inequitable conduct)
- American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318 (Fed. Cir.) (discusses application of Therasense and materiality proof)
- Intellect Wireless Inc. v. HTC Corp., 732 F.3d 1339 (Fed. Cir.) (post‑issuance conduct may strengthen intent inference in rare cases)
- Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir.) (applies preponderance standard for PTO‑perspective materiality)
- Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir.) (no inequitable conduct where counsel believed statements to be true)
- Hazel‑Atlas Glass Co. v. Hartford‑Empire Co., 322 U.S. 238 (U.S. 1944) (example of affirmative egregious misconduct justifying extreme relief)
- Precision Instrument Mfg. Co. v. Automotive Maintenance Mach. Co., 324 U.S. 806 (U.S. 1945) (fraud on the court and PTO as egregious misconduct)
- Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (U.S. 1933) (bribery/false affidavits as egregious misconduct)
- Trading Technologies Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340 (Fed. Cir.) (experimental uses may not be material prior art)