Supreme Court Rewrites the Law of Enhanced Damages

This is a guest post by Janice M. Mueller of Chisum Patent Academy.

Today the Supreme Court rewrote the law of enhanced damages for willful patent infringement by issuing a unanimous decision in No. 14-1513, Halo Elecs., Inc. v. Pulse Elecs., Inc., 2016 WL 3221515 (U.S. June 13, 2016), and the companion case, No. 14-1520, Stryker Corp. v. Zimmer, Inc., 2016 WL 3221515 (June 13, 2016). Swept away as “unduly rigid,” “inelastic,” impermissibly encumbering” district courts’ discretion, an “artificial construct,” and simply inconsistent with the text of 35 U.S.C. 284, the Federal Circuit’s elaborate framework for determining whether infringement damages should be enhanced (and reviewing such determinations on appeal), as set forth in In re Seagate Tech. LLC, 479 F.3d 1360 (Fed. Cir. 2007) (en banc) and Bard Peripheral Vascular, Inc. v. W.L. Gor & Assoc., Inc., 682 F.3d 1003 (Fed. Cir. 2012), is no longer good law.

You can read the entire post here.

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Merck’s Solvaldi® Patents Unenforceable for Egregious Misconduct

In Gilead Sciences, Inc. v. Merck & Co., Inc., Case No. 13-cv-04057-BLE (N.D. Cal., June 6, 2016), Judge Beth Freeman, sitting in equity, found that the record compelled a finding that Merck and its employee “D” had obtained asserted patents 7,105,499 and 8,481,712 after using inequitable conduct. Earlier, the jury had found the patents valid and awarded Merck $200 million in damages for infringement  of this costly drug, that contains the active ingredient sofosbuvir or solvaldi.

Her 65 page order (a copy along is available at the end of this post) rests on the Fed. Cir.’s Therasense decision, which redefined inequitable conduct (“IC”). While most inequitable conduct charges are based on a failure of the patentee to disclose material prior art to the PTO, the court reaffirmed other bad behavior, not necessarily involving prior art:

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Due May 24 — Comments On Improving Patent Quality Metrics

iStock_000072606049_SmallMany patent attorneys received a notice recently, copied below, alerting them to efforts by the US Patent Office to improve patent quality.

The notice references a “Master Review Form”. A preliminary version can be found at:
http://www.uspto.gov/sites/default/files/documents/MRF.pdf

Not only does this Form serve as a “checklist” for how examiners are supposed to process your application, it provides an indication of how prosecution will be graded by the Office.

Once the Form is finalized, you can use it to fortify your responses, so that when you find something missing in an Office Action, you can explicitly point out how the Examiner has failed to properly address certain aspects of the rejection.

If you are able to promote the missing content as a significant deficiency, noted as such in bold type in the response, and using the same words that are on the Form, you might just get a second chance at allowance.
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New (and Improved?) PTO Guidelines on Biotech Patent-Eligibility

The PTO has released a new set of life sciences’ examples to teach Examiners how and when to reject claims and, hopefully, teach the patent bar how to write allowable claims. (A copy if found at the end of this post.)

The Guidelines have examples on vaccines, diagnostics, methods of medical treatment and BRCA-type Myriad claims. There are some surprises. Although Ariosa was decided about a year ago, the Guidelines approve of a claim to detecting a marker indicative of a certain disease by detecting whether the marker is present when a plasma sample is contacted with an anti-JUL-1 antibody and detecting any binding (e.g., an ELISA-type assay). The Guidelines justify this position by noting that the steps do not recite any recognized exceptions to s. 101, citing Mayo. This hypothetical claim could have come from Ariosa, which the Office must have made a hard decision to ignore.

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