Author Archives: David Rucando

USPTO-Proposed Rule for Recognizing Privileged Communications Between Clients and Non-Attorney Patent Agents and Forgein Patent Practitioners

The United States Patent and Trademark Office (USPTO) published a proposed rule for recognizing privileged communications between clients and non-attorney patent agents and forgein patent practitioners at the Patent Trial and Appeal Board (PTAB).

Link to Federal Register

This new rule, however,  will not affect the duty of disclosure and candor before the Office under 37 CFR 1.56.

The Office is soliciting comments from the public on this proposed rulemaking. Written comments must be received on or before December 19, 2016 to ensure consideration.

 

US Supreme Court Denied Certiorari in Amphastar v. Momenta (No. 15-1402)

The Amphastar case is concerned with the § 271(e)(2) Hatch-Waxman “safe harbor.”

35 U.S.C. § 271(e)(1)  [Hatch-Waxman Act safe harbor] states that it “shall not be an act of infringement to … use … a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs[.]”

Amphastar and others petitioned the Supreme Court on May 17, 2016 presenting the  question: “Whether the safe harbor protects a generic drug manufacturer’s bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be submitted to the FDA upon request.”

The Supreme Court denied Certiorari on October 3, 2016. [Order List]

Amphastar argued that the US Court of Appeals for the Federal Circuit (CAFC) interpreted the Safe Harbor provision of  § 271(e)(1) too narrowly.  The CAFC denied Amphastar safe harbor immunity from Momenta’s patent covering the only approved test for showing bioequivalence of Lovenox.

Amphastar Pharmaceuticals, Inc., et al. v. Momenta Pharmaceuticals, Inc., et al., No. 15-1402

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 http://www.laipla.net/amphastar-v-momenta-supreme-court-denies-certiorari/

Amphastar Argues To Supreme Court: Hatch-Waxman Patent Safe Harbor Is Too Narrow [Lexis Legal News 9/1/2016]

Battle of Lovenox Generics Brought to Supreme Court [Bloomberg BNA 5/20/2016]

Cert. Petition:No. 15-1402 (May 17, 2016)

Panel decision:809 F.3d 610 (Fed. Cir. Nov. 10, 2015)

U.S. Patent:No. No. 7,575,886

 

Amerigen and Alembic petition to join Mylan’s IPR arguing that patent claims covering Toviaz® are obvious over Detrol®

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Amerigen Pharmaceuticals, Ltd and Alembic Pharmaceuticals Limited are challenging the claims of U.S. Patent No. 6,858,650 as being obviousness under 35 U.S.C. § 103(a).  Amerigen and Alembic each filed their own petition and seek to join in the IPR of Mylan Pharmaceuticals, Inc.et al. v. UCB Pharma GmbH, Case IPR2016-00510, which the Patent Trial and Appeal Board (PTAB) has already issued its Decision instituting Inter Partes Review (IPR) in January, 2016. The PTAB said in its decision that UCB Pharma GmbH’s patents, licensed to Pfizer for Toviaz, are likely obvious because the compounds used are too similar to Pfizer’s drug Detrol. TOVIAZ® (fesoterodine fumarate) succeeded DETROL ® (tolterodine tartrate) as the company’s branded incontinence treatment.

Patent at Issue:

U.S. Patent No. 6,858,650 (“Stable salts of novel derivatives of 3,3-diphenylpropylamines,” issued February 22, 2005).

Claim 1: Generic structure for the covered molecules: derivatives of 3,3-diphenylpropylamines

Claims 2-5: Specify the type of compatible acid, specify chirality, and specify substitutions and salt forms.

Claim 5: R-(+)-2-(3-(diisopropylamino- 1-phenylpropyl)-4-hydroxymethyl-phenyliobutyrate ester hydrogen fumarate (commonly referred to as fesoterodine fumarate).

Claims 21-24: recite methods of use.

http://www.patentdocs.org/2016/09/ptab-life-sciences-report-1.html

http://www.law360.com/articles/820997/mylan-wins-ptab-review-of-pfizer-s-toviaz-patents

Janssen’s Remicade Patent Invalid According to Massachusetts Court

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Massachusetts Federal district court ruled that Janssen Biotech, Inc.’s US Patent No. 6,284,471 for Remicade (infliximab) is invalid. Janssen will appeal to the CAFC.

“Janssen loses patent fight over arthritis drug“

“Celltrion, Hospira receive favourable ruling from Massachusetts court on Remicade patent; J&J to appeal“