Category Archives: Case Law

Medgraph v. Medtronic

December 13, 2016

Precedential Opinion today from the U. S. Court of Appeals for the Federal Circuit:

MEDGRAPH, INC. v. MEDTRONIC, INC.; No. 15-2019 (Fed. Cir. Dec. 13, 2016)

The Federal Circuit panel affirmed the District Court’s dismissal of Medgraph’s claims of infringement. Earlier, the Federal Circuit en banc, in Akamai v. Limelight, broadened the law attributing third-party acts to an accused infringer to include occasions when an accused infringer “conditions participation in an activity or receipt of a benefit upon performance of a step or steps” of a claimed method. Rather than remand the case to the district court, the Federal Circuit panel said that Medgraph did not produce facts meeting even the new more broad standard.

Link to CAFC Opinion PDF:
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2019.Opinion.12-9-2016.1.PDF
Link to Finnegan’s Federal Circuit IP blog post:
“Change in Law Does Not Always Compel Remand”

PTAB Upholds Ravicti® Method Claims

The Patent Trial and Appeal Board upheld US Patent 8,642,012  “Methods of Treatment Using AmmoniaScavenging Drugs” owned by Horizon Therapeutics LLC, which claims methods  for treating a patient having a urea cycle disorder using a phenylacetic acid (PAA) prodrug [Glycerol phenylbutyrate (Ravicti®)].  Par Pharmaceutical Inc. and Lupin Ltd. had challenged the claims on obviousness grounds.

PTAB Decision

Claim 1. A method of treating a patient having a urea cycle disorder comprising (a) determining a target urinary phenylacetyl glutamine (PAGN) output (b) calculating an effective initial dosage of phenylacetic acid (PAA) prodrug selected from glyceryl tri-[4phenylbutyrate] (HPN-100) and phenylbutyric acid (PBA) or a pharmaceutically acceptable salt of PBA, wherein the effective dosage of PAA prodrug is calculated based on a mean conversion of PAA prodrug to urinary PAGN of about 60%; and (c) administering the effective initial dosage of PAA prodrug to the patient.

glycerolphenylbutyrate

 

 

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“