Companies Seeking to Obtain Biosimilar Product Licenses From the FDA Must Follow the 42 U.S.C. § 262(l)(8)(A) Notice Provision

Amgen Inc. v. Apotex, Inc.

This case involved a dispute over the meaning of the 42 U.S.C. § 262(l)(8)(A) notice provision involving companies seeking to obtain “biosimilar-product” licenses from the FDA.  Amgen successfully obtained a preliminary injunction enjoining Apotex from entering the market unless Apotex gave Amgen notice after receiving the requested FDA license and then waited 180 days. Read more>>

Court Upholds Jury Verdict That Patent Claims Were Not Obvious, But Vacates Denial of Request for Permanent Injunction

WBIP, LLC v. Kohler Co.

WBIP’s patents related to marine engines for use on houseboats that produced reduced amounts of carbon monoxide exhaust.  Elevated amounts of carbon monoxide in engine exhaust is particularly dangerous on houseboats where the exhaust is often close to where occupants are sleeping.  Read more>>

En Banc Federal Circuit Panel Holds that “Sale” of Manufacturing Services to Make a Patented Product Does Not Constitute an Invalidating On Sale Bar

The Medicines Company v. Hospira, Inc.

This case involved product-by-process claims for a form of bivalirudin.  More than one year prior to the filing date of MedCo’s patent applications, it retained a company, Ben Venue, to manufacture three batches of bivalirudin according to the process of the claims.  MedCo paid Ben Venue for manufacturing the drug at an amount that was significantly less than the value of the drug itself.  Read more>>

Federal Circuit Emphasizes That A Coined Term Can Invoke 35 U.S.C. § 112, ¶ 6 Even In The Absence Of The Word “Means”

Advanced Ground Information Systems, Inc. v. Life260, Inc.

The Federal Circuit affirmed the district court’s indefiniteness determination. The district court had found that the terms “symbol generator” and “CPU software” in the asserted claims of U.S. Patent Nos. 7,031,728 and 7,672,681 invoked 35 U.S.C. § 112, ¶ 6, and were indefinite under 35 U.S.C. § 112, ¶ 2.  The Federal Circuit, without deciding whether claim term “CPU software” was indefinite, affirmed the district court’s finding that the term “symbol generator” was indefinite.  Read more>>

Federal Circuit Emphasizes That a Court May Order Arbitration of a Dispute Only Where It is satisfied That the Parties Agreed to Arbitrate That Dispute

Verinata Health, Inc. et al. v. Ariosa Diagnostics, Inc. et al.

Illumina (one of the plaintiffs) sued Ariosa for infringement of its non-invasive prenatal diagnostic test patents, and Ariosa countersued for breach of a supply agreement.  The supply agreement included an arbitration clause and Illumina moved to compel arbitration.   The district court denied Illumina’s motion to compel arbitration.   Read more>>

Federal Circuit Finds That District Court Erred in Finding No Indirect Infringement Based Solely On The Strength of Defendant’s Non-Infringement Arguments

Unwired Planet, LLC v. Apple Inc.

This case involved patents directed to a remote speech recognition system.  The district court construed the claims and, based on those constructions, granted Apple’s summary judgment of non-infringement.  The district court further granted Apple summary judgment of no indirect infringement.  Read more>>

Federal Circuit Holds That an IPR Institution Decision Does Not Shift The Burden of Production To The Patentee

In re: Magnum Oil Tools

The patent-at-issue involved technology in the field of oil drilling through the use of hydraulic fracturing (“fracking”).  The Federal Circuit reversed the PTAB’s final decision finding that all challenged claims of US 8,079,413 were obvious, holding that the Board erred by shifting the burden of production on the issue of obviousness from the petitioner to the patent owner upon the institution of the IPR and by failing to articulate a sufficient rationale for why a skilled artisan would have sought to combine the asserted prior art to achieve the claimed invention.  Read more>>

Federal Circuit Reverses District Court and Finds that Claims Directed to Method of Producing Multi-Preserved Hepatocytes is Not Directed to a Law of Nature and Thus is Patent Eligible

Rapid Litigation Management Ltd. v. CellzDirect, Inc.

The claims-at-issue related to a method of producing a preparation of multi-cryopreserved hepatocytes that are capable of being frozen and thawed at least two times and in which greater than 70% of the hepatocytes are viable after the final thaw.  The claims took advantage of the discovery by the patentees that hepatocytes are capable of surviving multiple freeze-thaw cycles.  Read more>>

Federal Circuit Rules That Purposeful Shipping Of Accused Products To The Forum State May Satisfy The “Minimum Contacts” Requirement For Personal Jurisdiction

Polar Electro Oy v. Amer Sports Winter & Outdoor, et al.

The Federal Circuit vacated the district court’s determination that it lacked personal jurisdiction over a Finnish defendant, Suunto.  Suunto received orders for products from the U.S.; it packaged the ordered products in Finland; and it placed the products on its shipping dock in Finland for a third party shipper to pick up.  Suunto’s U.S.-based sister company, AWSO, paid for the shipping and title to the products passed from Suunto to AWSO at Suunto’s shipping dock in Finland.  Read more>>

Patent Owner Could Not Appeal PTAB’s Claim Construction Where it Prevailed on the Merits of the Reexamination

Skyhawke Technologies, LLC v. Deca International Corporation

Deca requested inter partes reexamination of Skyhawke’s patent.  The Examiner and the PTAB both agreed that Skyhawke’s patent was patentable over Deca’s prior art and arguments.  In so doing, the PTAB construed one of the terms of the claims.  Read more>>