General Business Intellectual Property Science, Computers & Technology

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En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

Subsequent Employment Agreement Assigning Inventor's Intellectual Property Rights Does not Defeat Standing for Inventions Created...

The plaintiff, Odyssey Wireless ("Odyssey") filed four separate actions for patent infringement against Defendants Apple, Samsung, LG, and Motorola, alleging infringement of U.S. Patent Nos. 7,881,393; 8,199,837; 8,576,940;...more

Where’s My %$^&# Dollar?

The issue of consideration in an assignment is always in the background, but only occasionally comes up. In Memorylink Corp. v. Motorola Solutions, Inc., 773 F.3d 1266, 113 USPQ2d 1088 (Fed. Cir. 2014), the Federal Circuit...more

Security Interest v. License Agreement: Low Tech Precautions for the High Tech Investment

In this exciting age of startups, the market is brimming with opportunities for individuals and entities alike to invest in emerging companies. Today’s rapid rate of technology development justifies investors’ eagerness to...more

Sale of Manufacturing Services Does Not Trigger On Sale Bar Under Pre-AIA §102

In The Medicines Company v. Hospira, Inc., [2014-1469, 2014,1504] (July 11, 2016), the en banc Federal Circuit reversed a panel decision finding that U.S. Patent Nos. 7,582,727 and 7,598,343 were invalid under the on-sale bar...more

Busy Week for Biosimilars Worldwide

United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is...more

ANDA Update - Volume 2, Number 2

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

Patent Law: Making On-Sale Bar Jurisprudence Coherent

“Rather than rest our decision on formalities, our focus is on what makes our on-sale bar jurisprudence coherent: preventing inventors from filing for patents a year or more after the invention has been commercially marketed,...more

Federal Circuit Rules for The Medicines Company in Patent Litigation

In an en banc decision on July 12, 2016 in The Medicines Co. v. Hospira, Inc., the Federal Circuit established the circumstances under which a product manufactured according to product-by-process claims is invalid under the...more

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

Why Should the Automotive Industry Care About Intellectual Property?

With the technological innovation of vehicle safety evolving rapidly, the world just may experience flying and talking cars as seen in the Disney Pixar film Cars. Intellectual property will continue to play an essential role...more

Federal Circuit Clarifies the “Commercial Offer for Sale” Prong of the On-Sale Bar

On July 11, 2016, a unanimous Federal Circuit en banc affirmed that The Medicines Company’s (“TMC”) use of third-party contract manufacturing services did not invalidate U.S. Patent Nos. 7,582,727 and 7,598,343 (the...more

Federal Circuit Limits On-Sale Bar’s Reach

If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

No Sale: Unanimous Federal Circuit Says “Commercial Sale,” Not “Commercial Benefit,” Applies to the Patent Act’s On-Sale Bar for...

On July 11, 2016, in The Medicines Co. v. Hospira, Inc. (Case Nos. 2014-1469, -1504), the en banc Federal Circuit unanimously concluded that “to be ‘on sale’ under § 102(b), a product must be the subject of a commercial sale...more

No Waiver of Forum Selection Clause Despite Filing Declaratory Judgment Action in Non-Selected Forum **WEB ONLY**

Addressing waiver of a contractual forum selection clause, the US Court of Appeals for the Fifth Circuit affirmed a lower court’s enforcement of the clause and subsequent dismissal of a trade secrets case, finding that the...more

EU Court Rules That Royalties for Unpatented Technology Are Not Necessarily Anticompetitive

On 7 July 2016, the Court of Justice of the European Union (CJEU) handed down a judgment on whether Article 101 of the Treaty on the Functioning of the European Union (TFEU) must be interpreted as precluding effect being...more

How to Prepare for Theft of Company Information

Companies should take three steps now to ensure use of the Defend Trade Secrets Act. In May, President Barack Obama signed into law the Defend Trade Secrets Act that creates a federal civil cause of action for the...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Deal Watch: AstraZeneca and LEO Pharma collaborate on skin drugs tralokinumab and brodalumab

AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is...more

Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)

On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No....more

Technology Industry Newsletter - June 2016

For technology companies seeking investment capital, the new SEC regulations on crowdfunding that went into effect on May 16, 2016 present new funding options by expanding the pool of investors beyond the traditional funding...more

Letters from Congress Seek Clarification from USTR Regarding Position on Compulsory Licenses

Last month, we reported on a letter sent by three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination...more

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