Science, Computers & Technology Civil Procedure Intellectual Property

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Supreme Court Reinvigorates Effectiveness of Obtaining an Opinion of Counsel to Defend against Potential Enhanced Damages for...

On June 13, 2016, the U.S. Supreme Court again reversed a decision of the Federal Circuit—the Circuit specially designated to hear all patent appeals—this time, in articulating the test for determining whether to award...more

Software Inventions See More Help in Bascom Decision

Since the Supreme Court decided Alice Corp. v. CLS Bank International, patent examiners and the courts have been working to better define patent eligibility. Following closely on the heels of their Enfish, LLC, v. Microsoft...more

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

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...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

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...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

Recent Decision in Halo Requires Reconsideration of Summary Judgment Motion on Willfulness

In a multi-district litigation, the district court had previously granted summary judgment in favor of the defendants on the issue of willful infringement. After the Supreme Court's decision in Halo Electronics, Inc. v. Pulse...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

I Win? No Fair!

In SkyHawke Technologies, LLC v, Deca International Corp., [2016-1325, 2016,1326] (July 15, 2015), the Federal Circuit granted Deca’s motion to dismiss SkyHawke’s appeal of a PTAB Decision in a reexamination on the grounds...more

A Different Route: Challenging Orange Book Patents Via Inter Partes Review

Since the passage of the America Invents Act (AIA) in 2012, and the corresponding implementation of the inter partes review (IPR) process, patent challengers have been utilizing the Patent Trial and Appeal Board (PTAB) as an...more

Biosimilar “Patent Dance” Does Not Permit Sidestepping of 180-Day Notice

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more

District Court Permits Survey Evidence to Support Lost Profits Damage Theory

The defendants', Roland DGA Corporation and Roland DG Corporation (collectively "Roland"), filed a motion for summary judgment against plaintiff, Gerber Scientific International, Inc. ("Gerber") regarding Gerber's claims for...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

The Defend Trade Secrets Act: Significant Recent Changes to Intellectual Property Law May Provide New Avenues for Protecting...

On May 11, 2016, President Obama signed into law the Defend Trade Secrets Act (“DTSA”), marking one of largest changes to intellectual property law since the America Invents Act of 2011. This legislation will allow companies...more

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

What Type of Sale Constitutes an On-Sale Bar?

An invention cannot be patented if it was ready for patenting and was subject to a commercial offer for sale more than one year before the application was filed. This so-called “on-sale bar” can also be used to invalidate a...more

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...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

Binding Claim Construction Rulings Pre- Teva Vs. Post -Teva

In Teva Pharmaceuticals USA Inc. v. Sandoz Inc., the U.S. Supreme Court held that clear error review applies to factual determinations underlying district court claim constructions. There has been much discussion about the...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

The Medicines Company v. Hospira, Inc. (Fed. Cir. 2016) (en banc)

The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more

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