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Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) must do when the applicant refuses discovery that the patent owner needs to … Continue Reading

Regeneron Pharmaceuticals, Inc. v. Merus N.V.: The Federal Circuit Revisits the Defense of Inequitable Conduct

In Regeneron Pharmaceuticals, Inc. v. Merus N.V., No. 2016-1346, slip op. (Fed. Cir. July 27, 2017) (hereafter, “Slip Op.”), the Federal Circuit seems to have loosened the standards for finding a patentee culpable of inequitable conduct during patent prosecution. By affirming the district court’s finding of inequitable conduct, the court in Regeneron condones the use … Continue Reading

Supreme Court Denies Sequenom’s Petition for Certiorari

On June 27, 2016, the U.S. Supreme Court, without comment, denied Sequenom’s petition for certiorari, leaving in place the Court’s previous rulings prohibiting the patenting of laws of nature and natural phenomenon. Sequenom filed its writ of certiorari with the U.S. Supreme Court on March 21, 2016, asking the Court to provide clarification regarding the … Continue Reading

Defend Trade Secrets Act Close to Becoming Law

On April 4, 2016, the Senate unanimously passed the Defend Trade Secrets Act, bringing a federal civil remedy for trade secret misappropriation one step closer to becoming law. House Judiciary Chairman Bob Goodlatte released a statement a few days later saying he planned to move the legislation through the House Judiciary Committee in the coming … Continue Reading

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The petition presents the following questions to the Court: Whether notice of commercial marketing given before FDA approval … Continue Reading

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory and antitrust … Continue Reading

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

Pharmaceutical companies have reason to be pleased with the Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office, No. 15-446 (Cuozzo). The Supreme Court has agreed to review the … Continue Reading

The FTC Weighs In on Big Data

The United States Federal Trade Commission (FTC) has issued a new Report on Big Data, entitled “Big Data:  A Tool for Inclusion or Exclusion? Understanding the Issues,” to provide guidance to companies about their Big Data practices. While acknowledging the numerous issues associated with the use of Big Data, the FTC explicitly limited its focus to … Continue Reading

Do Cyber Insurers Care about Information Governance?

As we welcome in 2016, awareness of the variety of information-related risks confronting today’s enterprises, and the availability of insurance covering those risks, is at an all-time high.  High-profile data breaches caused by hackers and negligent or non-compliant employees, ransomware attacks, and social engineering scams have motivated many companies to transfer some of their cyber … Continue Reading

Artist Richard Prince Sued for Use of Photo from Instagram

It is not the first time artist Richard Prince has made headlines for appropriating others’ artwork into his own without attribution or license. But this time, he has done so in a way that may have implications on the use of photographs posted on social media. He is being sued on one of the 37 … Continue Reading

Patent Trial and Appeal Board Denies Inter Partes Review of Patent Claiming the Deuterated Form of a Known Compound

In Neptune Generics, LLC v. Auspex Pharmaceuticals, Inc., IPR2015-01313, Paper No. 25 (PTAB Dec. 9, 2015) (“Neptune”), the Patent Trial and Appeal Board (“the Board”) issued an opinion denying institution of inter partes review of U.S. Patent No. 7,456,317 B2 (“the ’317 patent”). The ’317 patent claims an analog of venlafaxine (Effexor®) in which nine … Continue Reading

FTC Issues Native Ad Guidance

We have been closely following the evolution of “native advertising” and the regulatory response since before the FTC’s Workshop “Blurred Lines: Advertising or Content?” over two years ago. Applying traditional FTC truth-in-advertising principles, we have recommended how to avoid deception claims by the FTC or the NAD by providing clear and conspicuous disclosure that advertisements … Continue Reading

Pandora Enters Into License Agreements With ASCAP and BMI

Following the Copyright Royalty Board’s ruling to raise Pandora’s royalty rates, last week Pandora announced new licensing agreements with the country’s two largest performing-rights societies, Broadcast Music Inc. and the American Society of Composers, Authors and Publishers. Although the precise terms remain under wraps, these blanket licenses will govern Pandora’s right to play ASCAP’s and … Continue Reading

Greater liability for ISP’s?

In a sure-to-be-appealed verdict last week, a federal court jury in the Eastern District of Virginia found Cox Communications liable to pay $25 million to music publisher BMG Rights Management for contributory copyright infringement. Does this case add anything new to the debate over whether the Digital Millennium Copyright Act strikes the right balance in … Continue Reading

Copyright Royalty Board Issues Rate Increase to Pandora

On December 16, 2015, the Copyright Royalty Board released its much-anticipated ruling, increasing the royalty amount that Pandora and other digital streaming services must pay to stream music in 2016. The CRB’s ruling, which will be released in full after the parties redact confidential information, distinguishes between nonsubscription and subscription services. The CRB cracked down … Continue Reading

Federal Circuit denies en banc review of Ariosa v. Sequenom

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in general.[1] The concurrences and dissent in the Ariosa case offer insight into how the various judges perceive the existing Section … Continue Reading

Obscured by the Cloud? Advanced Instructional Systems and the Scourge of Online IP Theft

The conveniences of cloud computing are many, but so are the dangers of doing business in the cloud. For businesses whose intellectual property is accessible in the cloud, there is the constant threat that that intellectual property will be stolen. There is an increasing belief that the threat of theft is not a nebulous eventuality, … Continue Reading

House Establishes Institute to Formalize its Seven-Year Fight Against Cybercrime

On the fourteenth anniversary of 9-11, H.R. 3490—the Strengthening State and Local Cyber Crime Fighting Act—was introduced in the U.S. House of Representatives. On Monday, November 30, 2015, it passed with an overwhelming majority. The bill establishes the National Computer Forensics Institute (“NCFI”), to be operated by the U.S. Secret Service, to educate law enforcement … Continue Reading

FilmOn and the Copyright Act §111 Compulsory Licensing

Web-based television streaming services have been dealt another blow in their campaign to transmit large broadcasters’ copyrighted programs.  In the latest decision on the issue, a federal judge rejected FilmOn X LLC’s claims that the company could stream protected broadcasts without committing copyright infringement.  Fox Television Stations, Inc. v. FilmOn X LLC, No. 13-758-RMC (D.D.C. … Continue Reading

A New Lenz: Google Weighs In on Fair Use

The Digital Millennium Copyright Act creates a liability “safe harbor” for online service providers that post content that may be protected by copyright. It facilitates the takedown of an infringing work by providing a relatively simple “notice and takedown” procedure. However, the DMCA has been criticized for making it more difficult for individual creators to … Continue Reading

“Are You Serious”

On November 19, at its Rockefeller Center offices, BakerHostetler co-sponsored the pitch event “Are You Serious” along with tech company incubators, The Hatchery and SourcePad. The event was designed to teach entrepreneurs from emerging tech companies how to improve their presentation skills through pitches to a panel of venture capital investors. The evening included presentations … Continue Reading

Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) (“Momenta II”), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), “made” is limited to steps directly related to manufacturing products and excludes isolated quality control steps. The court also revisited its prior … Continue Reading

Fox News LLC v. TVEyes, Inc.—Does the Courts’ Expansion of Fair Use Copyright Protection Promote the “Progress of Science and useful Arts” When It Requires Increasing Judicial Oversight Over Activities That Otherwise Would Be Regulated By the Marketplace?

In 2014, when District Court Judge Alvin Hellerstein of the Southern District of New York upheld TVEyes, Inc.’s (“TVEyes”) monitoring service as “fair use” in the face of a copyright infringement claim brought by Fox New Network LLC (“Fox News”),[1] the decision was seen as yet another step in the federal courts’ limitations of the … Continue Reading

Methods of treating a subset of patients are likely nonobvious if the subset exhibits unexpected results

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.,[1] a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that, although the claims of the patent at issue were invalid as obvious, singling out a particular subset of patients for treatment can still … Continue Reading
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