IP Intelligence

IP Intelligence

Insight on Intellectual Property

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

Pharmacy concept

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 laws have introduced greater complexity and higher risk into these strategies. Continue Reading

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

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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 claim construction standard used by the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings, considered by many players in the pharmaceutical industry as posing a significant barrier to protecting intellectual property rights. According to a statistic presented by the petitioners, patent challengers have instituted over 3,400 petitions, resulting in the cancellation of some or all claims in the patent under review in nearly 85 percent of IPR proceedings. Id. at 16. The Supreme Court has also agreed to determine whether the Federal Circuit has the authority to review the Board’s decision to institute an IPR proceeding. Continue Reading

The FTC Weighs In on Big Data

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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 the commercial use of Big Data consisting of consumer information, and its impact on low-income and underserved populations.

The Commission explained:

[This Report] discusses the benefits and risks created by the use of big data analytics; the consumer protection and equal opportunity laws that currently apply to big data; research in the field of big data; and lessons that companies should take from the research. Ultimately, this report is intended to educate businesses on important laws and research that are relevant to big data analysis and provide suggestions aimed at maximizing the benefits and minimizing its risks. Continue Reading

Do Cyber Insurers Care about Information Governance?

Software protection blocking a binary code stream. Digital illustration.

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 risks with cyber insurance.  But companies that also take steps to better manage their information assets not only improve their cyber risk profile; they also put themselves in a better position to secure more favorable cyber insurance coverage terms and rates.  Continue Reading

Artist Richard Prince Sued for Use of Photo from Instagram

ART neon sign bigstockphoto_Art_312547It 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 pieces he displayed during a 2014 installation, described as essentially enlarged screenshots of posts by others to Instagram. They were part of an exhibition entitled “New Portraits” at the Gagosian Gallery in New York City. The pieces appear to be taken wholesale from Instagram accounts with Instagram names, likes, and comments visible. The complaint and its exhibits A and B provide a comparison of the works at issue: artist Donald Graham’s original photograph, “Rastafarian Smoking a Joint,” and the Prince piece (resized for comparison, below). Continue Reading

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

Pharmacy concept

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 carbon-hydrogen (C-H) bonds are replaced with carbon-deuterium (C-D) bonds. (’317 patent, col. 5:61-67) Claim 1 is representative:

1. A compound having the structural formula:

1. a compound having the structural formula

or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 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 with the look and feel of editorial content are ads or that an advertiser otherwise has a material connection to the content.

Just before Christmas last week, the FTC finally issued its long-awaited guidance on native advertising, “Enforcement Policy Statement on Deceptively Formatted Advertisements” (the “Native Ads Policy Statement”). The Native Ads Policy Statement explains how the FTC applies its long-standing consumer protection standards in the native context and how businesses can provide transparency in their native ads to avoid running afoul of the FTC’s antideceptive rules. The Policy Statement reaffirms what we have been advising for years — transparency is necessary to avoid deception, and if consumers are misled regarding commercial messaging, the FTC can prosecute for a violation of Section 5 of the FTC Act, which prohibits false or misleading commercial practices. On the same day, the FTC also issued a supplemental “Native Advertising: A Guide for Businesses,” (the “Native Ads Business Guide”) which provides informal guidance from FTC staff on how to apply the Native Ads Policy Statement in routine digital advertising practices.      Continue Reading

Pandora Enters Into License Agreements With ASCAP and BMI

bigstock-Book-and-tablet-computer-D-mo-26240909Following 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 BMI’s 20 million songs for the next few years. Pandora, ASCAP, and BMI jointly stated that these licenses “allow both ASCAP and BMI to further their goal of delivering improved performance royalties for their songwriters and publishers, while Pandora will benefit from greater rate certainty and the ability to add new flexibility to the company’s product offering over time.” 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 protecting the rights of Internet service providers, their subscribers and rights holders?

BMG asserted that users of Cox’s Internet service employed BitTorrent, a type of peer-to-peer file sharing, to illegally upload and download its copyrighted musical compositions. BMG hired Rightscorp, Inc., to locate infringing uses of BMG’s works. Rightscorp located files allegedly being shared illegally and flooded Cox with 2.5 million DMCA notices. The notices contained a demand that the subscribers pay Rightscorp $10 or $20 per infringement, in addition to removing the content. Continue Reading

Copyright Royalty Board Issues Rate Increase to Pandora

MP3 player sticking out of jean pocket, with earbuds dangling.

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 on nonsubscription services, raising the royalty rate for every 100 songs to 17 cents (up three cents from the current 14 cents per 100 songs). It lowered the royalty rate for subscription services by one cent, down to 22 cents. This is significant for companies like Pandora, where 95 percent of listeners are nonsubscribers. Continue Reading