Author: Gibbons P.C.

EPA Announces Award of Brownfields Grants

On April 19, EPA announced awards of a total of nearly $80 million in grants to communities across the country to support the assessment, cleanup, and redevelopment of brownfield sites. Twelve of the grants, totalling $2.3 million, will go to New Jersey communities, including Camden, Jersey City, Newark, and Trenton.

Hot News Misappropriation Injunction Issued Against TheFlyOnTheWall.com

In Barclays Capital Inc. v. TheFlyOnTheWall.com, 06 Civ. 4908 (S.D.N.Y. March 18, 2010), Judge Denise Cote issued a narrowly tailored injunction against republication of financial services firms stock recommendations. FlyOnTheWall.com (Fly) collected and published summaries of stock analyst reports within minutes after they were released by financial institutions to their clients. FlyOnTheWall sometimes included summaries of the research reports, but following commencement of the suit it only published headlines such as “EQIX: Equinox initiated with a Buy at BofA/Merrill.” Three financial institutions filed suit against Fly for hot news misappropriation and copyright infringement.

NJ Assembly Passes “Time of Application” Bill

On March 15, 2010, the New Jersey Assembly passed A-437, the “Time of Application” bill, by a vote of 52-15. The bill, which takes effect one year following enactment, provides that those development regulations which are in effect on the date of submission of an application for development shall govern the review of that application for development, and any decision made with regard to that application for development. A-437 now heads to the Governor’s desk.

Assembly Bill Would Bar New Jersey Agencies From Exceeding Federal Standards in Rulemaking

A bill introduced on March 8, 2010, by Assemblyman John J. Burchizelli, and voted out of the Assembly Regulatory Oversight and Gaming Committee would prohibit all State agencies from adopting — or even proposing — regulatory standards tighter than those imposed by the federal government, unless such action is specifically authorized by State law. The measure, Assembly Bill No. 2486, would greatly affect environmental regulation, where federal law often sets nationally applicable requirements, but does not preempt State requirements that go beyond the federal “floor.” The bill does not define the key term “specifically authorized by State law.” It would not apply to regulations in effect on the date of its enactment, or to the readoption of such regulations in the future.

Reed Elsevier v. Muchnick: Copyright Registration is Not a Jurisdictional Requirement

Last week, the Supreme Court issued its highly-anticipated decision in Reed Elsevier v. Muchnick. The decision arose out of a class action settlement between publishers and authors following the Supreme Court’s holding affirming copyright infringement in New York Times, Co. v. Tasini. The Southern District of New York certified the settlement, but the Second Circuit reversed, holding that pursuant to §411(a) of the Copyright Act, the Court lacked subject-matter jurisdiction to approve the settlement because the settlement covered both registered and unregistered works. The Supreme Court reversed, holding that the registration requirement of §411(a) was a claim processing rule and not a jurisdictional requirement. It left open, however, the question of how strictly §411(a) should be applied.

Thunderstorms on the Horizon for Cloud Computing

With the U.S. economy still reeling from the aftershock of what is now known as the “Great Recession,” companies large and small are evaluating cloud computing as a means of reducing IT costs. The National Institute of Standards and Technologies (“NIST”) and the Cloud Security Alliance have defined cloud computing as a model for on-demand network access to a shared pool of computing resources over the internet, namely software applications, data servers, networks and other services. Just as businesses and consumers now pay for gas, electricity and other utilities, cloud enthusiasts predict that the cloud will be sold on demand as a pure IT service.

The Written Description Requirements of 35 U.S.C. §112 and Ariad Pharms. Inc. v. Eli Lilly & Co.

Recently certain members of the patent law bar have expressed surprise that the Federal Circuit has used the written description requirements of 35 U.S.C. §112, first paragraph to invalidate patents such as the University of California’s patent directed to insulin in Regents of the University of California v. Eli Lilly & Co., and Genentech’s patent directed to production of human growth hormone in Genentech, Inc. v. Novo Nordisk A/S. This issue has come to the forefront again in Ariad’s pending per curiam appeal from the Federal Circuit decision in Ariad Pharms., Inc. v. Eli Lilly & Co., vacated and rehearing en banc granted. Oral argument in the case was held on December 7, 2009. In the case under appeal, the Ariad patent was held not to meet the written description requirements of 35 U.S.C. §112, first paragraph.

Biosimilars: Data Exclusivity and the “Patent Protection Gap”

Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor’s drug application relying on the innovator’s data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the “patent protection gap.”