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Whack-a-troll Legislation

Written by Asher Lowenstein     —   Edited by Yaping Zhang

Patent assertion entities’ extensive litigation activities in different states enables to assess the efficacy of the proposed bills against legal strategies these trolls, such as MPHJ Technology, have engaged in. The legal battles confirm some of the concerns about the usefulness of proposed regulatory measures.

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3D Systems and Formlabs Settled Two-Year Patent Dispute

By Yixuan Long – Edited by Yaping Zhang

On December 1, 3D Systems and Formlabs settled their two-year legal dispute over the 520 Patent infringement. Terms of the settlement are undisclosed. The patent covered different parts of the stereolithographic three-dimensional printing process, which uses a laser to cure liquid plastic. 3D Systems was granted the ‘520 Patent in 1997. Formlabs views the settlement as enabling it to continue its expansion and keep developing new products.

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Privacy Concerns in the Sharing Economy: The Case of Uber 

By Sabreena Khalid – Edited by Insue Kim

Recent revelations about Uber’s disconcerting use of personal user information have exposed the numerous weaknesses in Uber’s Privacy Policy. The lack of regulation in the area, coupled with the sensitive nature of personal information gathered by Uber, makes the issue one requiring immediate attention of policy makers.

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San Francisco Court Considers Google’s Search and Ad Services Free Speech

By Jens Frankenreiter – Edited by Henry Thomas

A San Francisco court dismissed a lawsuit against Google, treating Google’s search and advertisement services as constitutionally protected free speech. The lawsuit alleged an antitrust violation based on unfavorable treatment of a website in Google’s search results, and on the withdrawal of third-party advertisement from the website. In throwing out the lawsuit, the court applied California’s “anti-SLAPP” law, which allows quick dismissal of lawsuits against acts protected as free speech.

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EU Unitary Patent System Challenge Unsustainable: Advocate General

By Saukshmya Trichi – Edited by Ashish Bakshi

The Advocate General of the Court of Justice of the European Union has rendered an opinion on Spain’s challenges to regulations implementing the European Unitary Patent System. The Advocate General opines that the challenges must be dismissed as the system is intended to provide genuine benefit in terms of uniformity and integration, and safeguard the principle of legal certainty, while the choice of languages reduces translation costs considerably.

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By Sarah Sorscher*, JD/MPH Candidate, Harvard Law School &
Sara Crager, MD/PhD Candidate, Yale

Editorial Policy

Text of H.R. 1427
Summary

Last week, Rep. Henry Waxman and several other representatives unveiled the latest version of a bill designed to lower the price of drugs by encouraging generic competition in biological products (“biologics”). Biologics are products derived from living processes and used to prevent, treat, or cure human illness. Most drugs, in contrast, are synthesized using chemical reactions.  Biologics include products such as vaccines, blood-derived products, antibodies, and recombinant proteins (e.g. proteins that modulate the immune system, or proteins that induce the proliferation of red blood cells). Over the past 30 years, a revolution in recombinant DNA technology has propelled the sub-field of biologics from the periphery into prominence in the biopharmaceutical industry. Three of the top 10 best-selling drugs in the U.S. in 2007 were biologics (Enbrel, Aransep, and Epogen), and biological products now represent some of the most expensive drugs on the market; annual per-patient treatment costs for one expensive drug topped $300,000 last year.

The new bill, H.R. 1427, dubbed the “Promoting Innovation and Access to Life-Saving Medicines Act,” is intended to introduce price competition in biologics by granting the FDA clear authority to approve generic, or “follow-on” biologics, which are comparable in safety and efficacy to biologics already on the market. The new legislation is modeled on the Hatch-Waxman Act of 1984, which allowed generic manufacturers to gain market approval by showing that their products were interchangeable, or bio-equivalent, with previously approved products, without the need to preform additional clinical trials. Until now, the FDA has been reluctant to allow for this type of abbreviated approval for biologics, which have historically been regulated under a different legal regime from other drugs. Although, as described in this testimony by an FDA official, the story is more complicated. Some proteins that were initially purified from human and animal tissues, such as insulin and human growth hormone, were categorized as drugs when they first obtained FDA market approval. Today these substances remain regulated as drugs, even though they are now synthesized using recombinant DNA technology, like many biologics.
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Posted On Mar - 19 - 2009 Comments Off READ FULL POST

In re Bilski Redefined?
By Briahna Gray – Edited by Anthony Kammer

In re Lewis Ferguson, Darryl Costin and Scott C. Harris
Federal Circuit, March 6, 2009, Serial No. 09/387,823
Order

On March 6, 2009, the Federal Circuit Court of Appeals upheld a ruling by the Board of Patent Appeals and Interferences that a marketing paradigm for multiple independent software companies fashioned by Lewis Ferguson, Darryl Costin, and Scott C. Harris was not patentable under the U.S. Patent Act, 35 U.S.C. § 101.

Judge Gajarsa, writing for the majority, applied the test set forth in In re Bilski opinion from October 30, 2008, which rejected the “useful, concrete and tangible result” test the Federal Circuit had established ten years earlier in State Street v. Signature Financial Group. Judge Newman argued in her concurrence that the majority redefines Bilski and unduly undermines legitimate tests established by precedent, introducing ambiguity into the law.

The authors at Mass Law Blog gave a brief description of the case and applaud the outcome. PatentlyO.com explores the case with commentary. The Digest covered the In re Bilski decision back in October.
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Posted On Mar - 15 - 2009 Comments Off READ FULL POST

Mary J. Blige’s “Family Affair” Not a Copyright Violation
By Jia Ryu – Edited by Anthony Kammer

Jones v. Blige
United States Court of Appeals for the Sixth Circuit, March 9, 2009
Slip Opinion

On March 9, 2009, the US Court of Appeals for the Sixth Circuit affirmed a Michigan district court’s grant of summary judgment for defendant, Mary J. Blige in a copyright infringement case. Plaintiffs Leonard Jones and James E. White had filed suit against Defendants Mary J. Blige, Andre Young (aka “Dr. Dre”), Universal Music Group (“UMG”), and others for copyright infringement.

The Court of Appeals affirmed the lower court’s decision, holding that the songs were not substantially similar and that the Plaintiffs had not provided sufficient evidence to establish Defendants’ access to their work under the “corporate receipt” doctrine. Exclusive Rights offers commentary, focusing on the distinction made in this case between the corporate receipt doctrine and “bare corporate receipt.” The Michigan Messenger briefly summarized the opinion here. (more…)

Posted On Mar - 12 - 2009 Comments Off READ FULL POST

Supreme Court Holds that FDA Regulation Does Not Preempt State Tort Claim
By Caitlyn Ross – Edited by Miriam Weiler

Wyeth v. Levine
Supreme Court of the United States, March 4, 2009, No. 06-1249
Slip Opinion

On March 4th, the Supreme Court of the United States affirmed the judgment of the Vermont Supreme Court, holding that federal drug labeling regulations do not preempt state failure-to-warn lawsuits.  The Supreme Court held that compliance with FDA labeling requirements did not preempt Levine’s failure-to-warn claim based on what she alleged was defective labeling of Wyeth’s anti-nausea drug Phenergan. In so holding, the Court concluded that Congress did not intend to preempt state-law failure-to-warn actions.  It also rejected Wyeth’s claim that the Court should defer to an FDA statement, made in the preamble to a 2006 regulation, that state tort suits threatened the FDA’s statutory mandate.

Briefs and relevant court documents are available here at the SCOTUS wiki.  The SCOTUS Blog provides an overview of the case. Drug and  Device Law Blog suggests that the decision does not eliminate preemption alcims, but does make them far more difficult to win.  The Wall Street Journal Law Blog features an analysis of the decision.  The Volokh Conspiracy notes a decrease in deference to agencies.

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Posted On Mar - 9 - 2009 Comments Off READ FULL POST

Maryland’s Highest Court Adopts Dendrite Standard for Unmasking Anonymous Forum Posters in Defamation Actions
By Evan Kubota –- Edited by Miriam Weiler

Independent Newspapers, Inc. v. Brodie
Court of Appeals of Maryland, February 27, 2009, No. 63
Opinion

On February 27th, the Court of Appeals of Maryland reversed a lower court’s order compelling discovery of the identities of five anonymous Internet forum posters in a defamation action. The court had granted certiorari on its own initiative.  While the court’s holding required it to consider only a pleading issue, it went on to offer guidance to lower courts in future cases involving anonymous Internet speakers in a defamation action.  In doing so, the court adopted the standard from Dendrite International, Inc. v. John Doe No. 3, 775 A.2d 756 (N.J. Super. Ct. App. Div. 2001).

Nixon Peabody’s Digital Media/Internet Law Blog offers analysis of the opinion, concluding that the Dendrite test is “emerging as the leading test across jurisdictions in anonymous Internet speaker cases.”  Ars Technica compares this case to other unsuccessful attempts to uncover the identities of anonymous Internet posters. The Washington Post quotes Paul Alan Levy, a lawyer for the consumer advocacy group that argued the case for Independent Newspapers, who characterizes the opinion as reaffirming the First Amendment right to speak anonymously.

Citizens for Greater Centreville links to the oral arguments and appellate brief in the case.

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Posted On Mar - 6 - 2009 Comments Off READ FULL POST
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