JOLT Digest

Federal Circuit Penalizes ICU Medical, Inc. and Counsel Paul Hastings for Frivolous Patent Infringement Suit
By Jamie Wicks - Edited by Joshua Gruenspecht

ICU Medical, Inc. v. Alaris Medical Systems, Inc.
Federal Circuit, March 13, 2009, No. 2008-1077
Opinion

On March 13^th, the Federal Circuit unanimously affirmed the United States District Court for the Central District of California, which had granted summary judgment in favor of Alaris in a suit in which ICU claimed infringement of its patents for spiked medical valves used in intravenous (IV) fluid transmission. Judge Kimberly A. Moore, writing for the Federal Circuit, granted summary judgment of non-infringement against claims by ICU that the Alaris devices were “spiked” according to the terms of the patents, granted summary judgment of invalidity against claims by ICU that its patents covered spikeless and tubed devices, and awarded $4.6 million in attorney fees to Alaris and Rule 11 sanctions against ICU.

The Patent Prospector summarizes the Federal Circuit’s opinion. Dewipat details the section of the opinion regarding the spiked medical valve claims. Law.com highlights the Rule 11 sanctions, quoting patent attorney Neil Smith, who says that sanctions are “really unusual” in patent cases.

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S.D.N.Y. Determines Family Guy Parody Is Protected by Fair Use
By Leocadie Welling - Edited by Joshua Gruenspecht

Bourne Co. v. Twentieth Century Fox Film Corporation
S.D.N.Y, March 16, 2009, 07 Civ. 8580
Opinion (hosted by Exclusive Rights)

On March 16, 2009, Judge Batts of the Southern District of New York granted summary judgment for the defendants in a copyright infringement suit against the creators, producers and broadcasters of the television series Family Guy. Plaintiff Bourne Co. is the sole owner of the copyright to the popular song “When You Wish Upon a Star.” The plaintiff claimed that defendants had copied “When You Wish Upon a Star” in a “thinly veiled” manner in their song “I Need a Jew,” which appeared in an episode entitled “When You Wish Upon a Weinstein.”

Judge Batts first determined that “I Need a Jew” was parody, not satire, with a correspondingly greater need to borrow from source material. The court then established that the song satisfied the four-prong test for fair use forth set forth by the 1976 Copyright Act, 17 U.S.C. § 107, which, as developed by case law, places emphasis on the purpose and character of the use and the effect of the use on the potential market for the copyrighted content. The court therefore held that the importation of the melody was protected fair use. 

Reuters provides the basic facts. Exclusive Rights offers an overview of the opinion, examining the court’s treatment of the parody versus satire distinction and providing a brief video excerpt of “I Need a Jew.”
Legal Geekery also covers the opinion, characterizing it as a victory for fair use, and comments upon society’s willingness to depend on fair use as a shield against aggressive copyright enforcement. 
The animated film site suite101 hosts an article providing background on the Family Guy spoof from an industry perspective. 

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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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Eli Lilly Granted Stay Extension, Prevents Teva’s Generic Alternative Until March 9th
By Brian Kozlowski - Edited by Anna Lamut

Eli Lilly & Co. v. Teva Pharma
Federal Circuit, February 24, 2009, No. 2009-1071
Opinion

On February 24^th, the Federal Circuit affirmed two to one an order by the United States District Court for the Southern District of Indiana extending the 30-month statutory stay on FDA approval of Teva Pharmaceuticals‘ generic version of Eli Lilly’s postmenopausal osteoporosis drug, Evista®. The stay was extended until March 9, 2009, when trial was set to begin for Lilly’s suit against Teva, in which Lilly alleged that Teva infringed four method patents.  Teva filed for and received an expedited appeal.  Judge Rader, writing for the two-judge majority with Chief Judge Michel, found that Teva “fail[ed] to ‘reasonably cooperate’” in expediting the lawsuit by altering its product last minute and because of multiple delays in producing critical discovery. Controversially, the court based its decision also on allowing Eli Lilly the time to prepare, rather then solely on the factors mandated by the statute.

Patent Docs offers a description of the case’s history, and Patently-O provides a summary of the case.

Patent Baristas notes the importance of even a short stay: Evista accounted for $1.075 billion in sales in 2008, meaning that a two-week extension could mean revenues of $41 million.

Patent Hawk’s Patent Prospector notes surprise at Judge Prost’s dissent, stating that “[f]or a court that regularly takes liberties interpreting the law, Prost strikes a pose as a religious constructionist to statute.”
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Public Trials Should Be Made Available Via Internet
By: Debbie Rosenbaum*
Editorial Policy

File-Sharing Cases in Courts Around the World
In February, the four men behind the popular file-sharing site The Pirate Bay went to trial in Stockholm, Sweden.  They stand accused of helping millions of Internet users illegally download protected movies, music, and computer games. The defendants - Fredrik Neij, Gottfrid Svartholm Warg, Peter Sunde Kolmisoppi, and Carl Lundström - face up to two years in prison and a fine of 1.2 million kronor (US $143,529) if convicted of being accessories and conspiracy to break Swedish copyright law.  The case has made headlines not only because of the substantive legal issues, but also because Defendant Peter Sunde, co-founder of The Pirate Bay, has called for the court’s proceedings to be as open as possible. The Swedish court granted Sunde’s motion to allow coverage of the proceedings without much resistance, and SVT, a public broadcaster in Sweden, has provided streaming audio webcasts webcasts of trial.

A similar situation is unfolding in the United States in a high-profile case involving issues very similar to those of The Pirate Bay case, although here there has been significant resistance for the defendant’s calls to open the proceedings to the public.  Joel Tenenbaum is one of the tens of thousands of defendants being sued by the RIAA for allegedly violating their members’ copyrights by distributing files through P2P file sharing software. However, unlike the vast majority of the defendants in these cases, he chose to litigate rather than settle his case rather than settle, with the help of Harvard Law School Professor Charles Nesson and a team of his students. With Professor Nesson’s assistance, Tenenebaum filed a motion similar to Sunde’s, requesting his trial be broadcast live via the Internet. Tenenbaum’s motion asked the Court to exercise its discretion under the Court’s local rules to allow Internet access to the courtroom by authorizing the Courtroom View Network (”CVN“) to provide audio visual coverage of the proceedings in this case over the Internet.

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