Federal Circuit Grants U.S. Patent and Trademarks Office Power to Limit Patent Applications
By Sharona Hakimi – Edited by Caitlyn Ross

Tafas v. Doll
Federal Circuit, March 20, 2009, No. 2008-1352
Opinion

On March 20th, the Federal Circuit affirmed in part and vacated in part a decision by the United States District Court for the Eastern District of Virginia in a suit that challenged rules proposed by the U.S. Patent and Trademarks Office (USPTO). Tafas, the plaintiff, contested the USPTO’s proposed rules that limited the number of continuation applications petitioners may file and the number of claims they can include within each application. Judge Prost, writing on behalf of the Federal Circuit, held that the new rules were procedural and thus “within the scope of the USPTO’s rulemaking authority.” However, the case was remanded to determine if the rules should be invalidated on other grounds. The court’s decision confirmed that USPTO does have the power to change its rules and restrict the way patent applications may be filed.

Patent Docs summarizes the case and outlines the Federal Circuit decision. Patently-O highlights and explains the proposed changes to USPTO rules 78 (Continuations), 114 (Requests for Continued Examinations), and 75 and 265 (Claims). Bnet Pharma discusses the potential effect of the decision on drug companies who rely heavily on their ability to patent chemicals. (more…)

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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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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