Monthly Archives: October 2010

Copyright Principles Project/Center for Democracy and Technology Copyright Reform

Posted on October 17, 2010 by Musetta Durkee under The Bolt

Current copyright law has proven inadequate to address the uses of creative works in this technological and Internet age. Today’s global environment is one of almost costless reproducibility and dissemination, low-cost production of not only written works but also musical, visual, and moving image works, and increased and varied platforms for publication. In addition, the past decade has seen proliferation of user-generated content, in which both amateurs and professionals enjoy copyright ownership over their publicly accessible works, as well as an unfailing use of peer-to-peer file sharing of copyrighted works. Combine these developments in creation and dissemination of copyrightable works with the complicated role of online service providers (OSPs) as hosts of both amateur and professional content and copyright law can be fairly described as “under considerable stress.”

This is how Pamela Samuelson and Members of the Copyright Principles Project (CPP) summarized the current state of copyright law in the recently released “The Copyright Principles Project: Directions of Reform” (PDF). In the Report, Samuelson and CPP outline seven guiding principles for copyright reform, focusing on the purpose of copyright in this digitally interconnected world. Copyright should:

1)   “encourage and support the creation, dissemination, and enjoyment of works of authorship in order to promote growth and exchange of knowledge and culture”;

2)   “promote the creation and dissemination of new works in three distinct and complimentary ways: by encouraging the provision of capital and organization needed for the creation and dissemination of creative works; by promising creators opportunities to convey their works, as appropriate, to aid education, cultural participation, the creation of new works, and the development of new forms of creative output”;

3)   “facilitate the provision of capital and organization for creative works by providing a set of rights over which parties can reliably transact”;

4)   “give creators opportunities to convey works to their intended audiences by vesting exclusive rights, as an initial matter, in the authors of the works and encouraging authors to explore different ways of reaching audiences for the works”;

5)   “limit control over uses of creative works by setting boundaries on the rights of copyright owners and on remedies for infringement”;

6)   “support opportunities for innovation and competition in technologies for disseminating and experiencing creative works” and “also support rights holders’ reasonable interests in effective protection of their rights in the face of technological change”; and

7)   “recognize that the system in which creative activity occurs and in which creative works are circulated is increasingly global.” Continue reading →

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Solicitor General Files Brief in Stanford v. Roche

Posted on October 17, 2010 by Robert Yeh under The Bolt

On September 28, 2010, the Solicitor General (SG) filed a brief explaining the views of the United States in the pending appeal of Stanford v. Roche, 583 F.3d 832 (Fed. Cir. 2009) (PDF).  The SG’s brief argues strongly in Stanford’s favor, and urges the Supreme Court to grant Stanford’s petition for a writ of certiorari.  This post is focused on the SG’s brief.

Fact Summary

The ownership of three patents is in dispute.  All three patents share a common parent application and claim a method for quantifying Human Immunodeficiency Virus (HIV) in human blood samples using polymerase chain reaction (PCR).  In 1988, Holodniy, one of the listed inventors on the patents, began working at Stanford University as a Research Fellow.  Upon joining Stanford, Holodniy executed an agreement to assign future inventions to Stanford. Cetus is a biotechnology company that pioneered PCR techniques for medical diagnostics, and is the predecessor of Roche in this dispute.  In early 1989, Holodniy began conducting research at both Stanford and Cetus.  Before beginning his work with Cetus, Holodniy executed an assignment agreement to immediately assign all future inventions to Cetus.  In due course, Holodniy’s research with Cetus produced a PCR assay that could quantify HIV in humans, and Stanford filed the patent application that would become the parent application from which the patents-in-suit claim priority.  Because the HIV research at Stanford had been funded by National Institutes of Health (NIH), Stanford “formally notified the Government that it elected to retain title to the inventions under the Bayh-Dole Act” during prosecution of the patents-in-suit.  Stanford is the named assignee of all three patents-in-suit.  Upon failure to reach a licensing agreement with Roche on the PCR assay for HIV, Stanford filed suit in 2005 against Roche for infringement.  Roche answered and counterclaimed that Stanford lacked standing to bring suit because Roche “possesses ownership, licenses, and/or shop rights to the patents through Roche’s acquisition of Cetus’s PCR assets.”  Roche also answered that the asserted patent claims were invalid for obviousness.

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Teva v. Eisai: Subsequent Paragraph IV Filers Have Standing When Commencement of First-Filer’s Exclusivity Period is Delayed

Posted on October 14, 2010 by Lily Ackerman under The Bolt

In Teva v. Eisai, the Federal Circuit held that a subsequent Paragraph IV filer has standing when a patent listed in the Orange Book causes a delay in the triggering of a first filer’s exclusivity period and prevents the subsequent filer from bringing a generic drug to market.

The Hatch-Waxman Act grants a generic drug-maker 180 days market exclusivity when the drug-maker files an “Abbreviated New Drug Application” (ANDA) and a “Paragraph IV” certification for a drug covered by a patent listed in the Orange Book.  After the first-filer’s exclusivity period ends, subsequent Paragraph IV filers may also market the generic drug.  Under 21 U.S.C. § 355(j)(5)(B)(iv), two events may trigger the exclusivity period, whichever occurs first:  (1) the first-filer commercially markets the generic drug, or (2) a court finds that the patent listed in the Orange Book is invalid or not infringed.

Eisai has FDA approval of its New Drug Application (NDA) for donepezil, a drug used to treat dementia in Alzheimer’s disease patients.  Five Eisai patents listed in the Orange Book cover donepezil.  Ranbaxy was the first to file an ANDA for generic donepezil.  For one of the five Eisai patents, the ’841 patent, Ranbaxy filed a Paragraph III certification which restricts Ranbaxy from marketing a generic of donepezil until the ’841 patent expires.  Of the remaining four patents, Ranbaxy filed Paragraph IV certifications which indicate that Ranbaxy believes its drug does not infringe the patents or the patents are invalid.

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Goeddel v. Sugano – Disclosure that Allows a PHOSITA to “Envision” an Invention Fails the Written Description Requirement

Posted on October 2, 2010 by Robert Yeh under The Bolt

The recent decision in Goeddel v. Sugano concerns an appeal from an interference proceeding.  Although these types of cases may be a “dying breed” if patent reform goes through (as discussed in this PLI Patent Law Practice Center post), this case highlights written description requirement issues that are relevant outside of the interference context.  Specifically, Goeddel underscores the differing standards of sufficiency when examining a patent application from the written description requirement perspective, versus viewing a patent application as a piece of prior art for non-obviousness determination against another patent application.  The holding here would seem to imply that a prior patent application that can likely render a contested invention obvious and not patentable may nevertheless fail the written description requirement itself, and thus face a 35 U.S.C. § 112 rejection.

The scientific basis of this case can be summarized as follows.  Mature Human Fibroblast Interferon (hFIF) comprises 166 amino acids, but is encoded in a native 187 amino acid precursor form that undergoes post translational cleavage of 21 amino acids in vivo.  Both parties are interested in patenting the process of creating recombinant forms of mature hFIF.  In essence, the contested species is the truncated DNA sequence corresponding to the 166 amino acid mature hFIF (mature form), rather than the full sequence corresponding to the 187 amino acid precursor (precursor form).

Sugano’s Japanese application disclosed the precursor form of hFIF, but did not describe the mature form, or the process of transforming the precursor to the mature form.  The patent office and BPAI gave Sugano priority in his US application, relying on Sugano’s earlier Japanese application as evidence of constructive reduction to practice.  The Federal Circuit reversed BPAI’s decision, and awarded priority to Goeddel based on Sugano’s failure to meet the written description requirement.  In particular, the court found that Sugano’s original Japanese application does not sufficiently demonstrate constructive reduction to practice to satisfy the written description requirement of 35 U.S.C. § 112, first paragraph.

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Georgia-Pacific Contributory Trademark Infringement Claim Fails in Eight Circuit

Posted on October 2, 2010 by Margaret Grazzini under The Bolt

The Eight Circuit affirmed summary judgment for Myers Supply Inc. against Georgia-Pacific Consumer Products LP (“G-P”) on the issues of contributory trademark infringement and tortious interference with contract where Myers sold von Drehle (“VD”) paper towels for use in G-P machines to a church and school district. Georgia-Pac. Consumer Prods., LP v. Myers Supply Inc., No. 09-2980 (8th Cir. filed Sep. 15, 2010) (PDF).  G-P leases automatic paper towel dispensers and produces non-universal paper towels of fabric quality with which to load the machines.  In fact, the G-P licenses require the distributor and end-users to use the branded paper towels. The Myers court considered the 4th Circuit decision to vacate summary judgment on similar issues regarding VD’s production and sale of inferior paper towels intended for use solely in the G-P branded dispenser, but distinguished the decision.  Georgia-Pac. Consumer Prods., LP v. Von Drehle Corp., No. 09-1942 (4th Cir. Aug. 10, 2010) (PDF).

In Myers, the court required that G-P show that these inferior paper towels loaded into the G-P dispensers were likely to confuse restroom patrons as to the source of the paper towel to satisfy the Lanham Act’s standard for infringement. See 15 U.S.C. § 1125(a)(1)(A). The Fourth Circuit, however, determined that there is “room for the factfinder [sic] to consider confusion among the non-purchasing public in the likelihood-of-confusion inquiry if it can ‘be shown that public confusion will adversely affect the plaintiff’s ability to control his reputation among its laborers, lenders, investors, or other group with whom plaintiff interacts.’” The Eighth Circuit distinguished this holding because the Fourth Circuit did not necessarily conclude that there was confusion among the post-purchase patrons, just that, as a matter of law, the district court should have considered that audience’s likelihood of confusion.

VD is a manufacturer and seller of sub-par paper towels, and did not themselves load the product into the G-P branded dispensers.  As such, a direct trademark infringement claim was not available to G-P.  Instead, G-P argued that VD’s sale of an inferior a paper towel and promotion of “stuffing” the G-P dispensers with the VD paper product amounted to “contributory trademark infringement in violation of § 32 of the Lanham Act, 15 U.S.C. § 1114(1).” As “the tests for trademark infringement and unfair competition under the Lanham Act are essentially the same as that for common law unfair competition under North Carolina common law,” the court focused on “the likelihood of confusion as to the source of the goods involved.”

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