IP News

Dosage Suggestion Need Not Teach Efficacy to Render Dosage Claim Obvious

On June 22, 2011, the Federal Circuit delivered its opinion in Tyco Healthcare LP v. Mutual Pharm. Co., Inc., No. 2010-1513, which involved claims 1 and 2 of U.S. Patent No. 5,211,954, (“the '954 patent”). These claims cover formulations of the sleep-inducing drug temazepam, and were identical, except that claim 1 claims capsules containing 6 to 8 mg of temazepam, while claim 2 claims 7.5 mg capsules. The '954 patent issued on May 18, 1993 with a priority date of Sept. 23, 1986.

In November 2006, Mutual Pharmaceutical Company, Inc. (“Mutual”) filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to manufacture and sell a generic version of the 7.5 mg temazepam capsules. Tyco responded by filing an infringement lawsuit, and when Mutual received tentative FDA approval for its ANDA, Tyco moved for a preliminary injunction to block Mutual from selling generic temazepam.

At trial, the district court denied Tyco's preliminary injunction motion, and granted Mutual's motion for summary judgment of invalidity, concluding that the '954 claims were obvious. In reaching that conclusion, the court relied primarily on three facts. First, capsules containing 15 and 30 mg dosages of temazepam, but otherwise identical to those claimed in the '954 patent, had been sold in the United States more than one year before the patent's priority date. Second, a 1983 volume of the British National Formulary (“BNF”) disclosed using dosages of temazepam of 5 to 15 mg for the treatment of insomnia in the elderly. Third, neither party disputed the maxim that “physicians always seek to prescribe the lowest effective does of any medication, particularly hypnotics such as temazepam.” These three undisputed facts led the district court to conclude that it would have been obvious to anyone of ordinary skill in the art to combine the pre-existing 15 mg temazepam capsule with the dosage range identified in the BNF reference. Tyco appealed.

A panel of the Federal Circuit affirmed the district court's ruling and held that the BNF reference, combined with the pre-existing temazepam capsules, would have been sufficient to render a 7.5 mg capsule obvious. The court was unpersuaded by Tyco's argument that the BNF prior art did not provide any evidence or discussion of the efficacy of lower dosages of temazepam, because the claims of the '954 patent had no efficacy limitations. The Federal Circuit also found Tyco's arguments of teaching away, unexpected results, and commercial success unavailing.

Eighth Circuit Limits Use of Uncopyrighted Promotional Material for Copyrighted Films

On July 5, 2011, a panel of the Eighth Circuit Court of Appeals, consisting of Judges Raymond W. Gruender, Duane Benton, and Bobby E. Shepherd, issued a unanimous opinion, authored by Judge Gruender, in Warner Bros. Entertainment Inc. et al. v. X One X Productions et al., No. 10-1743. In Warner Bros., the Eighth Circuit was called upon to review the lower court's finding that a group of defendants infringed Warner Bros.' copyright in several films when they sold images extracted from publicity materials for those films. The panel held that, while the particular publicity images were in the public domain, the defendants could not combine extracted images together, or with text, or use them to create figurines, without infringing on Warner Bros.' copyrights in the respective films.

Warner Bros. owns the copyright to the 1939 films “The Wizard of Oz,” and “Gone with the Wind,” as well as several short Tom & Jerry cartoon films that debuted between 1940 and 1957. Before the films were completed and copyrighted, publicity materials featuring images of the actors in costume were distributed to theaters and published in newspapers and magazines. The images in the publicity materials consisted of photographs taken before or during production of the films, or, in the case of the cartoons, independently drawn images, and were not taken from footage used in the films. The publicity materials did not comply with the copyright notice requirements of the 1909 Copyright Act, 17 U.S.C. ” 1 et seq., which was in effect during the relevant period, and Warner Bros. conceded that it had no registered copyright in the publicity materials themselves.

Defendants A.V.E.L.A.., Inc., X One X Productions, and Art-Nostalgia.com, Inc. (collectively, “AVELA”) acquired restored versions of the promotional material and extracted images of famous characters, including Dorothy, Tin Man, Scarlett O'Hara, Tom and Jerry, and licensed the images for use on items such as shirts, and lunchboxes, and as models for three-dimensional figurines. AVELA often modified the images by adding the character's signature phrase from the movie, or combining extracted images from different publicity materials into a single product.

Warner Bros. sued AVELA for copyright infringement. The district court determined that, regardless of whether the publicity materials were in the public domain, AVELA's practice of modifying the extracted images infringed the film's copyright. Warner Bros. averred that it would not assert the copyrights against unaltered reproductions of the individual items of publicity material, which eliminated any need for the district court to resolve whether the publicity materials were in the public domain. Based on its findings, the district court entered a permanent injunction barring all use of the publicity material beyond exact duplication of the individual items, which AVELA appealed.

On appeal, the Eighth Circuit panel determined that it was necessary to decide if, and to what extent, the publicity images were in the public domain. The panel determined that the images were in the public domain because they had been distributed to theaters without the statutorily required notice, and were not subject to the limited publication exception. In doing so, the Eighth Circuit adopted the framework for limited publication developed by the Ninth Circuit, as articulated in White v. Kimmel, 193 F.2d 744, 746-47 (9th Cir. 1952), which requires limited distribution be to a definitely selected class of persons without the right of reproduction, distribution, or sale. The panel also determined that the production materials did not display consistent, widely identifiable visual characteristics of the depicted characters ' the prerequisite for character protection. Because of this, the production materials did not inject the entire character into the public domain, only the particular images contained therein.

After determining that the promotional materials were in the public domain, the panel went on to determine whether AVELA's use of the extracted images infringed on Warner Bros.' copyrights in the associated films. The panel held that AVELA had a general right to modify or make new works based on public domain materials. However, AVELA infringed the film copyrights by combining extracted images together, or with phrases from the movie or underlying novel, or by converting the extracted images into three-dimensional figurines. Each of these classes of product evokes the film character in ways that the individual items of public domain material did not. By contrast, AVELA's products that included only a single, faithfully reproduced, extracted image did not infringe Warner Bros.' copyrights when they were printed on new surfaces, such as T-shirts or lunchboxes. As a consequence of these rulings, the Eighth Circuit affirmed the district court's finding of infringement, vacated the permanent injunction as it applied to products containing a single, faithfully reproduced extracted image, but affirmed the decision as it applied to combined extracted images, extracted images combined with phrases, and three-dimensional figurines based on extracted images.

Jeffrey S. Ginsberg is a partner and Wyatt Delfino is a summer associate in the New York office of Kenyon & Kenyon LLP.

Dosage Suggestion Need Not Teach Efficacy to Render Dosage Claim Obvious

On June 22, 2011, the Federal Circuit delivered its opinion in Tyco Healthcare LP v. Mutual Pharm. Co., Inc., No. 2010-1513, which involved claims 1 and 2 of U.S. Patent No. 5,211,954, (“the '954 patent”). These claims cover formulations of the sleep-inducing drug temazepam, and were identical, except that claim 1 claims capsules containing 6 to 8 mg of temazepam, while claim 2 claims 7.5 mg capsules. The '954 patent issued on May 18, 1993 with a priority date of Sept. 23, 1986.

In November 2006, Mutual Pharmaceutical Company, Inc. (“Mutual”) filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to manufacture and sell a generic version of the 7.5 mg temazepam capsules. Tyco responded by filing an infringement lawsuit, and when Mutual received tentative FDA approval for its ANDA, Tyco moved for a preliminary injunction to block Mutual from selling generic temazepam.

At trial, the district court denied Tyco's preliminary injunction motion, and granted Mutual's motion for summary judgment of invalidity, concluding that the '954 claims were obvious. In reaching that conclusion, the court relied primarily on three facts. First, capsules containing 15 and 30 mg dosages of temazepam, but otherwise identical to those claimed in the '954 patent, had been sold in the United States more than one year before the patent's priority date. Second, a 1983 volume of the British National Formulary (“BNF”) disclosed using dosages of temazepam of 5 to 15 mg for the treatment of insomnia in the elderly. Third, neither party disputed the maxim that “physicians always seek to prescribe the lowest effective does of any medication, particularly hypnotics such as temazepam.” These three undisputed facts led the district court to conclude that it would have been obvious to anyone of ordinary skill in the art to combine the pre-existing 15 mg temazepam capsule with the dosage range identified in the BNF reference. Tyco appealed.

A panel of the Federal Circuit affirmed the district court's ruling and held that the BNF reference, combined with the pre-existing temazepam capsules, would have been sufficient to render a 7.5 mg capsule obvious. The court was unpersuaded by Tyco's argument that the BNF prior art did not provide any evidence or discussion of the efficacy of lower dosages of temazepam, because the claims of the '954 patent had no efficacy limitations. The Federal Circuit also found Tyco's arguments of teaching away, unexpected results, and commercial success unavailing.

Eighth Circuit Limits Use of Uncopyrighted Promotional Material for Copyrighted Films

On July 5, 2011, a panel of the Eighth Circuit Court of Appeals, consisting of Judges Raymond W. Gruender, Duane Benton, and Bobby E. Shepherd, issued a unanimous opinion, authored by Judge Gruender, in Warner Bros. Entertainment Inc. et al. v. X One X Productions et al., No. 10-1743. In Warner Bros., the Eighth Circuit was called upon to review the lower court's finding that a group of defendants infringed Warner Bros.' copyright in several films when they sold images extracted from publicity materials for those films. The panel held that, while the particular publicity images were in the public domain, the defendants could not combine extracted images together, or with text, or use them to create figurines, without infringing on Warner Bros.' copyrights in the respective films.

Warner Bros. owns the copyright to the 1939 films “The Wizard of Oz,” and “Gone with the Wind,” as well as several short Tom & Jerry cartoon films that debuted between 1940 and 1957. Before the films were completed and copyrighted, publicity materials featuring images of the actors in costume were distributed to theaters and published in newspapers and magazines. The images in the publicity materials consisted of photographs taken before or during production of the films, or, in the case of the cartoons, independently drawn images, and were not taken from footage used in the films. The publicity materials did not comply with the copyright notice requirements of the 1909 Copyright Act, 17 U.S.C. ” 1 et seq., which was in effect during the relevant period, and Warner Bros. conceded that it had no registered copyright in the publicity materials themselves.

Defendants A.V.E.L.A.., Inc., X One X Productions, and Art-Nostalgia.com, Inc. (collectively, “AVELA”) acquired restored versions of the promotional material and extracted images of famous characters, including Dorothy, Tin Man, Scarlett O'Hara, Tom and Jerry, and licensed the images for use on items such as shirts, and lunchboxes, and as models for three-dimensional figurines. AVELA often modified the images by adding the character's signature phrase from the movie, or combining extracted images from different publicity materials into a single product.

Warner Bros. sued AVELA for copyright infringement. The district court determined that, regardless of whether the publicity materials were in the public domain, AVELA's practice of modifying the extracted images infringed the film's copyright. Warner Bros. averred that it would not assert the copyrights against unaltered reproductions of the individual items of publicity material, which eliminated any need for the district court to resolve whether the publicity materials were in the public domain. Based on its findings, the district court entered a permanent injunction barring all use of the publicity material beyond exact duplication of the individual items, which AVELA appealed.

On appeal, the Eighth Circuit panel determined that it was necessary to decide if, and to what extent, the publicity images were in the public domain. The panel determined that the images were in the public domain because they had been distributed to theaters without the statutorily required notice, and were not subject to the limited publication exception. In doing so, the Eighth Circuit adopted the framework for limited publication developed by the Ninth Circuit, as articulated in White v. Kimmel , 193 F.2d 744, 746-47 (9th Cir. 1952), which requires limited distribution be to a definitely selected class of persons without the right of reproduction, distribution, or sale. The panel also determined that the production materials did not display consistent, widely identifiable visual characteristics of the depicted characters ' the prerequisite for character protection. Because of this, the production materials did not inject the entire character into the public domain, only the particular images contained therein.

After determining that the promotional materials were in the public domain, the panel went on to determine whether AVELA's use of the extracted images infringed on Warner Bros.' copyrights in the associated films. The panel held that AVELA had a general right to modify or make new works based on public domain materials. However, AVELA infringed the film copyrights by combining extracted images together, or with phrases from the movie or underlying novel, or by converting the extracted images into three-dimensional figurines. Each of these classes of product evokes the film character in ways that the individual items of public domain material did not. By contrast, AVELA's products that included only a single, faithfully reproduced, extracted image did not infringe Warner Bros.' copyrights when they were printed on new surfaces, such as T-shirts or lunchboxes. As a consequence of these rulings, the Eighth Circuit affirmed the district court's finding of infringement, vacated the permanent injunction as it applied to products containing a single, faithfully reproduced extracted image, but affirmed the decision as it applied to combined extracted images, extracted images combined with phrases, and three-dimensional figurines based on extracted images.

Jeffrey S. Ginsberg is a partner and Wyatt Delfino is a summer associate in the New York office of Kenyon & Kenyon LLP.