IP News

Federal Circuit Denies En Banc Rehearing in Fosamax Case

The U.S. Court of Appeals for the Federal Circuit denied Merck & Co.'s petition for an en banc rehearing of the decision in Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005). In Merck, the Federal Circuit reversed a ruling of the U.S. District Court for the District of Delaware and invalidated one of the patents covering Fosamax, a blockbuster osteoporosis treatment. The Federal Circuit also found that evidence of Fosamax's commercial success was not probative of obviousness because others were legally barred from testing the invention disclosed in the patent-in-suit as a result of other patents held by Merck.

Federal Circuit Remands Case Involving Razor Patent

In Gillette Co. v. Energizer Holdings, Inc., No. 04-1220, 2005 WL 992023 (Fed. Cir. Apr. 29, 2005), the U.S. Court of Appeals for the Federal Circuit vacated and remanded a decision by the U.S. District Court for the District of Massachusetts denying Gillette's motion for a preliminary injunction. The case involves a dispute over whether Energizer's Quattro' razor infringes U.S. Patent No. 6,212,777 (“the '777 patent”). Claim 1 of the '777 patent, which issued on Aug. 10, 2001, is directed to a razor “comprising … a group of first, second, and third blades. … ”

Prior to Energizer's launch of the Quattro' razor, Gillette sued Energizer and moved for a preliminary injunction. The Quattro' razor is a wet-shave safety razor with four blades. The district court denied Gillette's motion, finding that the scope of the '777 patent is limited to a razor with three blades.

On appeal, the Federal Circuit disagreed with the district court's claim construction. Specifically, the court found that the use of the terms “comprising” and “group of” indicates that the claims of the '777 patent cover razors with more than three blades. The court also noted that the object of the invention is to reduce “drag forces” in safety razors, and that the prior art problem solved by the invention is not attributable to the three blades themselves, but rather to their spatial arrangement. Finally, the court found that the terms “first, second, and third” are terms used to distinguish different elements of the claim, not terms used to supply a numerical limit.

Judge Glenn L. Archer, Jr. dissented from the majority's opinion, arguing that the claim and the specification of the '777 patent clearly indicate that the invention is limited to a razor with three blades.

Federal Circuit Decides False Marking Case

The Federal Circuit decided a rare case on falsely marked products in Clontech Labs., Inc. v. Invitrogen Corp., Nos. 03-1464, 04-1099, 2005 WL 1038775 (Fed. Cir. May 5, 2005). Clontech required the court to interpret 35 U.S.C. '292, which provides in pertinent part that: “[w]hoever marks upon, or affixes to, or uses in advertising in connection with any article, the words “patent” or any word or number importing that the same is patented, for the purposes of deceiving the public … [s]hall be fined not more than $500 for every such offense.” The court affirmed-in-part, reversed-in-part, vacated-in-part, and remanded the case to the district court for further proceedings.

The four patents at issue are owned by Invitrogen and are directed to reverse transcriptase polypeptides (“RTs”) and methods for using such RTs to prepare DNA molecules. All of the patents contain the claim limitation “substantially no RNase H activity,” or similar language. The products at issue are RTs known as SUPERSCRIPT (“SS”) and SUPERSCRIPT II (“SSII”), which had been marked with all four patents. Invitrogen also sells kits containing SSII and a variety of cDNA libraries purportedly made using SSII. These kits and libraries had been marked with some of the patents at issue.

The district court found that Invitrogen's SS, SSII, kits, and library products had been falsely marked with intent to deceive the public. The court relied on evidence that Invitrogen had performed experiments in 2000 using an assay that was defined in the patent specifications as having the express purpose of determining whether the product meets the “substantially no RNase H activity” limitation. Some of the tests appeared to indicate that SS and SSII exhibited more than “substantially no RNase H activity.” As a result, the court held that these experiments put Invitrogen on notice that the products were not covered by the patents in suit. According to the court, since Invitrogen failed to correct its mistake, such conduct rose to the level of deceptive intent.

On appeal, Invitrogen argued that the district court had misunderstood the legal standard for proving deceptive intent and misinterpreted the results of the 2000 experiments. The Federal Circuit held that to establish deceptive intent, a plaintiff must show by a preponderance of the evidence that the party accused of false marking did not have a reasonable belief that the articles were properly marked. After reviewing the trial testimony, the court noted that defendant's expert had given unchallenged testimony that the 2000 experiments demonstrated that the tested RTs had “no detectable RNase activity.” As such, the Federal Circuit found that the district court clearly erred by finding that Invitrogen had acted with deceptive intent. The court affirmed, however, the district court's holding that Invitrogen's cDNA libraries were falsely marked because it found that Invitrogen had waived its arguments by raising them for the first time on appeal.

Senators Introduce BioShield II Legislation

Senators Joseph Lieberman and Orrin Hatch introduced new legislation, known as BioShield II, designed to provide additional incentives for pharmaceutical companies to develop biodefense countermeasures. (BioShield I, signed into law by President Bush in July 2004, authorized $5.6 billion to aid the development of antiterrorism drugs.) The new incentives include tax breaks, intellectual property protections, and liability protections. The intellectual property protections include a provision that would restore patent terms held by the National Institutes of Health (“NIH”) to encourage companies to license NIH-funded technologies and further develop them. Such companies would receive a 17-year patent if they turn an NIH technology into an FDA-approved product before the NIH patent expires. The legislation also contains a “wild card” provision, which grants a company that develops a countermeasure a 2-year patent extension on any drug the company markets.

Federal Circuit Denies En Banc Rehearing in Fosamax Case

The U.S. Court of Appeals for the Federal Circuit denied Merck & Co.'s petition for an en banc rehearing of the decision in Merck & Co. v. Teva Pharms. USA, Inc. , 395 F.3d 1364 (Fed. Cir. 2005). In Merck, the Federal Circuit reversed a ruling of the U.S. District Court for the District of Delaware and invalidated one of the patents covering Fosamax, a blockbuster osteoporosis treatment. The Federal Circuit also found that evidence of Fosamax's commercial success was not probative of obviousness because others were legally barred from testing the invention disclosed in the patent-in-suit as a result of other patents held by Merck.

Federal Circuit Remands Case Involving Razor Patent

In Gillette Co. v. Energizer Holdings, Inc., No. 04-1220, 2005 WL 992023 (Fed. Cir. Apr. 29, 2005), the U.S. Court of Appeals for the Federal Circuit vacated and remanded a decision by the U.S. District Court for the District of Massachusetts denying Gillette's motion for a preliminary injunction. The case involves a dispute over whether Energizer's Quattro' razor infringes U.S. Patent No. 6,212,777 (“the '777 patent”). Claim 1 of the '777 patent, which issued on Aug. 10, 2001, is directed to a razor “comprising … a group of first, second, and third blades. … ”

Prior to Energizer's launch of the Quattro' razor, Gillette sued Energizer and moved for a preliminary injunction. The Quattro' razor is a wet-shave safety razor with four blades. The district court denied Gillette's motion, finding that the scope of the '777 patent is limited to a razor with three blades.

On appeal, the Federal Circuit disagreed with the district court's claim construction. Specifically, the court found that the use of the terms “comprising” and “group of” indicates that the claims of the '777 patent cover razors with more than three blades. The court also noted that the object of the invention is to reduce “drag forces” in safety razors, and that the prior art problem solved by the invention is not attributable to the three blades themselves, but rather to their spatial arrangement. Finally, the court found that the terms “first, second, and third” are terms used to distinguish different elements of the claim, not terms used to supply a numerical limit.

Judge Glenn L. Archer, Jr. dissented from the majority's opinion, arguing that the claim and the specification of the '777 patent clearly indicate that the invention is limited to a razor with three blades.

Federal Circuit Decides False Marking Case

The Federal Circuit decided a rare case on falsely marked products in Clontech Labs., Inc. v. Invitrogen Corp., Nos. 03-1464, 04-1099, 2005 WL 1038775 (Fed. Cir. May 5, 2005). Clontech required the court to interpret 35 U.S.C. '292, which provides in pertinent part that: “[w]hoever marks upon, or affixes to, or uses in advertising in connection with any article, the words “patent” or any word or number importing that the same is patented, for the purposes of deceiving the public … [s]hall be fined not more than $500 for every such offense.” The court affirmed-in-part, reversed-in-part, vacated-in-part, and remanded the case to the district court for further proceedings.

The four patents at issue are owned by Invitrogen and are directed to reverse transcriptase polypeptides (“RTs”) and methods for using such RTs to prepare DNA molecules. All of the patents contain the claim limitation “substantially no RNase H activity,” or similar language. The products at issue are RTs known as SUPERSCRIPT (“SS”) and SUPERSCRIPT II (“SSII”), which had been marked with all four patents. Invitrogen also sells kits containing SSII and a variety of cDNA libraries purportedly made using SSII. These kits and libraries had been marked with some of the patents at issue.

The district court found that Invitrogen's SS, SSII, kits, and library products had been falsely marked with intent to deceive the public. The court relied on evidence that Invitrogen had performed experiments in 2000 using an assay that was defined in the patent specifications as having the express purpose of determining whether the product meets the “substantially no RNase H activity” limitation. Some of the tests appeared to indicate that SS and SSII exhibited more than “substantially no RNase H activity.” As a result, the court held that these experiments put Invitrogen on notice that the products were not covered by the patents in suit. According to the court, since Invitrogen failed to correct its mistake, such conduct rose to the level of deceptive intent.

On appeal, Invitrogen argued that the district court had misunderstood the legal standard for proving deceptive intent and misinterpreted the results of the 2000 experiments. The Federal Circuit held that to establish deceptive intent, a plaintiff must show by a preponderance of the evidence that the party accused of false marking did not have a reasonable belief that the articles were properly marked. After reviewing the trial testimony, the court noted that defendant's expert had given unchallenged testimony that the 2000 experiments demonstrated that the tested RTs had “no detectable RNase activity.” As such, the Federal Circuit found that the district court clearly erred by finding that Invitrogen had acted with deceptive intent. The court affirmed, however, the district court's holding that Invitrogen's cDNA libraries were falsely marked because it found that Invitrogen had waived its arguments by raising them for the first time on appeal.

Senators Introduce BioShield II Legislation

Senators Joseph Lieberman and Orrin Hatch introduced new legislation, known as BioShield II, designed to provide additional incentives for pharmaceutical companies to develop biodefense countermeasures. (BioShield I, signed into law by President Bush in July 2004, authorized $5.6 billion to aid the development of antiterrorism drugs.) The new incentives include tax breaks, intellectual property protections, and liability protections. The intellectual property protections include a provision that would restore patent terms held by the National Institutes of Health (“NIH”) to encourage companies to license NIH-funded technologies and further develop them. Such companies would receive a 17-year patent if they turn an NIH technology into an FDA-approved product before the NIH patent expires. The legislation also contains a “wild card” provision, which grants a company that develops a countermeasure a 2-year patent extension on any drug the company markets.