IP News

Professor Moore Confirmed as Federal Circuit Judge

On Sept. 5, 2006, the U.S. Senate confirmed the appointment of law professor and IP author Kimberly Ann Moore to the U.S. Court of Appeals for the Federal Circuit. Moore replaces Judge Raymond C. Clevenger, III, who is retiring. The court will now have 12 regular judges.

Moore is President Bush's second appointment to the Federal Circuit. In 2001, he appointed Judge Sharon Prost, the former chief counsel for the U.S. Senate Committee on the Judiciary. 

Rocket Docket Bill Passes House Judiciary Committee

The House Judiciary Committee unanimously approved a bill, first introduced by Rep. Darrell Issa (R-CA) in May 2006, which would establish a pilot project in at least five district courts where judges would have the choice of opting in to the new program to hear patent cases. Under the present form of the bill, a participant district must have at least 10 authorized judges with at least three opting in to the program. Each of the test courts will be assigned a clerk with expertise in patent law or with the technical issues arising in patent cases. The bill will also allocate funding to provide educational opportunities for judges who opt in to the program.

The pilot program will last no longer than 10 years, and periodic studies will occur to determine the pilot project's success. A comparison will be conducted of reversal rates, pendency, and evidence of forum shopping among courts both within the program and without. The bill also calls for the Federal Judicial Center to be consulted.

U.S. Sentencing Commission Promulgates Emergency Guideline Amendment on IP Crimes

In response to the 'Stop Counterfeiting in Manufactured Goods Act' (the 'Act'), the U.S. Sentencing Commission voted unanimously to promulgate an emergency amendment to the sentencing guideline for criminal copyright or trademark infringement. The Act, signed into law by President Bush on March 16, 2006, directed the Commission to review and, if appropriate, amend the sentencing guidelines applicable to persons convicted of an offense under either 18 U.S.C. '2318 (trafficking in counterfeit labels) or 18 U.S.C. '2320 (trafficking in counterfeit goods or services).

The guideline amendment addresses the way in which courts determine the 'infringement amount' for the offense, which is a factor used in
calculating the magnitude of a sentencing enhancement to be applied in these cases. The amendment clarifies that in cases in which counterfeit labels are not affixed to goods, the 'infringement amount' is based on the retail value of the genuine goods that the counterfeit label would help imitate if the counterfeit goods appear to be identifiable, genuine goods.

For example, in a case in which an offender trafficked counterfeit tags to be used on designer purses, in determining the guideline sentencing enhancement, the infringement amount would be based on the value of the genuine designer purses, if they can be identified and would appear to a reasonably informed purchaser to
be genuine.

The emergency guideline amendment took effect Sept. 12, 2006. For the emergency amendment to be made permanent, the amendment must be re-promulgated on or before May 1, 2007. The U.S. Sentencing Commission, an independent agency in the judicial branch of the federal government, was organized in 1985 to develop a national sentencing
policy for the federal courts.

Federal Circuit Rules That Expert Testimony Can Provide Evidence of Motivation to Combine Prior Art in Obviousness Case

In Alza Corp. v. Mylan Labs., Inc., No. 06-1019, 2006 WL 2556356 (Fed. Cir. Sept. 6, 2006), the Federal Circuit upheld a district court decision that U.S. Patent No. 6,124,355 (the '355 patent), which claims an extended-release formulation of the incontinence drug oxybutynin, was invalid for obviousness. Oxybutynin is the active ingredient in Mylan's Ditropan XL'.

Claim 2 of the '355 patent states:

A sustained-release oxybutynin formulation for oral administration to a patient in need of treatment for urge incontinence comprising a therapeutic dose of an
oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.25 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating urge incontinence in the patient. (emphasis added)

The district court construed the claim 'delivers' to refer to the rate of in vivo release in the gastrointestinal tract.

The Federal Circuit first reviewed the 'motivation-suggestion-teaching' test. Citing its opinions in Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293 (Fed. Cir. 2005) and In re Kahn, 441 F.3d 977 (Fed. Cir. 2006), the court said, 'There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art.'

The issue in this case was whether one skilled in the art at the invention date would have believed oxybutynin would be absorbed in the colon, and whether such a belief would have provided a motivation to adapt extended-release technology to obtain Alza's invention. After a drug is ingested, it is dissolved in the gastrointestinal tract and reabsorbed into the bloodstream. Typically, after 8-12 hours, the drug will reach the colon. Not all drugs are reabsorbed by the colon, however. Therefore, hypothetically, unless it is believed that a particular drug is reabsorbed into the colon, then there would be little motivation to develop a dosage form capable of releasing drug in the colon. Alza argued that one of ordinary skill would not have believed that oxybutynin could be absorbed in the colon. The Federal Circuit supported the lower court's reliance on expert testimony that 'the general understanding at the time' was that oxybutynin would be absorbed in the colon.

The Federal Circuit also affirmed the district court's ruling that Mylan's ANDA formulation did not infringe the '355 patent. At trial, Alza presented evidence of: 1) the rate at which Mylan's product released oxybutynin in an in vitro dissolution apparatus, and 2) the rate at which Mylan's product resulted in the accumulation of oxybutynin in the bloodstream. The Federal Circuit agreed with the district court that the evidence presented failed to establish the in vivo release rates of Mylan's and Alza's formulations.

Professor Moore Confirmed as Federal Circuit Judge

On Sept. 5, 2006, the U.S. Senate confirmed the appointment of law professor and IP author Kimberly Ann Moore to the U.S. Court of Appeals for the Federal Circuit. Moore replaces Judge Raymond C. Clevenger, III, who is retiring. The court will now have 12 regular judges.

Moore is President Bush's second appointment to the Federal Circuit. In 2001, he appointed Judge Sharon Prost, the former chief counsel for the U.S. Senate Committee on the Judiciary. 

Rocket Docket Bill Passes House Judiciary Committee

The House Judiciary Committee unanimously approved a bill, first introduced by Rep. Darrell Issa (R-CA) in May 2006, which would establish a pilot project in at least five district courts where judges would have the choice of opting in to the new program to hear patent cases. Under the present form of the bill, a participant district must have at least 10 authorized judges with at least three opting in to the program. Each of the test courts will be assigned a clerk with expertise in patent law or with the technical issues arising in patent cases. The bill will also allocate funding to provide educational opportunities for judges who opt in to the program.

The pilot program will last no longer than 10 years, and periodic studies will occur to determine the pilot project's success. A comparison will be conducted of reversal rates, pendency, and evidence of forum shopping among courts both within the program and without. The bill also calls for the Federal Judicial Center to be consulted.

U.S. Sentencing Commission Promulgates Emergency Guideline Amendment on IP Crimes

In response to the 'Stop Counterfeiting in Manufactured Goods Act' (the 'Act'), the U.S. Sentencing Commission voted unanimously to promulgate an emergency amendment to the sentencing guideline for criminal copyright or trademark infringement. The Act, signed into law by President Bush on March 16, 2006, directed the Commission to review and, if appropriate, amend the sentencing guidelines applicable to persons convicted of an offense under either 18 U.S.C. '2318 (trafficking in counterfeit labels) or 18 U.S.C. '2320 (trafficking in counterfeit goods or services).

The guideline amendment addresses the way in which courts determine the 'infringement amount' for the offense, which is a factor used in
calculating the magnitude of a sentencing enhancement to be applied in these cases. The amendment clarifies that in cases in which counterfeit labels are not affixed to goods, the 'infringement amount' is based on the retail value of the genuine goods that the counterfeit label would help imitate if the counterfeit goods appear to be identifiable, genuine goods.

For example, in a case in which an offender trafficked counterfeit tags to be used on designer purses, in determining the guideline sentencing enhancement, the infringement amount would be based on the value of the genuine designer purses, if they can be identified and would appear to a reasonably informed purchaser to
be genuine.

The emergency guideline amendment took effect Sept. 12, 2006. For the emergency amendment to be made permanent, the amendment must be re-promulgated on or before May 1, 2007. The U.S. Sentencing Commission, an independent agency in the judicial branch of the federal government, was organized in 1985 to develop a national sentencing
policy for the federal courts.

Federal Circuit Rules That Expert Testimony Can Provide Evidence of Motivation to Combine Prior Art in Obviousness Case

In Alza Corp. v. Mylan Labs., Inc., No. 06-1019, 2006 WL 2556356 (Fed. Cir. Sept. 6, 2006), the Federal Circuit upheld a district court decision that U.S. Patent No. 6,124,355 (the '355 patent), which claims an extended-release formulation of the incontinence drug oxybutynin, was invalid for obviousness. Oxybutynin is the active ingredient in Mylan's Ditropan XL'.

Claim 2 of the '355 patent states:

A sustained-release oxybutynin formulation for oral administration to a patient in need of treatment for urge incontinence comprising a therapeutic dose of an
oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.25 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating urge incontinence in the patient. (emphasis added)

The district court construed the claim 'delivers' to refer to the rate of in vivo release in the gastrointestinal tract.

The Federal Circuit first reviewed the 'motivation-suggestion-teaching' test. Citing its opinions in Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc. , 424 F.3d 1293 (Fed. Cir. 2005) and In re Kahn, 441 F.3d 977 (Fed. Cir. 2006), the court said, 'There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art.'

The issue in this case was whether one skilled in the art at the invention date would have believed oxybutynin would be absorbed in the colon, and whether such a belief would have provided a motivation to adapt extended-release technology to obtain Alza's invention. After a drug is ingested, it is dissolved in the gastrointestinal tract and reabsorbed into the bloodstream. Typically, after 8-12 hours, the drug will reach the colon. Not all drugs are reabsorbed by the colon, however. Therefore, hypothetically, unless it is believed that a particular drug is reabsorbed into the colon, then there would be little motivation to develop a dosage form capable of releasing drug in the colon. Alza argued that one of ordinary skill would not have believed that oxybutynin could be absorbed in the colon. The Federal Circuit supported the lower court's reliance on expert testimony that 'the general understanding at the time' was that oxybutynin would be absorbed in the colon.

The Federal Circuit also affirmed the district court's ruling that Mylan's ANDA formulation did not infringe the '355 patent. At trial, Alza presented evidence of: 1) the rate at which Mylan's product released oxybutynin in an in vitro dissolution apparatus, and 2) the rate at which Mylan's product resulted in the accumulation of oxybutynin in the bloodstream. The Federal Circuit agreed with the district court that the evidence presented failed to establish the in vivo release rates of Mylan's and Alza's formulations.