TO: Professor Risch
FROM: Meghan Hanlon
DATE: November 10, 2007
RE: Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254 (2007)
Facts:
Daiichi Pharmaceuticals is the owner of U.S. Pat. No. 5,401,741 (“the ‘741 patentâ€). Claim 1 of the ‘741 patent states “a method for treating otopathy which comprises the topical otic administration of an amount of ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy.†Apotex filed an Abbreviated New Drug Application (“ANDAâ€) seeking approval to manufacture a generic ofloxacin ear drop. Apotex included a certification that the ‘741 patent was invalid and/or not infringed. When Daiichi received the ANDA and the certification, it sued Apotex for infringement.
Procedural History:
Daiichi sued Apotex for infringement of its ‘741 patent for an ofloxacin based ear drop. The district court held that the ‘741 patent was valid. And because Apotex stipulated that the subject matter of its ANDA fell within the claim language of the ‘741 patent, the court found that Apotex infringed the ‘741 patent. Apotex appealed. The Court of Appeals held that the ‘741 was invalid due to obviousness and reversed the district court’s ruling.
Issue:
Would the creation of an ofloxacin based ear drop have been obvious to a person engaged in developing new pharmaceuticals, formulations and treatment methods, or specialist in ear treatments such as an otologist, otolaryngologist, or otohinolaryngologist?
Holding:
A 1986 article by Horst Ganz condoned the use of ciprofloxacin, a gyrase inhibitor that would be suitable for use as ear drops. Ofloxacin is in the same antibiotic family as ciprofloxacin. The district court erred in finding that a person of ordinary skill in the art would not know that ofloxacin would be as equally effective as ciprofloxacin to treat ear maladies. Because this substitution would have been obvious to someone with ordinary skill in the art, the ‘741 patent is invalid, and Apotex did not infringe.
Reasoning:
To determine obviousness one must analyze: “1) the scope and content of the prior art; 2) the level of ordinary skill in the prior art; 3) the differences between the claimed invention and the prior art; and 4) objective evidence of nonobviousness.†In re Dembiczak, 175 F.3d 994, 998 (Fed.Cir.1999).The factors that may be considered in the determination of the level of ordinary skill in a particular art include: 1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.†Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381-82 (Fed.Cir.1983)).
The district court erred in finding that a person of ordinary skill in the art would be that of a general practitioner. A general practitioner would not have the knowledge or training to develop the compound used in the ‘741 compound. The correct level of skill in the art would be found in someone engaged in developing new pharmaceuticals, formulations and treatment methods, or specialist in ear treatments such as an otologist, otolaryngologist, or otohinolaryngologist To a person of this skill the ‘741 patent would be an obvious invention.
FROM: Meghan Hanlon
DATE: November 10, 2007
RE: Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254 (2007)
Facts:
Daiichi Pharmaceuticals is the owner of U.S. Pat. No. 5,401,741 (“the ‘741 patentâ€). Claim 1 of the ‘741 patent states “a method for treating otopathy which comprises the topical otic administration of an amount of ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy.†Apotex filed an Abbreviated New Drug Application (“ANDAâ€) seeking approval to manufacture a generic ofloxacin ear drop. Apotex included a certification that the ‘741 patent was invalid and/or not infringed. When Daiichi received the ANDA and the certification, it sued Apotex for infringement.
Procedural History:
Daiichi sued Apotex for infringement of its ‘741 patent for an ofloxacin based ear drop. The district court held that the ‘741 patent was valid. And because Apotex stipulated that the subject matter of its ANDA fell within the claim language of the ‘741 patent, the court found that Apotex infringed the ‘741 patent. Apotex appealed. The Court of Appeals held that the ‘741 was invalid due to obviousness and reversed the district court’s ruling.
Issue:
Would the creation of an ofloxacin based ear drop have been obvious to a person engaged in developing new pharmaceuticals, formulations and treatment methods, or specialist in ear treatments such as an otologist, otolaryngologist, or otohinolaryngologist?
Holding:
A 1986 article by Horst Ganz condoned the use of ciprofloxacin, a gyrase inhibitor that would be suitable for use as ear drops. Ofloxacin is in the same antibiotic family as ciprofloxacin. The district court erred in finding that a person of ordinary skill in the art would not know that ofloxacin would be as equally effective as ciprofloxacin to treat ear maladies. Because this substitution would have been obvious to someone with ordinary skill in the art, the ‘741 patent is invalid, and Apotex did not infringe.
Reasoning:
To determine obviousness one must analyze: “1) the scope and content of the prior art; 2) the level of ordinary skill in the prior art; 3) the differences between the claimed invention and the prior art; and 4) objective evidence of nonobviousness.†In re Dembiczak, 175 F.3d 994, 998 (Fed.Cir.1999).The factors that may be considered in the determination of the level of ordinary skill in a particular art include: 1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.†Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381-82 (Fed.Cir.1983)).
The district court erred in finding that a person of ordinary skill in the art would be that of a general practitioner. A general practitioner would not have the knowledge or training to develop the compound used in the ‘741 compound. The correct level of skill in the art would be found in someone engaged in developing new pharmaceuticals, formulations and treatment methods, or specialist in ear treatments such as an otologist, otolaryngologist, or otohinolaryngologist To a person of this skill the ‘741 patent would be an obvious invention.