Obviousness of Life Sciences Innovations

Obviousness - 35 U.S.C. § 103

Even if the subject matter sought to be patented is not exactly shown by the prior art, and involves one or more differences over the most nearly similar thing already known, a patent may still be refused if the differences would be obvious. The subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention. For example, the substitution of one color for another, or changes in size, are ordinarily not patentable.

1. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)Acrobat
2. KSR v. Teleflex - U.S. Supreme Court Oral Argument Transcript (November 28, 2006)Acrobat

Post-KSR Obviousness (Biologics and Pharmaceuticals cases):

1. Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. June 28, 2007)Acrobat
2. Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. July 9, 2007)Acrobat
3. Forest Laboratories v. Ivax Pharmaceuticals (Fed. Cir. September 5, 2007)Acrobat
4. Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. September 11, 2007)Acrobat
5. Daiichi Sankyo Co., LTD (formerly known as Daiichi Pharmaceutical Co., Ltd) v. Apotex (Fed. Cir. September 12, 2007)Acrobat
6. Innogenetics v. Abbott Laboratories (Fed. Cir. January 17, 2008)Acrobat
7. Ortho-McNeil Pharmaceutical Inc. v. Mylan Laboratories Inc. (Fed. Cir. March 31, 2008)Acrobat
8. Eisai Co. Ltd. v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. July 21, 2008)Acrobat
9. In re Omeprazole Patent Litigation (Fed. Cir. August 20, 2008)Acrobat
10. In Re Swanson (Fed. Cir. September 4, 2008)Acrobat
11. Sanofi Synthelabo v. Apotex Inc. (Fed. Cir. December 12, 2008)Acrobat

Case Study: In re Kubin Are polynucleotide (gene) sequences obvious once the polypeptide (protein) sequences are known? In re Kubin (Fed. Cir. April 3, 2009)Acrobat Compare: In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) Patent Application on Appeal: U.S. Application Pub. No. 20080081043 (cl. 48)

1. The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. May 13, 2009)Acrobat
2. Altana Pharma AG v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. May 14, 2009)Acrobat
3. Bayer Schering Pharma AG v. Barr Laboratories Inc. (Fed. Cir. August 5, 2009)Acrobat

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