35 U.S.C. § 101

• "Whoever invents or discovers any new and useful process, machine, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore..."

35 U.S.C. § 102

• Was the claimed invention already patented, described in a printed publication, or in public use, on sale or otherwise available to the public as of the filing date ("prior art"),

35 U.S.C. § 103

• A patent may not be obtained if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious to a person of ordinary skill in the art. 
  

35 U.S.C. § 112

• Res ipsum n of ordinary skill in the art. 
  

Pharmaceutical and Biotech Patent Law 

Biotechnology and pharmaceutical patents: law and practice

Thomas and Holman on Pharmaceutical Patent Law 
2nd ed

Milgrim on Trade Secrets

U.S. Biotechnology Patent Law 

Building Biotechnology

ANDA Litigation, 3rd Edition

Pre-ANDA Litigation, 3rd Edition

Biosimilars Litigation and Client Counseling