Nacto - indian company's Copaxone process patent http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PG01&s1=%22natco+pharma%22&OS=%22natco+pharma%22&RS=%22natco+pharma%22 However, I don't see any patent application from this company or Mylan on characterization or how they assess the quality of product. It'll be interesting to see how they are satisfying the "sameness" criteria.