1. International Conference on Harmonization. ICH harmonized tripartite guideline: Q5E comparability of biotechnological/biological
products subject to shanges in their manufacturing process. 70 Fed. Reg. 37861–62. 2005 Jun 30. See also FDA Guidance concerning
demonstration of comparability of human biological products, including therapeutic biotechnology-derived products. 61 Fed.
Reg. 18612–13. 1996 Apr 26.
2. Berlex Laborat ories, Inc. v. FDA, 942 F. Supp. 19, 25 (D.D.C. 1996).
3. US Food and Drug Administration. Dockets. Available from: http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4389s1-01-FDA.pdf; http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4389b1-04-Genzyme.pdf. See also http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm.
4. Federal Trade Commission Report. Emerging Health Care Issues: Follow-on biologic drug competition 2009. Jun; 52–63. Available
from: http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf (PDF pages 68-79). See also http://www.ftc.gov/os/comments/healthcarecompissues/537778-00009.pdf and http://www.ftc.gov/os/comments/healthcarecompissues/537778-00032.pdf.
5. Biogen, Inc. v. Schering AG, 954 F. Supp. 391 (D. Mass. 1996). See also Biogen, Inc. v. Berlex Laboratories, Inc., 318
F.3d 1132 (Fed. Cir. 2003).
6. Schering Corp. & Biogen, Inc. v. Amgen Inc., 969 F. Supp. 258 (D. Del. 1997). See also Schering Corp. & Biogen, Inc. v.
Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000).
7. Genentech, Inc. v. Boehringer Mannheim, 47 F. Supp. 2d 91 (D. Mass. 1999).
8. Kleid DG. Patent Litigations. In: Scientist and patent agent at Genentech: An oral history conducted in 2001 and 2002
by Sally Smith Hughes for the Regional Oral History Office. The Bancroft Library. University of California, Berkeley; 2002.
Available from: http://content.cdlib.org/view?docId=hb1t1n98fg;NAAN=13030&doc.view=frames&chunk.id=div00167&toc.depth=1&toc.id=div00047&brand=calisphere.