References
- National Drug Code Directory. [Internet]. Maryland: US Food and Drug Administration, Application number: 103463. 1986. [cited 2017 Jan 27]. Available from: http://wcww.accessdata.fda.gov/scripts/cder/ndc/default.cfm. (Database).
- Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion. Tufts Center for the Study of Drug Development, 2014 Nov 18. [cited 2016 May 1]. Available from: http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study.
- Storz U, Flasche W, Driehaus J. IP issues of therapeutic antibodies. Intellectual property issues. Springer Briefs in Biotech Patents. 2012. doi: 10.1007/978-3-642-29526-3_1. *
- Holliday L. Patenting antibodies in Europe. MAbs. 2009;1(40):385–386.
- Metcalf DG. Legal Update/Therapeutic antibody patent infringement litigation: untested and uncertain litigation strategies underpin patents protecting multibillion-dollar pharmaceuticals. B.U.J Sci & Tech L. 2013;191:194–214. Available from: https://www.bu.edu/jostl/files/2015/02/Metcalf_Legal_Update.pdf. *
- Patent Act, RSC, 1985, c P–4.
- Patent Rules, SOR/96–423.
- Minerals Separation North American Corp v. Noranda Mines, Ltd (1947), 12 CPR (1st), 102 (Ex Ct).
- Société des Usines Chimiques Rhone-Poulenc et al v. Jules R Gilbert Ltd et al (1968), 55 CPR (1st), 207 (SCC).
- Wandscheer et al v. Sicard Limitée (1947), 8 CPR (1st), 35 (SCC).
- Re Immunex Corp Patent App No 583,988 (2010), 89 CPR 9 (4th) 34 (PAB).
- Patent Office. Manual of Patent Office Practice. Canadian Intellectual Property Office. Ottawa-Gatineau. 2016 Mar 3. [cited 2016 May 1]. Available from: https://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00720.html.
- Re The New York Blood Center Inc, Patent App. No 2,308,623, CD 1323(PAB). [cited 2016 May 1]. Available from: http://patents.ic.gc.ca/opic-cipo/comdec/eng/decision/1323/summary.html?query=1323+%3Cin%3E+comdecnumber&start=1.
- Re Immunex Corporation, Patent App. No 1,341,611, CD1302 (PAB). [cited 2016 May 1]. Available from: http://www.ic.gc.ca/opic-cipo/comdec/eng/decision/1302/summary.html?query=1302+%3Cin%3E+comdecnumber&num=&pedisable=true.
- Re Sloan-Kettering Institute for Cancer Research, Patent App. No 2,072,017 (2009), 82 CPR (4th) 33 (PAB) [CD 1296]. [cited 2016 May 1]. Available from: http://patents.ic.gc.ca/opic-cipo/comdec/eng/decision/1296/summary.html?query=1296+%3Cin%3E+comdecnumber&start=1.
- Re Chugai Seiyaku and Kabushiki Kaisha, Patent App. No 2,451,493, (2016) (PAB) [CD 1398; Kaisha]. [cited 2016 Jun 1]. Available from: http://patents.ic.gc.ca/opic-cipo/comdec/eng/decision/1398/summary.html?query=1398+%3Cin%3E+comdecnumber&start=1. *
- AbbVie Corporation v. Janssen Inc, 2014 FC 55.
- Salfeld JG, Roguska M, Paskind M, et al., inventors; Abbvie Deutschland Gmbh & Co. Kg., assignee. Human antibodies that bind human IL-12 and methods for producing. Canadian patent 2,365,281. 2000 Mar 24 [ ‘281 Patent].
- AbbVie Deutschland GmbH v. Janssen Biotech, Inc, No 2013–1338 (Fed Cir 2014).
- Janssen Inc v. AbbVie Corporation, 2014 FCA 242.
- Docket T-1310-09, Federal Court of Canada – Court Files – Proceedings Queries, [cited 2016 May 1]. Available from: http://cas-cdc-www02.cas-satj.gc.ca/portal/page/portal/fc_cf_en/Index.
- Abbott GmbH & Co v. Centocor Ortho Biotech, Inc (2013), 971 F Supp 2d 171.
- Global Patent Index [Internet]. EU: European Patent Office. Legal status: EP No 2,168,984. [cited 19 Aug 2016]. Available from: https://data.epo.org/gpi/EP2168984B1-Human-antibodies-that-bind-human-IL-12-and-methods-for-producing.
- T 2019/14 of 22 September 2015.
- 35 USC §112 (a).
- 2163 Guidelines for the Examination of Patent Applications Under the 35 USC 112(a) or Pre-AIA 35 USC 112, para 1, “Written Description” Requirement [R-07.2015]. USPTO. 2015 Apr 11, Available from: https://www.uspto.gov/web/offices/pac/mpep/s2163.html [ USPTO Guidelines].
- Moba, BV v. Diamond Automation, Inc, 325 F 3d 1306 at 1319, 66 USPQ2d 1429 (Fed Cir 2003).
- Centocor Ortho Biotech, Inc v. Abbott Laboratories, 636 F 3d 1341 (Fed Cir 2011) [ Centocor].
- Enzo Biochem, Inc v. Gen-Probe, Inc, 323 F 3d (Fed Cir 2002).
- Noelle v. Lederman, 355 F 3d 1343 (Fed Cir 2004).
- Salfeld JG, Roguska M, Paskind M, et al., Inventors; Abbott Gmbh & Co. Kg., assignee. Human antibodies that bind human IL-12 and methods for producing. US Patent 6,914,128. 2000 Mar 24.
- Salfeld JG, Roguska M, Paskind M, et al., Inventors; Abbott Gmbh & Co. Kg., assignee. Human antibodies that bind human IL-12. US Patent 7,504,485. 1999 Mar 25.
- Abbott GmbH & Co et al v. Centocor Ortho Biotech Inc et al, No 09-11340, ECF No 400 (D Mass 2012).
- Le J, Vilcek J, Daddona P, et al., Inventors; Centocor, Inc., assignee. Recombinant A2-specific TNF.alpha specific antibodies. US Patent 7,070,775. 2002 Jul 18.
- Janeway CA, Travers P, Walpart M, et al. Immunobiology: the immune system in health and disease. 5th. New York (NY): Garland Science; 2001.
- Guidance Protecting Your Patent Abroad. UK Intellectual Property Office. 2016 Feb 22. [cited 2016 May 1]. Available from: https://www.gov.uk/government/publications/protecting-your-uk-intellectual-property-abroad/protecting-your-patent-abroad.
- The European Patent Convention, 1973, as revised in 2013.
- Patents Act 1977 (as amended), 1 October 2014.
- Asahi Kasei Kogyo KK’s Application, [1991] RPC 485.
- T 0735/00 (Anti-CRP antibodies/IATRON LABORATORIES, INC.) of 23.3.2004. [cited 2016 May 1]. Available from: http://www.epo.org/law-practice/case-law-appeals/recent/t000735eu1.html.
- Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the Intellectual Property Office. Intellectual Property Office. 2013. [cited 2016 May 1]. Available from: https://www.gov.uk/government/publications/examining-patent-applications-for-biotechnological-inventions.
- Level of disclosure required for antibodies. European Patent Office. 2013 Oct 1. [cited 2016 May 1]. Available from: http://www.epo.org/law-practice/legal-texts/html/caselaw/2016/e/clr_ii_c_6_3.htm. **
- Eli Lilly v. Janssen Alzheimer Immunotherapy, [2013] EWHC 1737 (Pat), [2014] RPC 1.
- Schenk DB, Inventor; Janssen Alzheimer Immunotherapy, assignee. Prevention and treatment of amyloidogenic disease. European Patent 1,994,937. 1997 Dec 2.
- Legal status: EP1994937. European Patent Register. 2016 Aug 19. Available from: https://register.epo.org/.
- Schenk DB, Inventor; Neuralab Limited, assignee. Prevention and treatment of amyloidogenic disease. US Patent 6,808,712. 1997 Dec 2.
- Schenk DB, Inventor; Neuralab Limited, assignee. Prevention and treatment of amyloidogenic disease. US Patent 6,982,084. 1997 Dec 2.
- Schenk DB, Inventor; Janssen Alzheimer Immunotherapy, assignee. Preventing and Treatment of Amyloidogenic Disease. Canadian patent 2,312,920. 2016 Jul 12.
- Lilly Announces Detailed Results of Solanezumab Phase 3 EXPEDITION3 Study at the Clinical Trials on Alzheimer’s Disease (CTAD) 2016 Meeting. The Province. 2016 Dec 8. [cited 2017 Jan 1]. Available from: http://www.theprovince.com/business/cnw/release.html?rkey=20161208C5460&filter=4007.
- Regeneron Pharmaceuticals Inc v. Genentech Inc, [2013] EWCA Civ 93.
- Eli Lilly & Co v. Human Genome Sciences Inc, [2012] EWCA Civ 1185.
- Ferrara N, Kim KJ, Inventors; Genentech, Inc., assignee. Use of Vascular endothelial cell growth factor antagonists. European Patent 1,238,986. 1992 Oct 28.
- Human Genome Sciences v. Eli Lilly, [2011] UKSC 51.
- Yu GL, Ebner R, Ni J, Inventors; Human Genome Sciences, Inc., assignee. NEUTROKINE alpha. European Patent 0,939,804. 1996 Oct 25.
- Cremers K, Ernicke M, Gaessler F, et al. Patent litigation in Europe. Eur J Law Econ. 2016 Feb 19. doi: 10.1007/s10657-016-9529-0. *