This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor (TNF) biologics. TNF is the world’s most valuable target, with accumulated sales of TNF biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
Art. 54(5) EPC: paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.
2.
35 U.S.C. §287(c)(1): […] the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
3.
District Court Hamburg, Case No 315 O 24/15.
4.
StorzU., Extending the market exclusivity of therapeutic antibodies through dosage patents, MAbs8(5) (2016), 841–847.
5.
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), EMA/CHMp/BWp/247713/2012.
6.
Scientific Considerations in Demonstrating Biosimilarity to a Reference product – Guidance for Industry. FDA, April 2015.
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Decision [2016] EWCA Civ 780 of the England and Wales Court of Appeal.
8.
StorzU., Extending the market exclusivity of therapeutic antibodies through dosage patents, MAbs8(5) (2016), 841–847.
9.
US patent 6,171,586 B1 assigned to Genentech, published Jan 9, 2001.
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StorzU., The last Mohican of antibody(-like) compound patents, The Rhineland Biopatent Gazette2 (2016).
11.
Janssen vs. Celltrion/Pfizer, D Mass, 1:15-cv-10698 and 1:14-cv-11613.
12.
G.D. Searle LLC v, Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015).
13.
As reported by Steinar Madsen, Medical Director of the Norwegian Medicines Agency, at the CPhI Worldwide Pre-connect Congress in Madrid, Oct 2015.
14.
BlackstoneE.A. and JosephP.F., The Economics of Biosimilars, American Health & Drug Benefits6(8) (2013), 469–478.
15.
Samsung Bioepis’ biosimilar hits $100 mil. sales in Europe. The Korea Times, Jan 31, 2017.
16.
Biosimilar etanercept offered at 47% discount in Norway. GABI online, Feb 05, 2016.
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NHS list prices.
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Pfizer cuts price of Enbrel to match rival biosimilar drug. The Irish Times, Oct 25, 2016.
19.
Data provided by Global Sales Inc., UCB and J&J.
20.
According to an Amgen executive at Q3/2016 earnings conference call.
21.
Sandoz head: Embrel Biosimilar Erelzi won’t launch before 2018. FiercePharma, Jan 25, 2017.
