From blockbusters to biosimilars – the Patent Perspective Dr. Thomas Friede Partner Patentanwalt &...
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Transcript of From blockbusters to biosimilars – the Patent Perspective Dr. Thomas Friede Partner Patentanwalt &...
From blockbusters to biosimilars – the Patent Perspective
Dr. Thomas Friede Partner Patentanwalt & European Patent Attorney
2nd C5 Forum Biosimilars 2012
2nd C5 Forum Biosimilars 2012 2
Important biologics patents expire
Pharmaceutical Active ingredient Year of expiry
Lantus Insulin 2014
Remicade (infliximab) Monoclonal antibody 2014
Herceptin Monoclonal antibody 2014
NovoRapid/NovoLog Insulin 2014
Rituximab Monoclonal antibody 2014
Pegfilgrastim G-CSF 2015
Gardasil Vaccine (HPV) 2015
Synagis Monoclonal antibody 2015
Erbitux (Cetuximab) Monoclonal antibody 2016
Humira Monoclonal antibody 2018
Lucentis Monoclonal antibody 2018
Avastin Monoclonal antibody 2019
2nd C5 Forum Biosimilars 2012 3
Biosimilars approved in EuropeBiosimilar Active ingredient Year of grant
Omnitrope Somatotropin 2006
Valtropin Somatotropin 2006
Binocrit Epoetin Alpha 2007
Epoetin alpha Hexal Epoetin Alpha 2007
Abseamed Epoetin Alpha 2007
Retacrit Epoetin zeta 2007
Silapo Epoetin zeta 2007
Ratiograstim Filgrastim 2008
Biograstim Filgrastim 2008
Tevagrastim Filgrastim 2009
Filgrastim (Sandoz) Filgrastim 2009
Filgrastim Hexal Filgrastim 2009
Zarzio Filgrastim 2009
Nivestim Filgrastim 2010
2nd C5 Forum Biosimilars 2012 4
Biosimilars under current review by EMA
Common name
Therapeutic area Number of applications
Originator product
Originator company
Filgrastim Immunostimulant (cancer/neutropenia)
1 Neupogen Amgen
Follitropin alpha
Sex hormones and modulators of the genital system (IVF)
1 Gonal-F Merck Serono
Infliximab Immunosuppressant (arthritis)
2 Remicade Merck/Johnson & Johnson
Insulin human
Diabetes 3 Humalog Eli Lilly
Total 7
2nd C5 Forum Biosimilars 2012 5
Life cycle management - Evergreening
First generation: product patent
Second generation: process patents, derivatives, formulations, different medical uses
Decision of the Enlarged Board of Appeal G2/08 confirms the patentability of dosage regime
However: DE Federal Supreme Court „Carvedilol II“
December 19, 2006
dosage regime cannot be considered for novelty inventive step
FR Decision of the Tribunal de Grande Instance Paris on September 28, 2010 „Actavis v. Merck“
dosage regime feature violates Art. 53c) EPC
2nd C5 Forum Biosimilars 2012 6
Life cycle management – Evergreening (II)
Separate prosecution of different aspects of the same invention in parent and divisional is desirable (compounds, modes of administration, medical indications)
However: T 307/03: Prohibition of double patenting even if the compound claimed in the parent is only encompassed by the scope of the divisional application
Solution: Introduction of a Disclaimer
Decision G 2/10 of the EPO Enlarged Board of Appeal, Point 4 of the Reasons: A disclaimer is not only admissible based on prior art under Art. 54(2) and 54(3) EPC but also in other situations such as for non-patentability related reasons
2nd C5 Forum Biosimilars 2012 7
Industrial Applicability- The Principles (i) The patent must disclose "a practical application" and "some profitable use" for the claimed substance, so that the ensuing monopoly "can be expected [to lead to] some … commercial benefit" (T 0870/04, para 4, T 0898/05, paras 2 and 4);
(ii) A "concrete benefit", namely the invention's "use … in industrial practice" must be "derivable directly from the description", coupled with common general knowledge (T 0898/05, para 6, T 0604/04, para 15);
(iii) A merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do (T 0870/04, para 21 and T 0898/05, paras 6 and 21);
(iv) The patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden", or having to carry out "a research programme" (T 0604/04, para 22, T 0898/05, para 6)
2nd C5 Forum Biosimilars 2012 8
Industrial Applicability (II)
(v) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras 21 and 31, T 1452/06, para 5);
(vi) A "plausible" or "reasonably credible" claimed use, or an "educated guess", can suffice (T 1329/04, paras 6 and 11, T 0640/04, para 6, T 0898/05, paras 8, 21, 27 and 31, T 1452/06, para 6, T 1165/06 para 25);
(vii) Such plausibility can be assisted by being confirmed by "later evidence", although later evidence on its own will not do
(T 1329/04, para 12, T 0898/05, para 24, T 1452/06, para 6, T 1165/06, para 25)
2nd C5 Forum Biosimilars 2012 9
Broad claims
• disclosure of a concept fit for generalisation required1
Examiner has to substantiate reasons
why he believes the effect cannot be achieved →
objections may be based on common general
knowledge or prior art
no general rules
each case must be assessed on ist own merits2
1 T 435/91, OJ EPO 1995, 188.
2 See T 694/92, OJ EPO 1997, 408 concerning a plant patent.
2nd C5 Forum Biosimilars 2012 10
Harmonization of national Case law with EPO Case law
UK Supreme Court HGS v Eli Lilly of November 2, 2011:
“In a number of recent decisions of the House of Lords, attention has been
drawn to "the importance of UK patent law aligning itself, so far as possible, with
the jurisprudence of the EPO (and especially decisions of its Enlarged Boards of
Appeal)", to quote Lord Walker in Generics (UK) Ltd v H Lundbeck A/S
[2009] UKHL 12; [2009] RPC 13, para 35.”
German Federal Supreme Court Xa ZB 10/09 of April 15, 2010:
(“Walzenformgebungsmaschine”):
“German courts have to comply with decisions handed down by the courts of the
European Patent Office or by courts in other EPC contracting states and which
essentially concern the same issue, and if necessary they have to address the
grounds which led to a divergent result in the prior decision.”
2nd C5 Forum Biosimilars 2012 11
Scope of Biotech Patents
Scope of EP patents governed by Art. 69 EPC and protocol on the interpretation of Art. 69 EPC
However: Interpretation by national Case Law
Germany:
- known for broad claim interpretation (function-oriented approach)
- applying the doctrine of equivalents
2nd C5 Forum Biosimilars 2012 12
Scope of Biotech Patents
The German Federal Supreme Court has developed three questions for the determination of equivalency:
1. Does the modified embodiment solve the problem underlying
the invention with means that have objectively the same technical effect?
2. Was the person skilled in the art, using his specialist
knowledge, able to find the modified means at the priority date as having the same effect?
3. Are the considerations that the person skilled in the art had to
apply oriented to the technical teaching of the patent claim in such a way that the person skilled in the art took the modified embodiment into account as being an equivalent solution?
2nd C5 Forum Biosimilars 2012 13
Scope of Biotech Patents
Federal Supreme Court X ZB 12/00 of March 12, 2002 („Custodiol I“)
The indication of numerically defined ranges is generally binding. Figures outside the claimed range are not considered to be equivalent.
Exception from the rule: tolerances due to limits in working precision
2nd C5 Forum Biosimilars 2012 14
Scope of Biotech Patents
Federal Supreme Court X ZR 16/09 of May 10, 2011 („Okklusionsvorrichtung“):
Where the description discloses several ways of achieving a
specific technical effect, as a rule, patent infringement by equivalent means is to
be denied if only one of these ways is incorporated in the claim.
Federal Supreme Court X ZR 69/10 of September 13, 2011 („Diglycidverbindung“):
at least two requirements would have to be met for infringement
under the doctrine of equivalence: (1) the specific effects of the variant are in
accord with the claimed solution, and (2) the variant differs from the
alternative merely outlined in the description but not in the claims in a similar
fashion as the claimed solution differs from it.
2nd C5 Forum Biosimilars 2012 15
Recent Biotech Patent Decisions of German Courts – thermostable DNA polymerase OLG Düsseldorf of January 14, 2010
I-2 U 69/08
Claim 1 of the Patent relates to a thermostable DNA polymerase having a molecular weight of 86.000 to 90.000 Da as determined by SDS page.
The attacked embodiment: DNA polymerase having a molecular weight of 85.000 Da
The attacked DNA polymerase was found not to infringe the patent.
Court ruling: No equivalent infringement having regard to the Federal Supreme Court Schneidmesser and Custodiol decisions which rule that numerical ranges in claims are binding.
2nd C5 Forum Biosimilars 2012 16
Recent Biotech Patent Decisions of German Courts – Ranibizumab
LG Düsseldorf of November 18, 2011
4a O 143/10: MedImmune vs. Novartis (Ranibizumab)
Representatives MedImmune: Johannes Heselberger, Thomas Friede
Litigation also in UK, FR, CH and NL
Claim 1 of the Patent relates to a method comprising Phage Display Technology
Ranibizumab is a Fab fragment specific for VEGF used for the treatment of AMD (age-related macula degeneration)
Annual Ranibizumab sales (Europe): US-$ 1.3 billion
Patent found to be infringed by import and sale of immediate product of the process
2nd C5 Forum Biosimilars 2012 17
Recent Biotech Patent Decisions of German Courts - Ranibizumab
Ranibizumab differs from the binding molecule actually obtained by the process by several substitutions introduced after the phage display step.
However:
Claim covers binding molecule, fragment or derivative with binding specificity for the target
=> Claim encompasses Ranibizumab.
2nd C5 Forum Biosimilars 2012 18
Recent Biotech Patent Decisions of German Courts - Ranibizumab
Narrowing claim construction by the Defendants:
The Defendants argued that the core of the invention resides in a screening method which does not generate a product.
Court reasoning:
The claimed method is a manufacturing method since it comprises manufacturing steps.
2nd C5 Forum Biosimilars 2012 19
Thank you for your attention !
Questions?
Dr. Thomas Friede
BARDEHLE PAGENBERG
Prinzregentenplatz 7
81675 München
www.bardehle.com