Transcript Folie 1 - BARDEHLE PAGENBERG: Home

From blockbusters to biosimilars – the
Patent Perspective
Dr. Thomas Friede
Partner
Patentanwalt & European Patent Attorney
2nd C5 Forum Biosimilars 2012
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
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Biosimilars approved in Europe
Biosimilar
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
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Biosimilars under current review by EMA
Common Therapeutic area
name
Number of
applications
Originator
product
Originator
company
Filgrastim Immunostimulant
(cancer/neutropenia)
1
Neupogen
Amgen
Follitropin Sex hormones and
alpha
modulators of the
genital system (IVF)
1
Gonal-F
Merck Serono
Infliximab Immunosuppressant
(arthritis)
2
Remicade
Merck/Johnson &
Johnson
Insulin
human
3
Humalog
Eli Lilly
Diabetes
Total
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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
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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
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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)
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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)
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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.
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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.”
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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
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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?
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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
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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.
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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.
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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
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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.
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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.
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Thank you for your attention !
Questions?
Dr. Thomas Friede
BARDEHLE PAGENBERG
Prinzregentenplatz 7
81675 München
[email protected]
www.bardehle.com
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