Hint: A Little (2015)

Transcription

IS YOUR MEDICAL TREATMENT CLAIM MORE PATENTABLE NOW? HINT: A
LITTLE
*
GABRIELLE MOISAN
ROBIC, LLP
LAWYERS, PATENT AND TRADE-MARK AGENTS
In the pharmaceutical field, when both the molecule and the use are known and the
invention is only about the administration mode or the dosage range, it might be
difficult to get a patent in Canada.
In fact, The Patent Act defines an “invention” in section 2 as:
any new and useful art, process, machine, manufacture or
composition of matter, or any new and useful improvement in any art,
process, machine, manufacture or composition of matter.
Case law has excluded medical methods of treatment on the human or animal body
from this definition, on the grounds that they were not processes and that they would
compromise the work of healthcare professionals and therefore would also
compromise the patient care. More particularly, claims which describe an active step
of surgery or of administration and/or provide a therapeutic benefit are rejected,
whereas claims directed to cosmetic or diagnostic methods, or related to natural
states considered non pathological like pregnancy, baldness, wrinkles and ageing
are allowed.
These claims had to be replaced with use claims, without any step of administration:
•
Use of product X for treating disease Y;
•
Use of product X for the manufacture of a medicament for treating disease Y;
•
Product X for treating disease Y.
However, when the claims describe a dosage range or a range of administration,
they are rejected if a healthcare professional must not only decide whether or not to
prescribe a treatment to a patient (“what”), but must also exercise professional
judgement (“how”: what dosage, for how long, according to the patient’s profile and
his response to treatment). Case law requires that the dosage and the calendar of
administration be fixed. To obtain patentable claims, sometimes many claims must
be drafted, each with a specific dosage and calendar, such as:
Claim 1: 10mg for 10 days, then 20mg for 5 days
© CIPS, 2015.
*
From ROBIC, LLP, a multidisciplinary firm of Lawyers, and Patent and Trade-mark Agents. Published
in the Spring 2015 (Vol. 18, no. 4) Newsletter of the firm. Publication 068.194E.
ROBIC, LLP
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2
Claim 2: 10 mg for 5 days, then 20mg for 10 days.
In the judgement of January 20th 2015 of AbbVie Biotechnology Ltd v. Canada [2014
FC 1251], the Federal Court overturned the Commissioner’s decision to reject the
patent application 2,385,745 on the grounds that the claims were directed towards
methods of treatment, with an indeterminate period of administration, and ordered
rather that the claims be amended to become patentable before being sent to the
examiner. The patent was issued February 17th 2015 with the following claim 13, in
the form of use and an administration every two weeks:
13. Use of an isolated human anti-TNFα antibody wherein said
antibody (a) comprises a light chain variable region (LCVR)
comprising a CDR3 domain comprising the amino acid sequence of
SEQ ID NO: 3, a CDR2 domain comprising the amino acid sequence
of SEQ ID NO: 5, and a CDR1 domain comprising the amino acid
sequence of SEQ ID NO: 7; and (b) comprises a heavy chain
variable region (HCVR) comprising a CDR3 domain comprising the
amino acid sequence of SEQ ID NO: 4, a CDR2 domain comprising
the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain
comprising the amino acid sequence of SEQ ID NO: 8; in the
manufacture of a medicament for treating an arthritic disease or an
inflammatory bowel disease in a human subject, wherein said
medicament is adapted for subcutaneous administration and wherein
the dosage is 40 mg according to a continuous schedule having an
every other week dosing interval of 14 days.
The
CIPO
has
prepared
practice
notice
PN
2015-012
[http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03916.html]
for
examiners following the Federal Court’s decision and also provided some examples
[http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03919.html]. If the
claim’s purpose is to answer the “what”, as in what is needed to treat a patient (a
compound, a molecule, a composition, a formulation, a dosing unit, a sub-population
of patients, a distinct population of patients), it’s patentable. If the claim’s purpose
answers the “how”, and informs the medical professional as to how to treat the
patient (a dosage range, a large/vague administration calendar) requiring both his
professional skills and judgement, the claim is not patentable.
In conclusion, the claim must describe the use of a saleable and isolatable product as
much as possible. The patent agent community welcomes this decision with relief,
since a growing number of inventions consist precisely in new dosages and/or
administration calendars, and it is unfortunate to see these inventions be protected
all around the world, yet not in Canada. This decision represents a step in the right
direction.
ROBIC, LLP
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3
ROBIC, LLP
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4
Pour des services de conseils dans le domaine de la propriété
intellectuelle et des technologies de l'information et des communications
(incluant les services d’agents de brevets et de marques de commerce)
de même que des services juridiques.
ROBIC, un groupe d'avocats et d'agents de brevets et de marques de
commerce voué depuis 1892 à la protection et à la valorisation de la propriété
intellectuelle dans tous les domaines: brevets, dessins industriels et modèles
utilitaires; marques de commerce, marques de certification et appellations
d'origine; droits d'auteur, propriété littéraire et artistique, droits voisins et de
l'artiste interprète; informatique, logiciels et circuits intégrés; biotechnologies,
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concurrence; licences, franchises et transferts de technologies; commerce
électronique, distribution et droit des affaires; marquage, publicité et
étiquetage; poursuite, litige et arbitrage; vérification diligente et audit. ROBIC,
a group of lawyers and of patent and trademark agents dedicated since 1892 to
the protection and the valorization of all fields of intellectual property: patents,
industrial designs and utility patents; trademarks, certification marks and
indications of origin; copyright and entertainment law, artists and performers,
neighbouring rights; computer, software and integrated circuits;
biotechnologies, pharmaceuticals and plant breeders; trade secrets, knowhow, competition and anti-trust; licensing, franchising and technology
transfers; e-commerce, distribution and business law; marketing, publicity and
labelling; prosecution litigation and arbitration; due diligence. ®/MD
COPYRIGHTER TM/MC
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IL A TOUT DE MÊME FALLU L'INVENTER!
® MD
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LEGER ROBIC RICHARD ®/MD
NOS FENÊTRES GRANDES OUVERTES SUR LE MONDE DES AFFAIRES ®/MD
PATENTER®/MD
ou «R» ®/MD stylisé
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ou ROBIC +LAW +BUSINESS +SCIENCE +ART®/MD stylisé
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IDEAS TO THE WORLD ®/MD
Marques de commerce de ROBIC, S.E.N.C.R.L. pour ses services de
conseils dans le domaine de la propriété intellectuelle et des
technologies de l'information et des communications (incluant les
services d’agents de brevets et de marques de commerce) de même
que ses services juridiques
*************************************************************************************************
*
For services pertaining to intellectual property, technology and
communication law and related matters (including patent and trade-mark
agency services) as well as legal services.
ROBIC, un groupe d'avocats et d'agents de brevets et de marques de
commerce voué depuis 1892 à la protection et à la valorisation de la propriété
intellectuelle dans tous les domaines: brevets, dessins industriels et modèles
utilitaires; marques de commerce, marques de certification et appellations
d'origine; droits d'auteur, propriété littéraire et artistique, droits voisins et de
l'artiste interprète; informatique, logiciels et circuits intégrés; biotechnologies,
pharmaceutiques et obtentions végétales; secrets de commerce, know-how et
concurrence; licences, franchises et transferts de technologies; commerce
électronique, distribution et droit des affaires; marquage, publicité et
étiquetage; poursuite, litige et arbitrage; vérification diligente et audit. ROBIC,
ROBIC, LLP
www.robic.ca
[email protected]
MONTREAL
Tel.: +1 514 987-6242 Fax: +1 514 845-7874
QUEBEC
Tel.: +1 418 653-1888 Fax.: +1 418 653-0006
6
a group of lawyers and of patent and trademark agents dedicated since 1892 to
the protection and the valorization of all fields of intellectual property: patents,
industrial designs and utility patents; trademarks, certification marks and
indications of origin; copyright and entertainment law, artists and performers,
neighbouring rights; computer, software and integrated circuits;
biotechnologies, pharmaceuticals and plant breeders; trade secrets, knowhow, competition and anti-trust; licensing, franchising and technology
transfers; e-commerce, distribution and business law; marketing, publicity and
labelling; prosecution litigation and arbitration; due diligence. ®/MD
COPYRIGHTER TM/MC
IDEAS LIVE HERE ®/MD
IL A TOUT DE MÊME FALLU L'INVENTER!
® MD
/
LA MAÎTRISE DES INTANGIBLES ®/MD
LEGER ROBIC RICHARD ®/MD
NOS FENÊTRES GRANDES OUVERTES SUR LE MONDE DES AFFAIRES ®/MD
PATENTER®/MD
or stylizedR®/MD
ROBIC®/MD
or stylized ROBIC ++++®/MD
or stylized ROBIC + DROIT +AFFAIRES +SCIENCES +ARTS®/MD
or stylized ROBIC +LAW +BUSINESS +SCIENCE +ART®/MD
THE TRADEMARKER GROUP TM/MC
TRADEMARKER TM/MC
VOS IDÉES À LA PORTÉE DU MONDE , DES AFFAIRES À LA GRANDEUR DE
LA PLANÈTE®/MD
ROBIC, LLP
www.robic.ca
[email protected]
MONTREAL
Tel.: +1 514 987-6242 Fax: +1 514 845-7874
QUEBEC
Tel.: +1 418 653-1888 Fax.: +1 418 653-0006
7
YOUR BUSINESS IS THE WORLD OF IDEAS; OUR BUSINESS BRINGS YOUR
IDEAS TO THE WORLD ®/MD
Trade-marks of ROBIC, LLP for its services pertaining to intellectual
property, technology and communication law and related matters
(including patent and trade-mark agency services) as well as legal
services
ROBIC, LLP
www.robic.ca
[email protected]
MONTREAL
Tel.: +1 514 987-6242 Fax: +1 514 845-7874
QUEBEC
Tel.: +1 418 653-1888 Fax.: +1 418 653-0006

Hint: A Little (2015)

Transcription

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