munich intellectual property law center (miplc)
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Munich Intellectual Property Law Center (MIPLC). Improvement Patenting in Pharmaceuticals – Innovative? Or Anti-innovative? Hyewon Ahn MIPLC PhD Candidate Sixth Advanced Research Forum on Intellectual Property Rights WIPO, 2012. Contents. Background Topic of the Research - PowerPoint PPT PresentationTRANSCRIPT
Munich Intellectual Property Law Center (MIPLC)
Improvement Patenting in Pharmaceuticals –
Innovative? Or Anti-innovative?Hyewon Ahn
MIPLC PhD Candidate
Sixth Advanced Research Forum on Intellectual Property Rights WIPO, 2012
A. Background
B. Topic of the Research
C. Thesis of the Research
D. Issues before Granting Patents
E. Issues after Granting Patents
F. Conclusion - preliminary
Contents
Pharmaceutical Products
Originals :
original drug, innovative drug, brand-name drug, reference listed
drug
Generics:
a drug product that is comparable to brand/reference listed drug
product in dosage form, strength, route of administration, quality
and performance characteristics, and intended use.
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A. Background
31. 05. 2012 Hyewon Ahn, MIPLC
Basic / Improvement Inventions
Basic invention:
a breakthrough invention providing with the roots and routes for
future inventions, such as improvements, applications, and so on,
and bringing out the cumulative innovations.
Improved invention:
an invention as when the improvement inventor cannot innovate
until the first inventor has made the basic invention.
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A. Background
31. 05. 2012 Hyewon Ahn, MIPLC
Characteristics of Pharmaceutical Industry
Costly & lengthy R&D procedure on Innovation v. negligible ones on
Imitation
Information rich molecules
Tremendous risks based on scientific, regulatory, & economic
uncertainties on Innovation (“Originals”) v. much reduced uncertainty
on Imitation (“Generics”)
Disconnection of choosers and payers of product
Patent Term Extension & Data Exclusivity
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A. Background
31. 05. 2012 Hyewon Ahn, MIPLC
R&D, A long and costly Process
*Source: ABPI, 2011, 10
A. Background
631. 05. 2012 Hyewon Ahn, MIPLC
Patent Term Extension
The period which can be applied and granted, to compensate for the term
which needed to obtain regulatory market approvals (MAs) by authorities of
new products for the pharmaceuticals & agrochemicals
Data Exclusivity
The period during which the data of the original marketing authorization
holder relating to (pre-) clinical tests to prove safety & efficacy of a new drug
is protected, and generic applicant may not refer to the above data in their
own applications of MAs.
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A. Background
31. 05. 2012 Hyewon Ahn, MIPLC
Changes over last 10 years
Decreased R&D productivity: dearth of new medical entities (originals)
Patent cliffs on the blockbusters (e.g.: the basic patent for Lipitor expired 2011)
Frequent M&As between ‘originator’ companies and SMEs and/or ‘generic’ companies
Life cycle management, me-too or slightly me-better drugs
“Improvement” Inventions?
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A. Background
31. 05. 2012 Hyewon Ahn, MIPLC
Global R&D expenditure, development times, global pharmaceutical sales and new molecular entity output in 1999-2009
*Source: CMR International (2010 FactBook) & IMS Health
A. Background
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B. Topic of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
“Is allowing improvement patenting in
pharmaceutical field anti-innovative?
If so, what can patent law do about it?”
“Is allowing improvement patenting anti-innovative? If so,
what can patent law do about it?”
Definition of Improvement Improvement: the action or process of enhancing, making or
becoming greater or more complete…or better; advance or
increase in value or excellence …
Selection: the action of selecting or choosing out; the fact of being
selected or chosen
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B. Topic of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
“Is allowing improvement patenting anti-innovative? If so,
what can patent law do about it?”
Improvement patenting in pharma:“New from Old Drug” Improvement inventions: Esters & salts, prodrugs, formulations,
combinations of active ingredients, new use/ new method of treatment
Selection inventions: genus/species, pharmacokinetic profiles,
purified compound such as polymorph, metabolites, and optical
isomers
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B. Topic of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
Examples of Improvement Inventions in Pharma
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B. Topic of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
Improvement Inventions
Aspirin Formulation CombinationNew Use
Examples of Selection Inventions in Pharma
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B. Topic of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
Olanzapine (R)-enantiomerForm V
Can Improvement Patenting in Pharmaceuticals Hamper the innovation?
- Lowered bar of patentability requirements for these patents- Invitation to the improvement patents?
Provide significant therapeutic advantage over Original?- Some benefits for a small subset of the patient population
Hamper the competition in this field?- Incremental advantage v new monopoly, inter alia monopoly cost- Separate patent term extensions & data exclusivities to
improvement patents (esp., by same holder as basic patentee)
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C. Thesis of the Research
31. 05. 2012 Hyewon Ahn, MIPLC
Patentable Subject Matter
E.g., Dosage Regime
- Treatment of same illness of same medication in 0.5-1.0mg is
patentable even if the sole distinguishing feature over the prior
art (in a dose of 5mg) is this new dosage regime (UK, DE)
- “Once per day prior to sleep” of a well-know medication to treat
the same illness is patentable subject matter (EPO)
- Dosage regime is not patentable since it is “plainly not” a second
medical indication (FR, 1st instance)
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D. Issues before Granting Patents
31. 05. 2012 Hyewon Ahn, MIPLC
Novelty
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D. Issues before Granting Patents
31. 05. 2012 Hyewon Ahn, MIPLC
Olanzapine (R)-enantiomerForm V
Obviousness
E.g., Despite of the motivations, such as FDA strategies or state-
of-the-art progresses to resolve the racemate, an enantiomer is
not obvious because of the difficulty of separation (DE, US, UK)
Sufficiency-enablement requirement
Enablement requirement for the purpose of sufficiency
Enablement requirement for the purpose of anticipation
Implication of this discrepancy
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D. Issues before Granting Patents
31. 05. 2012 Hyewon Ahn, MIPLC
Scope of Patents
E.g., the scope of species selection invention is overlapping with
the scope of basic invention, so far as both patents are valid.
Length of Patents
E.g., the previously granted SPC on a racemic compound
(Ofloxacin) did not hinder from granting an SPC for the enantiomer
(Levofloxacin) (UK)
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E. Issues after Granting Patents
31. 05. 2012 Hyewon Ahn, MIPLC
Yes, it is anti-innovative and counter-productive in the sense that it
adds incentives to move forward to improvement inventions than
to innovative inventions.
Clearer rules on patentability requirements of improvement
patents, on scope of basic and improvement patent rights, on
granting SPCs on improvement patents, and on utilisation of
improvement patents would reduce legal uncertainties in this area.
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F. Conclusion - preliminary
31. 05. 2012 Hyewon Ahn, MIPLC
Thank you for your attention