Transcript A. Background

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
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
A. Background
 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
 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
 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
 R&D, A long and costly Process
*Source: ABPI, 2011, 10
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A. Background
 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
 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
 Global R&D expenditure, development times, global
pharmaceutical sales and new molecular entity output in 1999-2009
*Source: CMR International (2010 FactBook) & IMS Health
B. Topic of the Research
“Is allowing improvement patenting in
pharmaceutical field anti-innovative?
If so, what can patent law do about it?”
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B. Topic of the Research
 “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
 “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
 Examples of Improvement Inventions in Pharma
Basic Invention
Aspirin
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Improvement Inventions
New Use
Formulation
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Combination
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B. Topic of the Research
 Examples of Selection Inventions in Pharma
Genus/Species
Olanzapine
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Polymorph
Form V
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Enantiomer
(R)-enantiomer
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C. Thesis of the Research
 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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D. Issues before Granting Patents
 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
 Novelty
Genus/Species
Olanzapine
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Polymorph
Form V
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Enantiomer
(R)-enantiomer
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D. Issues before Granting Patents
 Obviousness
 E.g., Despite of the motivations, such as FDA strategies or stateof-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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E. Issues after Granting Patents
 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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F. Conclusion - preliminary
 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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Thank you for your attention
[email protected]