Improvement Patenting in Pharmaceuticals

1
Improvement Patenting in Pharmaceuticals
Innovative? Or Anti-innovative?Hyewon AhnMIPLC
PhD CandidateSixth Advanced Research Forum on
Intellectual Property Rights WIPO, 2012
Munich Intellectual Property Law Center (MIPLC)
2
Contents

• Background
• Topic of the Research
• Thesis of the Research
• Issues before Granting Patents
• Issues after Granting Patents
• Conclusion - preliminary

3
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.

4
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.

5
A. Background

• Characteristics of Pharmaceutical Industry
• Costly lengthy RD 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

6
A. Background

• RD, A long and costly Process
• Source ABPI, 2011, 10

7
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.

8
A. Background

• Changes over last 10 years
• Decreased RD productivity dearth of new medical
  entities (originals)
• Patent cliffs on the blockbusters (e.g. the
  basic patent for Lipitor expired 2011)
• Frequent MAs between originator companies and
  SMEs and/or generic companies
• Life cycle management, me-too or slightly
  me-better drugs
• Improvement Inventions?

9
A. Background

• Global RD expenditure, development times, global
  pharmaceutical sales and new molecular entity
  output in 1999-2009
• Source CMR International (2010 FactBook) IMS
  Health

10
B. Topic of the Research

• Is allowing improvement patenting in
  pharmaceutical field anti-innovative?
• If so, what can patent law do about it?

11
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 completeor
  better advance or increase in value or
  excellence
• Selection the action of selecting or choosing
  out the fact of being selected or chosen

12
B. Topic of the Research

• Is allowing improvement patenting
  anti-innovative? If so, what can patent law do
  about it?
• Improvement patenting in pharmaNew 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

13
B. Topic of the Research

• Examples of Improvement Inventions in Pharma

14
B. Topic of the Research

• Examples of Selection Inventions in Pharma

15
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)

16
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)

17
D. Issues before Granting Patents

• Novelty

18
D. Issues before Granting Patents

• 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

19
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)

20
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.

21
Thank you for your attention
hyewon.ahn_at_miplc.de