1. 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

2. 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

3.  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. 3 A. Background 31. 05. 2012Hyewon Ahn, MIPLC

4.  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. 4 A. Background 31. 05. 2012Hyewon Ahn, MIPLC

5.  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 5 A. Background 31. 05. 2012Hyewon Ahn, MIPLC

6.  R&D, A long and costly Process *Source: ABPI, 2011, 10 A. Background 631. 05. 2012Hyewon Ahn, MIPLC

7.  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. 7 A. Background 31. 05. 2012Hyewon Ahn, MIPLC

8.  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? 8 A. Background 31. 05. 2012Hyewon Ahn, MIPLC

9.  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

10. 10 B. Topic of the Research 31. 05. 2012Hyewon Ahn, MIPLC “Is allowing improvement patenting in pharmaceutical field anti-innovative? If so, what can patent law do about it?”

11.  “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 11 B. Topic of the Research 31. 05. 2012Hyewon Ahn, MIPLC

12.  “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 12 B. Topic of the Research 31. 05. 2012Hyewon Ahn, MIPLC

13.  Examples of Improvement Inventions in Pharma 13 B. Topic of the Research 31. 05. 2012Hyewon Ahn, MIPLC Improvement InventionsBasic Invention Aspirin Formulation Combination New Use

14.  Examples of Selection Inventions in Pharma 14 B. Topic of the Research 31. 05. 2012Hyewon Ahn, MIPLC Genus/Species Polymorph Enantiomer Olanzapine (R)-enantiomer Form V

15.  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) 15 C. Thesis of the Research 31. 05. 2012Hyewon Ahn, MIPLC

16.  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) 16 D. Issues before Granting Patents 31. 05. 2012Hyewon Ahn, MIPLC

17.  Novelty 17 D. Issues before Granting Patents 31. 05. 2012Hyewon Ahn, MIPLC Genus/Species Polymorph Enantiomer Olanzapine (R)-enantiomer Form V

18.  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 18 D. Issues before Granting Patents 31. 05. 2012Hyewon Ahn, MIPLC

19.  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) 19 E. Issues after Granting Patents 31. 05. 2012Hyewon Ahn, MIPLC

20.  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. 20 F. Conclusion - preliminary 31. 05. 2012Hyewon Ahn, MIPLC

21. Thank you for your attention hyewon.ahn@miplc.de