Munich Intellectual Property Law Center (MIPLC)

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.

3

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.

4

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

5

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.

7

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?

8

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

10

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

11

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

12

B. Topic of the Research

31. 05. 2012 Hyewon Ahn, MIPLC

Examples of Improvement Inventions in Pharma

13

B. Topic of the Research

31. 05. 2012 Hyewon Ahn, MIPLC

Improvement Inventions

Aspirin Formulation CombinationNew Use

Examples of Selection Inventions in Pharma

14

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)

15

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)

16

D. Issues before Granting Patents

31. 05. 2012 Hyewon Ahn, MIPLC

Novelty

17

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

18

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)

19

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.

20

F. Conclusion - preliminary

31. 05. 2012 Hyewon Ahn, MIPLC

Thank you for your attention

hyewon.ahn@miplc.de