1© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Original vs. Generic Products- Who is Right?

Latest developments in European IP Law affecting the Pharmaceutical Industry

Martin Schneider

„Evolvement of IPRs and its Management“ MarkPat.Org

Ahmedabad 09/10 February 2008

2© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Originals vs. Generics - Who is right?

IP assets, in particular patents, are important means for business success of pharmaceutical industry

Patents confer exclusivity on a certain invention by granting the right to the patentee to exclude others from utilization thereof for a certain period of time

Indispensable tool to ensure return on investment

Marketing approval necessary from Health Authorities (Europe):

MRP (Mutual Recognition Procedure) or

Centralized Procedure

Sufficient preclinical and clinical data needed to prove safety and efficacy

Time to market: may be about 7-10 years ( additional sheet)

Investment: 500 mio CHF and more for 1 single medicament

Return on Investment facilitated by Patent Term Extensions / SPCs

3© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Originals vs. Generics - Who is right?

Serious budget restrictions in public health care result in an increasing demand for cheap / affordable medicines

Generics industry specialised to fulfil this need

In some European countries market share on no. of prescription drug more than 50% (DE, UK, DK)

Lack of own research and development on the API cost efficient

Genercis can only be launched after patent expiry

Usually at least some test (bioequivalency) needed for marketing approval

If necessary tests can be performed only after patent expiry originators will practically benefit from a further monopoly beyond normal patent term

Consequence: generics industry might perform necessary tests abroad or delays product launch unless Use Exemptions / Bolar-type provisions provided

4© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Originals vs. Generics - Who is right?

Increased pressure to reduce prices of drugs - examples (Swiss Regulations):

• As from 1.1.2006 the franchise (towards social insurance refunding) for original products has been increased to 20 % in case there is an aequivalent generic product

• As from 1.1.2008: Generics will only be accepted in the „special list“ (that is refunded by social insurance) if they are 40 % cheaper than the corresponding original product

5© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Originals vs. Generics - Who is right?

6© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Originals vs. Generics - Who is right?

7© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Who is smarter?some Basics: Various Categories of Claims

Main categories: Drug substance (API, Active Pharmaceutical Ingredient) Combination of APIs Galenic formulation / pharmaceutical composition Medical use / treatment / indication (secondary use)

Further categories: Production process / method of making Biotechnological subject matter (gene, DNA, vector, cell line etc.) Bulk form (e.g. polymorph, crystal form) Research Tools, biological target Screening assay, diagnostic assay Device (e.g. band aid, injector)

8© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Who is smarter?Various categories of claims

Example 1 „IGF“ (2001) (Illi / Feldmann )

• Utilization of Growth Factors for the production of Medicaments (WO 00/00180)

• Sustained Release Composition comprising Insuline like Growth Factor (IGF) (WO 01/58426 A1)

• Biodegradable Osteosynthesis (US 6,214,008 B1)

Example 2 „applicators of eardrops“ (Illi / Feldmann)

9© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Who is smarter? Secondary use claim / pricing policy

Example „Finasterid“ (INN)

• Propecia ® : men‘s hair loss / enhance hair growth (once-a-day pill)

• Proscar ®: Benign Prostatic Hyperplasie

•

10© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Who is smarter?Search for barriers / opportunities

11© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – PTEs and SPCsPatent Term Extensions and Supplemental Protection Certificates

PTEs and SPCs introduced to compensate originator companies for time loss resulting from aspproval process

Available in many countries, e.g. US, European countries, Japan, Australia, Israel etc.

May be subject to certain conditions

Compensation for time necessary for obtaining Marketing Authorization (MA) when patentee cannot exploit the invention being the subject of the patent

PTEs / SPCs extremely important because they protect marketed products

Never goes beyond the protection of the patent on which it is based, i.e. confers the same rights as under the basic patent

12© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – PTEs and SPCsPatent Term Extensions and Supplemental Protection Certificates

EEC Regulation 1768/92 (pharmacueticals), EEC 1610/96 (agriculture); and natl. SPC in CH Confers at least 15 years of effective protection (i.e. up to 15 years protection after MA) Maximum duration of 5 years after patent expiry To be applied for countrywise within 6 months of the first Marketing Authorization in that country, or within 6 months of grant of patent, whatever is later Duration: Art. 13 of Regulation 1768/92

If time from filing of patent application to grant of first MA in the EC or EEA is less than 5 years: no SPCIf time is more than 10 years, SPC is capped at 5 yearsIf time is between 5 and 10 years, duration depends on the date of first MA in the EC

13© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Experimental use exemptionBolar type provisions of non infringement

Exemptions for certain activites as exception from otherwise infringment

„Experimental Use Exemptions“ usually to promote scientifc research, improvements of inventions etc.

In many jurisdictions not allowed if commercial intention

„Bolar-type provisions“: special type of use exemptions for activites related to obtain Marketing Authorizations from Health Authorities

US case Roche vs. Bolar / Wayman-Hatch Act 1984 (US)

Provides Patent Term Extensions for Originators, and Use Exemptions (e.g. for performing clinical tests to obtain marketing approval) for Generics Industries

14© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Experimental use exemptionSituation in Europe

Germany (Supreme Court Decisions Clinical Trials 1 and 2)

In Germany use exemption for activities providing new knowledge / insights

Regardless whether commercial or non-commercial intention

In CH introduction of Bolar-type provisions intended

EU (Directive 2004/27/EC)

Introduction of broad Bolar-type provisons for activites related to obtaining Marketing Authorization

No condition regarding provision of new knowledge

Opportunity for Generics businesses for early market entry

15© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Copyright Law – Data ExclusivitySituation in Europe

General

(see also European Generics Medicines Associations)

Data exclusivity guarantees additional market protection for originator pharmaceuticals by preventing health authorities from accepting applications for generic medicines during the period of exclusivity.

The effective period of market exclusivity gained by the originator company is the period of data exclusivity (currently 6 or 10 years) plus the time it takes to register and market the generic medicine — a further 1 to 3 years.

Data Exclusivity was introduced in 1987 to compensate for insufficient product patent protection in some countries. However, strong product patents are now available in all 27 EU Member States. The rules on data exclusivity have been changed in the new EU pharmaceutical laws adopted in 2004.

16© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Copyright Law – Data ExclusivitySituation in Europe

The new legal framework

17© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Patent Law – Filing strategies & costs

Filing and prosection costs, maintencance fees

Lifetime costs of 1 average pharmaceutical patent family:

About 500.000 CHF

Mainly due to increasing maintenance fees and translation costs

Often patent applications are filed via PCT

Advantages?

Cost efficient until final decision on importance

Early comments on patentability before occurence of major costs

London Agreement: Entry into Force on May 1, 2008 (many aspects still unclear; will lead to a considerable reduction of filing costs

18© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Trademark Law – Extension of Monopoly

19© Dr. iur. Martin Schneider Ahmedabad, India - 09/10 February 2008

Swiss Patent Law history Parallels to India Patent Law development?