Linking Intellectual Property Rights to Drug

Registration: Practices and Experiences Jose Maria A. Ochave, Esq.

Philippine Judicial Academy

Seminar on Data Exclusivity and Patent Linkage in FTA: Int erpretation and Implications to Public Health 25, August

2006, , Rama Garden H otel, Bangkok

Presentation Outline

IPRs relevant to the Pharmaceutical Sector

The Philippine Experience as a case Stud y in Anti Competitive Use of IPRs

The Response of the Phillipine Bureau of Foods and Drugs

Thai experiences requesting for patent linkage

Concluding Remarks

IPRs Relevant to the Pha rmaceutical Sector

Patents product patent (e.g., molecular, formulation, salt, enantiome

r) process (e.g., synthesis, purification) Second use/new use, method of use

Trademarks Copyright Undisclosed Information

The Philippine Experience as Case

Study 72Market is % controlled by MNCs RRRRRRRRRRR RR RRRRRRRRRR RR RRRR RRRRR RRRRR RRRRRRR RRRRRRRRR RRRRRRRR RRRR

R RRRRR RRR5 RR RRRRRRR RRRR RR RRRRRRR RRRRRR. IPRS have been used by some MNCs as tool to prevent competition RRRRRRRRRR RRRRRRRR RR RRRRRRR RRRRRRRRR RR RRRRRR RRRRRRRRRRRR

- anal ysi s and sour i ng of non i nf r i ngi ng pr oduct s IP Code does not even contain TRIPS flexibilities

The Philippine Experience as Case

Study Typical roadblocks against generic companies competition: Threats of patent infringement suit Interventions to prevent or delay product registration by alleg

ing safety issue and “data exclusivity” Marketing campaign to create doubts about safety of generic

products and indirectly link them to fake medicines

Dragging BFAD into Debate

The attempt to drag the Philippine drug reg ulatory authorities into IPR issues

Cefaclor case Parallel importation by Philippine International T

rading Corporation Felodipine case Sidenafil dispute Amlodipine besylate incident

BFAD response

DOH Administrative order No. 2005-0001, on Patent and trade secrets

DOH Administrative Order No. 2005-0016, on Brand Name

Thai Experiences: Case I Patent relevant: New Finasteride Process Warning request from a law firm indicatin

g that it is possible that the Thai FDA may approv

e certain generic formulations incorrectly as the generic products are protected by a

patent claimed With respect to the FDA, it is recommend t

hat the FDA withdraw the approved generi c formulations

Thai Experiences: Case II Patent relevant: ezetimbe submitted information for registration of ezeti

mbe and fenofibrate combination therapy Action request

the FDA shall not approve any generic formulation s containing ezetimbe as it is protected by a patent

the FDA shall not approve a third party marketing authorization for generic formulations containing e

ztimbe and fenofibrate combined therapy based on the information submitted by the original company

before

Concluding Remarks. IPRs must be protected, but abuses of the

system should be curtailed There is a huge economic incentive to pre

vent generic competition. Hence, the atte mpt to link IPRS and drug registration

Drug regulatory authorities (DRA) are no t in any position to protect IPRS on behalf

of their owners. The principal mandate is safety, efficacy, and quality.

Concluding Remarks Transparency in drug registration process, whi

le desirable, could be abused to prevent or dela y generic competition.

There are institutions outside the DRAs that ca n better address IPRs concerns

In the Thai registration system, even no curren t legislation is allowed for patent linkage, reque

sts from a law firm for providing its clients a pa tent linkage happened

Both the industry and FDA must be well aware and should not be cheated by the law firm

Acknowledgment

Mr. Jose M. Ochavem Esq. and colleagu es for allowing to use the his slide prese

ntation on patent linkage

Thank you