REPUBLIC OF THE PHILIPPINES

NATIONAL CAPITAL JUDICIAL REGION

REGIONAL TRIAL COURT
MAKATI CITY, BRANCH ____

OEP PHILIPPINES, INC. CIVIL CASE NO. _____

Petitioner,

- versus -
For: Declaratory Relief
(Article 39.3, Agreement on
Trade-Related Aspects of
Intellectual Property Rights,
otherwise known as “TRIPS”)

PFIZER, INC.
Defendant.
x-----------------------------------------------x

PETITION

Petitioner, OEP PHILIPPINES, INC., by counsel, respectfully states:

Parties

1. Petitioner OEP Philippines, Inc. (“OEP”), is a Philippine

corporation engaged in the marketing and distribution of pharmaceutical

products. Its office address is at 6th Floor SEDCCO Building, Rada corner

Legaspi Streets, Legaspi Village, Makati City. Petitioner is represented in

this action by its counsel, Bengzon Negre Untalan Intellectual Property

Attorneys, with principal address at 2nd Floor SEDCCO Building, Rada

corner Legaspi Streets, Legaspi Village, Makati City, where it may be

served with summons and other processes.

 2. Respondent Pfizer, Inc. (“Pfizer”), is a Philippine corporation

likewise engaged in the manufacture and distribution of pharmaceutical

products. Its principal address is at 23/F Ayala Life-FGU Center, 6811

Ayala Avenue, Makati City.

Antecedents

3. Petitioner OEP is a reputable manufacturer and distributor of

pharmaceutical products. On 8 December 2003, OEP requested the

Intellectual Property Office (“IPO”) to conduct a comprehensive patent

search on “Olmesartan Medoxomil.” The comprehensive patent search

yielded negative results. Accordingly, OEP commenced development of a

pharmaceutical composition containing “Olmesartan Medoxomil.”

4. On 5 February 2004, OEP submitted an application for ACB

clearance for “Olmesartan Medoxomil” with the Bureau of Food and

Drugs (“BFAD”). This submission consisted of documents retrieved from

the public domain (copies of these documents are compiled in the attached

blue binders 1 and 2, which form as integral parts of this Petition). The

documents demonstrate the safety and efficacy of “Olmesartan

Medoxomil.” On 14 December 2005, following ACB clearance, OEP

submitted its application for initial registration of its product containing

“Olmesartan Medoxomil.” This submission consisted entirely of test data

generated by OEP itself. On 23 May 2006 and 31 October 2006, BFAD

issued the corresponding certificates of product registration (“CPR”) for

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Olmezar 20mg and 40mg, respectively. Copies of the said CPRs are

attached as Annexes “A” and “A-1.”

5. As a gesture of good faith, and prior to its intended launch, in

a letter dated 11 August 2005 (Annex “B”), OEP’s General Manager, Mr.

Sam Gioskos, inquired from defendant Pfizer whether it has an existing

Philippine patent covering the compound “Olmesartan Medoxomil.” In its

letter of 13 September 2005 (Annex “C”), Pfizer informed OEP that

Philippine Patent Application No. 1-2003-500400, which is directed to

“Olmesartan Medoxomil + Hydrochlorothiazide,” was filed on 19

November 2001 under the name of Sankyo Company Limited (“Sankyo”).

According to Pfizer, Sankyo licensed Pfizer to use the compound.

6. In a letter to Pfizer dated 28 October 2005 (Annex “D”), OEP’s

Mr. Gioskos told Pfizer that its “principal or affiliate did not submit any

patent application that corresponds to or is equivalent to European Patent

0503785” which covers the compound “Olmesartan Medoxomil.” OEP also

stated that Philippine Patent Application No. 1-2003-500400, which

pertains to “Olmesartan Medoxomil + Hydrochlorothiazide,” is not an

impediment to the launch of OEP’s composition containing only

“Olmesartan Medoxomil.”

7. On 5 June 2006 (Annex “E”), OEP wrote Sankyo, the

developer of “Olmesartan Medoxomil” and Pfizer’s principal, to inquire if

Sankyo has patents or pending patent applications that cover “Olmesartan

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Medoxomil.” OEP did not receive any reply, written or otherwise, from

Sankyo. Hence, OEP took it to mean that Sankyo has no patents or

pending patent applications for “Olmesartan Medoxomil.”

8. In view of the absence of any patent or pending patent

application covering “Olmesartan Medoxomil,” OEP decided to proceed

with the launch of its version of the same compound. OEP contracted

Hizon Laboratories, Inc. (“Hizon”) to manufacture its “Olmesartan

Medoxomil” product. A copy of the agreement between OEP and Hizon is

attached as Annex “F.”

9. However, on 10 August 2006 (Annex “G”), Hizon informed

OEP that the Legal Department of Pfizer wrote Hizon by e-mail regarding

“Olmesartan Medoxomil.” Per Hizon’s letter, Pfizer claimed that it

“currently has market exclusivity for Olmesartan” pursuant to the

Agreement on Trade-Related Aspects of Intellectual Property Rights

(“TRIPS Agreement”) and the Intellectual Property Code of the Philippines

(Republic Act No. 8293 or “IP Code”). Pfizer also claimed that “it has data

exclusivity for at least five (5) years from launch and that OEP used the

same data to register Olmezar,” which Pfizer claims is in violation of the

TRIPS Agreement and the IP Code.

10. On 14 August 2006 (Annex “H”), OEP, through counsel, wrote

Pfizer explaining that: (a) Article 39.3 of the TRIPS Agreement refers only

to protection of undisclosed data that is confidential in nature; and (b) OEP

did not use undisclosed data; instead, it used information that was

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publicly available. OEP further explained that “Article 39.3 of the TRIPS

Agreement is not data exclusivity but a form of data protection which is

intended to prevent unfair commercial use of data by third parties.”

“Exclusivity” and “protection from acts of unfair competition” are not the

same.

11. On 8 September 2006 (Annex “I”), Pfizer’s counsel, Siguion

Reyna Montecillo and Ongsiako, wrote OEP’s counsel on the matter. It

stated as follows:

We disagree with your argument that Article

39.3 of the TRIPS Agreement is inapplicable to
product registration data lodged with the Bureau of
Food and Drugs (BFAD). TRIPS 39.3 clearly requires
member countries to protect undisclosed registration
data against unfair commercial use and disclosure.
The provision also clearly relates to the
pharmaceutical product registration process and its
protection was obviously intended to cover
pharmaceutical data submitted in the course of such a
process.

Your interpretation of TRIPS 39.3 – that it does

not relate to data or market exclusivity – is a version
promoted by interested sectors of the pharmaceutical
industry seeking to influence contemporary
interpretations of the provision, to their benefit. The
literature on the matter does not bear out this
interpretation, however. State parties respecting the
TRIPS 39.3 protections recognize that a period of data
protection is needed, providing innovator companies
with incentive to make the necessary investment in
pharmaceutical test and trial data.

12. In the same letter, Pfizer stated that it “reserves its right to

proceed against any party, including OEP if necessary, to protect its

proprietary data against unauthorized or unfair use.” This statement is

clearly a threat from Pfizer that it will sue OEP in the immediate future.

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 13. OEP, through its counsel’s letter of 20 September 2006 to

Pfizer, reiterated that:

Article 39.3 of the TRIPS Agreement is not data

exclusivity but a form of data protection which is
intended to prevent unfair commercial use of data by
third parties.

xxx xxx xxx

Article 39.3 of the TRIPS Agreement clearly

states that the subject of protection must consist of
“undisclosed test or other data.” Data that is available
in the public domain is not covered by this provision.

14. Recently, OEP received information that Pfizer is spreading

news that it is suing Hizon for manufacturing olmesartan medoxomil. The

news is circulating like wildfire in the pharmaceutical industry. Hence,

OEP is left with no recourse but to seek for declaratory relief.

Discussion

15. The subject matter of this instant Petition is Article 39.3 of the

TRIPS Agreement, which states, to wit:

Members, when requiring, as a condition of

approving the marketing of pharmaceutical or of
agricultural chemical products shall utilize new
chemical entities, the submission of undisclosed tests
or other data, the origination of which involves a
considerable effort, shall protect such data against
unfair commercial use. In addition, Members shall
protect such data against disclosure, except where
necessary to protect the public, or unless steps are

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 taken to ensure that the data are protected against
unfair commercial use.

16. For a wider perspective on the meaning and scope of Article

39.3, it should be read within the context of the entire Article 39 of the

TRIPS Agreement, which reads:

Protection of Undisclosed Information

Article 39

1. In the course of ensuring effective protection

against unfair competition as provided in Article
10bis of the Paris Convention (1967), Members shall
protect undisclosed information in accordance with
paragraph 2 and data submitted to governments or
governmental agencies in accordance with paragraph
3 (Article 39.1)

2. Natural and legal persons shall have the

possibility of preventing information lawfully within
their control from being disclosed to, acquired by, or
used by others without their consent in a manner
contrary to honest commercial practices so long as
such information:

(a) is secret in the sense that it is not, as a body

or in the precise configuration and assembly of its
components, generally known among or readily
accessible to persons within the circles that normally
deal with the kind of information in question;

(b) has commercial value because it is secret;

and

(c) has been subject to reasonable steps under

the circumstances, by the person lawfully in control of
the information, to keep it secret.

3. Members, when requiring, as a condition of

approving the marketing of pharmaceutical or of
agricultural chemical products shall utilize new
chemical entities, the submission of undisclosed tests
or other data, the origination of which involves a
considerable effort, shall protect such data against
unfair commercial use. In addition, Members shall
protect such data against disclosure, except where
necessary to protect the public, or unless steps are

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 taken to ensure that the data are protected against
unfair commercial use.

17. The TRIPS Agreement is an international treaty administered

by the World Trade Organization (WTO) which sets down minimum

standards for most forms of intellectual property (IP) regulation within all

member countries of the WTO. It was negotiated at the end of the Uruguay

Round of the General Agreement on Tariffs and Trade (GATT) treaty in

1994. When the Philippines became a member of the WTO, it had

automatically acceded to the TRIPS Agreement. The obligations under

TRIPS apply equally to all member states.

18. Article 39.3 of the TRIPS Agreement is not a self-executing

provision. Instead, the article merely sets broad parameters upon which

WTO member-states should impose a regime of protection for

“undisclosed information” submitted to the government for marketing

approval. This is emphasized in Article 1.1 of the TRIPS Agreement which

provides, to wit:

Members shall give effect to the provisions of

this Agreement. Members may, but shall not be
obliged to, implement in their law more extensive
protection than is required by this Agreement,
provided that such protection does not contravene the
provisions of this Agreement. Members shall be free
to determine the appropriate method of
implementing the provisions of this Agreement
within their own legal system and practice.

There is therefore a need for a legislative enactment on Article 39.3

to give it effect in the Philippines.

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 19. At present, Article 39.3 of the TRIPS Agreement does not have

a mirror or counterpart provision under any Philippine law or statute. In

any event, the Philippines, together with a number of countries, has

already publicly rejected the interpretation that Article 39.3 of the TRIPS

Agreement requires granting of “exclusive rights” or “data exclusivity” to

the owner of the data (“Protection of Data for the Registration of

Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, Carlos

Maria Correa, University, p.52 [footnote # 35]). Some countries, nevertheless,

have gone beyond what is mandated by Article 39 (particularly Article

39.3) of the TRIPS Agreement as they enacted national laws providing for

“data exclusivity” over a specified period of time

(http://www.expresspharmaonline.com/20021121/oped.shtml). These countries,

however, have granted such “data exclusivity” as a consequence of

bilateral or regional free trade negotiations, bilateral investment

agreements and/or other international agreements and treaties (Briefing

Note on Access to Medicines, World Health Organization, Western Pacific

Region, pp. 2-3 on the sub-topic: “TRIPS Does Not Require Data Exclusivity).

20. Inasmuch as Pfizer insists that it acquires rights from Article

39.3 of the TRIPS Agreement, and OEP believes that it does not, there is a

need for this Honorable Court to declare that Pfizer cannot sue OEP or

Hizon on the basis of Article 39.3 of the TRIPS Agreement.

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 21. Assuming, without conceding, that Article 39.3 is self-

executory, OEP submits that it does not provide for “data exclusivity” but

is more concerned with assuring that “undisclosed data is protected from

unfair commercial use.”

22. As may be culled from the exchanges between petitioner OEP

and Pfizer, there is clear disagreement on the scope Article 39.3 of the

TRIPS Agreement. Pfizer considers Article 39.3 as catering to “data

exclusivity” over a certain period. On the other hand, OEP believes that

Article 39.3 simply suggests a form of data protection which is intended to

prevent unfair commercial use of data by third parties. While Pfizer

maintains that it has “market exclusivity” for “Olmesartan Medoxomil”

pursuant to Article 39.3 of the TRIPS Agreement, OEP thinks that the same

provision does not give Pfizer exclusivity over any publicly available data

submitted to the BFAD. At most, Pfizer’s rights under Article 39.3 are

limited to protection of undisclosed data, or data that is not publicly

available, from unfair commercial use. OEP did not use undisclosed or

confidential data; much so, it did not resort to any form of unfair

competition.

23. In order to determine the rights of the parties under Article

39.3 of the TRIPS Agreement, there is a pressing need to construe its scope

and meaning. Particularly, OEP submits that this Honorable Court should

declare that Article 39.3 of the TRIPS Agreement does not grant “data

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exclusivity” or “market exclusivity” over test data submitted to the

BFAD for marketing approval.

24. The TRIPS Agreement, under Article 39.3, establishes a

minimum standard for the protection of undisclosed data submitted for

marketing approval. This does not mean, however, that such protection

requires the grant of exclusive rights to the originator of the data. The

value of undisclosed information is not premised on inventive step or

novelty; but, it is premised on the fact that undisclosed information has

commercial value and on its “confidentiality.” Unlike patents, protection

of undisclosed information under Article 39.3 does not amount to a

conferment of property rights.

25. The Vienna Convention on the Law of the Treaties, to which

the Philippines is a party, provides guidance on how to properly interpret

Article 39.3 of the TRIPS Agreement. It instructs that the ordinary meaning

and context of the terms used, and the object and purpose of the treaty

must be carefully considered. Also, it states that the history of the

negotiation is also an important complementary element for interpretation

(Article 31 (2), Vienna Convention).

26. The wording, context and purpose of Article 39.3 does not

support an interpretation that the required protection refers to

“exclusivity” protection. First, there is no categorical mention of “data

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exclusivity” in the subject article. Second, a cursory reading of Article

39.3’s provision reveals the following:

(a) It requires governments to provide protection to marketing

approval data only under certain conditions.

(b) Test data must be protected if national authorities require its

submission.

(c) It does not require that protection be given to public data

submitted for marketing approval. To qualify for protection under Aticle

39.3, the pertinent information must be “undisclosed.” This means that

information that is already within the public domain does not fall within

the scope of the article.

(d) Protection is required only for new chemical entities. Article

39.3 would not apply in cases where approval is sought for new

indications, dosage forms, combinations, new forms of administration,

crystalline forms, isomers, etc. of existing drugs, since there would be no

novel chemical entity involved.

(e) Article 39.3 requires countries to protect against “unfair

commercial use” of marketing approval data. Instances of “unfair

commercial use” are: (a) a competitor obtains the results of testing data

through fraud, breach of confidence or other dishonest practices and uses

them to submit an application for marketing approval for its own benefit;

(b) the government provides access to undisclosed testing data in order to

provide an advantage to a firm which did not produce them or share their

cost. Protection from “unfair commercial use” is not “data exclusivity.”

Data exclusivity creates a form of property right; it presupposes

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unconditional protection of test data over a period of time. In data

exclusivity, data remains exclusive in favor of its originator regardless of

the nature and manner of use, or whether there is “unfair commercial use”

or not.

27. Further, the negotiating history of Article 39.3 reveals that the

parties considered at length, but did not adopt, text which required

exclusivity for test data. European, Japanese and United States business

communities advocated for the establishment of a data exclusivity regime.

This was also the submission of the United States representative to the

TRIPS Agreement negotiations. Nonetheless, these concepts were rejected

(See “Protection of Data Submitted for the Registration of Pharmaceuticals:

Implementing the Standards of the TRIPS Agreement,” Carlos Maria Correa,

University of Buenos Aires).

28. OEP maintains that it did not violate any of Pfizer’s rights

under Article 39.3 of the TRIPS Agreement. However, in view of Pfizer’s

position that OEP did so, OEP invites this Honorable Court to also rule

that, under the given factual circumstances, OEP did not violate any of

Pfizer’s rights, if any, under Article 39.3 of the TRIPS Agreement.

29. OEP generated its own test data for its olmesartan medoxomil

product. It also used data that is available in the public domain. There was

sufficient data on olmesartan medoxomil that is publicly available. For

instance, the website of the Center for Drug Evaluation Research and the

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U.S. Food and Drug Administration contains a wealth of information on

olmesartan medoxomil (http://www.fda.gov/cder/foi/nda/2002/21-

286_Benicar.htm). A comprehensive paper entitled “Olmesartan

Medoxomil, a Novel Potent Angiotensin II blocker” is downloadable from

the internet.

RELIEF

WHEREFORE, petitioner OEP Philippines, Inc. respectfully prays

that this Honorable Court, by way of declaratory relief, issue a Decision

ruling that:

(a) Article 39.3 of the TRIPS Agreement is not a self-

executing provision upon which Pfizer could sue OEP and Hizon;

(b) Article 39.3 of the TRIPS Agreement does not mandate

the grant of “data exclusivity” or “market exclusivity” over test data

submitted to the BFAD for marketing approval; and

(c) OEP did not violate any of Pfizer’s rights under Article

39.3 of the TRIPS Agreement.

Other relief, just or equitable under the premises, are likewise

prayed for.

Makati City, 20 November 2006.

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 BENGZON NEGRE UNTALAN
Intellectual Property Attorneys
Counsel for Petitioner
nd
2 Floor, SEDCCO Building
Rada corner Legaspi Streets
Legaspi Village, Makati City

By:

Ferdinand M. Negre
Roll of Attorneys No. 37923
PTR: 4182680E- 01/03/06- Makati City
IBP: LRN 04281 – 1/08/03- RSM

Jonathan Q. Perez
Roll of Attorneys No. 46088
PTR: 4182686E-01/03/06-Makati City
IBP: 665590-1/04/06 - Tarlac

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 VERIFICATION / CERTIFICATION

I, SAM GIOSKOS, of legal age, under oath, depose and state:

1. I am the General Manager of petitioner OEP Philippines, Inc.

(“OEP”), with express authority to sign this Verification and Certification.
Attached as Annex “A” is a copy of the Secretary’s Certificate dated 20
November 2006.

2. I caused the preparation of the foregoing petition.

3. I have read the contents of the said petition and the

allegations therein are true and correct of my own personal knowledge
and based on authentic documents.

4. OEP has not commenced any other action or proceeding or

filed claims involving the same issues and subject matter before any
tribunal or quasi-judicial agency and to the best of my knowledge, no such
action or claim is pending therein; if I should thereafter learn that a same
or similar action or claim has been filed or is pending, I shall report that
fact to this office within five (5) days therefrom.

IN WITNESS WHEREOF, I have hereunto affixed my signature this

th
20 day of November 2006 at Makati City.

Sam Gioskos
Affiant

SUBSCRIBED AND SWORN to before me this 20 th day of November

2006 in Makati City, affiant exhibited to me his Driver’s License No. 011-
X01-96-031653, expiring on May 11, 2008.

Notary Public
Doc. No. ____;
Page No. ____;
Book No. ____;
Series of 2006.

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