[Ip-health] Pfizer threats another Philippine generic company with litigation to stop legal competition

[Judit Rius Sanjuan]

Blog post with links to relevant documents available here:
http://secondview.blogspot.com/2006/12/pfizer-threats-another-philippine.ht=
ml


Pfizer threats another Philippine generic company with litigation to
stop legal competition
By Judit Rius Sanjuan

Pfizer is striking the Philippines generic industry again. Orient Euro
Pharma (OEP) Philippines, a subsidiary of OEP Taiwan recently launched a
generic version of olmesartan medoxomil a product for the treatment of
hypertension developed by Sankyo but marketed by Pfizer in the Philippines.

There is currently no patent for Olmesartan Medoxomil in the Philippines
(Sankyo does have a patent application pending that OEP argues does not
cover Olmesartan Medoxomil, but Olmesartan Medoxomil in combination with
Hydrochlorothiazide).

However, this has not stopped Pfizer from threatening OEP and the
manufacturer of the product (Hizon Laboratories, Inc.) with legal
actions to prevent commercialization of the generic products that have
considerably lowered the prices of Olmesartan Medoxomil in the Philippines.

Pfizer prices (under brandname Olmetec):
10mg strength PHP 38.94 per tablet
20mg strength PHP 47.20 per tablet
40mg strength PHP 70.72 per tablet

OEP Prices (under brandname Olmezar):
20mg strength PHP 18.53 per tablet
40mg strength PHP 24.75 per tablet
Note: 1 USD =3D 49.5 PHP, all prices are ex-retail prices inclusive of 12%
VAT.

Pfizer seems to be claiming that:
1. They have 5 years of data exclusivity since Olmetec was launched in
the Philippines (January 2005) under article 39.3 of the TRIPS Agreement
and the Intellectual Property Code of the Philippines (Republic Act No.
8293).
2. OEP relied on Pfizer=92s undisclosed test data to register its generic
version.

OEP filed for a DECLARATORY RELIEF on November 2006 with the Philippine
courts and the following are their main arguments, along with my analysis:

a) Article 39.3 of the TRIPS Agreement is not a self-executing provision
upon which Pfizer could sue OEP and Hizon.

This is correct. Article 39.3 of the TRIPS Agreement only mandates a
minimal standard of protection that WTO Member=92s have to implement.
There exists a need for a legislative enactment on Article 39.3 to give
it effect in the Philippines.

b) When implementing its obligations under Article 39.3 of the TRIPS
Agreements, the Philippines do not have to grant =93data/marketing
exclusivity=94 over pharmaceutical test data.

This is also correct. Article 39.3 only requires WTO Members States to
protect from unfair commercial use and sometimes disclosure the
pharmaceutical undisclosed test data that originated from new chemical
entities, which required considerable effort to generate, and which is
required to be submitted to national regulatory authorities to obtain
marketing approval.

When implementing its TRIPS obligations WTO=92s members have broad
discretion and as Article 1.1 of the TRIPS Agreement provides =93members
shall not be obliged to, implement in their law more extensive
protection than is required by this Agreement=85 Members shall be free to
determine the appropriate method of implementing the provisions of this
Agreement within their own legal system and practice.=93

On 8 September 2006 (Annex =93I=94 here and here), Pfizer=92s counsel, Sigu=
ion
Reyna Montecillo and Ongsiako, wrote TO OEP=92s counsel answering a
previous communication (Annex =93H=94 here and here). It stated as follows:
=93=85Your interpretation of TRIPS 39.3 =96 that it does not relate to data=
 or
market exclusivity =96 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=85 =93

Pfizer is wrong here. Article 39.3 of the TRIPS Agreement does not
mandate a data or market exclusivity regime. In fact, only a few
countries, the U.S. and the E.U. where brand-name/ originators
pharmaceutical companies have an important presence, have traditionally
implement its Article 39.3 obligations granting a period of exclusivity
to the originator of test data.

It is not only academics, civil society and generics companies that
defend this interpretation of the TRIPS Agreement. The WHO=92s Commission
on Intellectual Property Rights, Innovation and Public Health (CIPIH)
2006 Report is also clear:
=93Article 39.3, unlike the case of patents, does not require the
provision of specific forms of rights. But it does oblige Members to
protect undisclosed test or other data against unfair commercial use. It
does not create property rights, nor a right to prevent others from
relying on the data for the marketing approval of the same product by a
third party, or from using the data except where unfair (dishonest)
commercial practices are involved.
Thus, the TRIPS agreement does not refer to any period of data
protection, nor does it refer to data exclusivity. In some countries,
however, such as the United States, a sui generis regime was adopted
prior to the TRIPS agreement under which, for a period of five years
from marketing approval, no other company may seek regulatory approval
of an equivalent product based on that data without the approval of the
originator company...... If the patent period has expired, or there is
no patent on the product, this sui generis data exclusivity may act
independently of patent status to delay the entry of any generic
companies wishing to enter the market. This is because the regulators
cannot use the data in the period of protection to approve a product,
even if the product is demonstrated to be bio-equivalent, where
required. The only alternative for a generic company would be to repeat
clinical trials, which would be costly and wasteful, and would raise
ethical issues since it would involve replicating tests in humans to
demonstrate what is already known to be effective. These sui generis
regimes, which provide for data exclusivity need to be clearly
differentiated from the TRIPS agreement's requirement for data protection.=
=94

To learn more about pharmaceutical data exclusivity visit CPTech website
on the topic.

c) OEP also claims that at present, Article 39.3 of the TRIPS Agreement
does not have a mirror or counterpart provision under any Philippine law
or statute.

As explained, WTO members have to implement the TRIPS Agreement with
national regulations to give it effect. My understanding is that the
Philippine has implemented its article 39.3 TRIPS obligations with a
test data protection regime that does not provide any marketing or data
exclusivity, but that provides protection to marketing approval data
against unfair commercial use under certain conditions.

As the Government of the Philippines reported during 2005 WTO Trade
Policy Review, the implementation has been done mainly though the Food,
Drug and Cosmetic Act (Republic Act No. 3720) and general business
confidentiality regulations.

As one Philippine lawyer reported to me, Test Data Protection is
enforced in the Philippines through BFAD issuances requiring strict
confidentiality of drug applications to prevent unauthorized disclosure
and "unfair commercial use".

The relevant laws and regulations are:
=93a) Republic Act No. 3720, as amended: Prohibits the using by any person
to his own advantage, or revealing, other than to the Secretary or
officers and employees of the Department or to the courts when relevant
in any judicial proceeding under the Act, any information concerning any
method or process which as a trade secret is entitled to protection.
b) BFAD Order No. 27-A s. 2001 (Confidentiality of Documents): This
directs BFAD employees to observe strictly the confidentiality of
documents submitted for evaluation and/or registration.
c) Revised Penal Code, as amended: which penalizes the revelation of
secrets by a public officer known to him by reason of his official
capacity as well as revelation of industrial secret by private person.
d) Republic Act No. 6713 (Code of Conduct and Ethical Standards for
Public Officials and Employees): This prohibits the disclosure and/or
misuse of confidential information to further their private interest or
to the prejudice of the public interest.
Significantly, Republic Act No. 8293 otherwise known as the Intellectual
Property Code of the Philippines includes "protection of undisclosed
information" as one of the intellectual property rights=94.
(Source: 2005 WTO Trade Policy Review, WT/TPR/M/149/Add.1)

d) Finally, OEP claims that in obtaining registration for the product
they did not have access to any undisclosed test data submitted and they
only used information publicly available as well as test data that they
generated themselves.

For instance, OEP argues that the website of the Center for Drug
Evaluation Research and the U.S. Food and Drug Administration contains a
wealth of information on olmesartan medoxomil, and that a comprehensive
paper entitled =93Olmesartan Medoxomil, a Novel Potent Angiotensin II
blocker=94 is downloadable from the internet.


In conclusion, there is no regime of test data/marketing exclusivity in
the Philippines. The obligation of Article 39.3 of the TRIPS agreement
was implemented into the Philippines with a pure test data protection
regime that is in compliance with the TRIPS Agreement. Therefore Pfizer
claims that they have 5 years of data exclusivity since Olmetec was
launched in the Philippines is a misinterpretation of the current legal
regime as mandated by the TRIPS Agreement and implemented in the
Philippines and in most of the countries of the world.

In 2001 the Philippines government (with other developing countries) was
already publically interpreting their legal regime as not providing data
exclusivity.

Now, the Philippine=92s courts should protect the Philippine=92s government=
s
efforts to provide access to more affordable medicines and to support a
national industry of generic manufacturers and should issue a clear
judgment establishing that:
- Article 39.3 of the TRIPS Agreement is not a self-executing provision
upon which Pfizer could sue under Philippine=92s law.
- When implementing its obligations under Article 39.3 of the TRIPS
Agreements, the Philippines law does not have to grant =93data/marketing
exclusivity=94 over pharmaceutical test data and its implementation with a
pure test data protection regime is TRIPS compliant.
- If, as OEP claims, in obtaining registration for their products they
only used information publicly available as well as test data that they
generated themselves, OEP did not violate any of Pfizer=92s trade secrets.

--
Judit Rius Sanjuan
judit.rius at cptech.org
www.cptech.org

Consumer Project on Technology
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