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Cases On Ra8203

This document summarizes a Supreme Court case regarding the constitutionality of provisions in the Special Law on Counterfeit Drugs (SLCD) that classified imported drugs as counterfeit if they were not purchased from the authorized Philippine distributor. The Court did not rule on the constitutional issues because a new law, the Universally Accessible Cheaper and Quality Medicines Act of 2008, was passed that amended intellectual property laws to explicitly allow third parties to import patented drugs as long as they have been introduced in the Philippines or elsewhere by the patent owner.
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0% found this document useful (0 votes)
140 views

Cases On Ra8203

This document summarizes a Supreme Court case regarding the constitutionality of provisions in the Special Law on Counterfeit Drugs (SLCD) that classified imported drugs as counterfeit if they were not purchased from the authorized Philippine distributor. The Court did not rule on the constitutional issues because a new law, the Universally Accessible Cheaper and Quality Medicines Act of 2008, was passed that amended intellectual property laws to explicitly allow third parties to import patented drugs as long as they have been introduced in the Philippines or elsewhere by the patent owner.
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Download as DOCX, PDF, TXT or read online on Scribd
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SECOND DIVISION

ROMA DRUG and ROMEO G.R. No. 149907


RODRIGUEZ, as Proprietor
of ROMA DRUG, Present:
Petitioners,
QUISUMBING, J.,
Chairperson,
CARPIO-MORALES,
TINGA,
- versus - VELASCO, and
BRION, JJ.

Promulgated:

THE REGIONAL TRIAL COURT

OF GUAGUA, PAMPANGA, THE

PROVINCIAL PROSECUTOR OF April 16, 2009

PAMPANGA, BUREAU OF FOOD

& DRUGS (BFAD) and GLAXO

SMITHKLINE,

Respondents.

x----------------------------------------------------------------------------x

DECISION

TINGA, J.:

On 14 August 2000, a team composed of the National Bureau of Investigation (NBI) operatives and
inspectors of the Bureau of Food and Drugs (BFAD) conducted a raid on petitioner Roma Drug, a duly
registered sole proprietorship of petitioner Romeo Rodriguez (Rodriguez) operating a drug store located at San
Matias, Guagua, Pampanga. The raid was conducted pursuant to a search warrant1 issued by the Regional Trial
Court (RTC), Branch 57, Angeles City. The raiding team seized several imported medicines, including
Augmentin (375mg.) tablets, Orbenin (500mg.) capsules, Amoxil (250mg.) capsules and Ampiclox (500mg.).2 It
appears that Roma Drug is one of six drug stores which were raided on or around the same time upon the
request of SmithKline Beecham Research Limited (SmithKline), a duly registered corporation which is the local
distributor of pharmaceutical products manufactured by its parent London-based corporation. The local
SmithKline has since merged with Glaxo Wellcome Phil. Inc to form Glaxo SmithKline, private respondent in
this case. The seized medicines, which were manufactured by SmithKline, were imported directly from abroad
and not purchased through the local SmithKline, the authorized Philippine distributor of these products.

The NBI subsequently filed a complaint against Rodriguez for violation of Section 4 (in relation to
Sections 3 and 5) of Republic Act No. 8203, also known as the Special Law on Counterfeit Drugs (SLCD), with
the Office of the Provincial Prosecutor in San Fernando, Pampanga. The section prohibits the sale of counterfeit
drugs, which under Section 3(b)(3), includes an unregistered imported drug product. The term unregistered
signifies the lack of registration with the Bureau of Patent, Trademark and Technology Transfer of a trademark,
tradename or other identification mark of a drug in the name of a natural or juridical person, the process of
which is governed under Part III of the Intellectual Property Code.

In this case, there is no doubt that the subject seized drugs are identical in content with their Philippine-
registered counterparts. There is no claim that they were adulterated in any way or mislabeled at least. Their
classification as counterfeit is based solely on the fact that they were imported from abroad and not purchased
from the Philippine-registered owner of the patent or trademark of the drugs.

During preliminary investigation, Rodriguez challenged the constitutionality of the SLCD. However,
Assistant Provincial Prosecutor Celerina C. Pineda skirted the challenge and issued a Resolution dated 17
August 2001 recommending that Rodriguez be charged with violation of Section 4(a) of the SLCD. The
recommendation was approved by Provincial Prosecutor Jesus Y. Manarang approved the recommendation.3

Hence, the present Petition for Prohibition questing the RTC-Guagua Pampanga and the Provincial
Prosecutor to desist from further prosecuting Rodriguez, and that Sections 3(b)(3), 4 and 5 of the SLCD be
declared unconstitutional. In gist, Rodriguez asserts that the challenged provisions contravene three provisions
of the Constitution. The first is the equal protection clause of the Bill of Rights. The two other provisions are
Section 11, Article XIII, which mandates that the State make essential goods, health and other social services
available to all the people at affordable cost; and Section 15, Article II, which states that it is the policy of the
State to protect and promote the right to health of the people and instill health consciousness among them.

Through its Resolution dated 15 October 2001, the Court issued a temporary restraining order enjoining
the RTC from proceeding with the trial against Rodriguez, and the BFAD, the NBI and Glaxo Smithkline from
prosecuting the petitioners.4

Glaxo Smithkline and the Office of the Solicitor General (OSG) have opposed the petition, the latter in
behalf of public respondents RTC, Provincial Prosecutor and Bureau of Food and Drugs (BFAD). On the
constitutional issue, Glaxo Smithkline asserts the rule that the SLCD is presumed constitutional, arguing that
both Section 15, Article II and Section 11, Article XIII are not self-executing provisions, the disregard of which
can give rise to a cause of action in the courts. It adds that Section 11, Article XIII in particular cannot be work
to the oppression and unlawful of the property rights of the legitimate manufacturers, importers or distributors,
who take pains in having imported drug products registered before the BFAD. Glaxo Smithkline further claims
that the SLCD does not in fact conflict with the aforementioned constitutional provisions and in fact are in
accord with constitutional precepts in favor of the peoples right to health.

The Office of the Solicitor General casts the question as one of policy wisdom of the law that is, beyond
the interference of the judiciary.5 Again, the presumption of constitutionality of statutes is invoked, and the
assertion is made that there is no clear and unequivocal breach of the Constitution presented by the SLCD.

II.

The constitutional aspect of this petition raises obviously interesting questions. However, such questions
have in fact been mooted with the passage in 2008 of Republic Act No. 9502, also known as the Universally
Accessible Cheaper and Quality Medicines Act of 2008.6

Section 7 of Rep. Act No. 9502 amends Section 72 of the Intellectual Property Code in that the later law
unequivocally grants third persons the right to import drugs or medicines whose patent were registered in the
Philippines by the owner of the product:

Sec. 7. Section 72 of Republic Act No. 8293, otherwise known as the Intellectual
Property Code of the Philippines, is hereby amended to read as follows:

Sec. 72. Limitations of Patent Rights. The owner of a patent has no right to prevent third
parties from performing, without his authorization, the acts referred to in Section 71 hereof in the
following circumstances:

72.1. Using a patented product which has been put on the market in the Philippines by the
owner of the product, or with his express consent, insofar as such use is performed after that
product has been so put on the said market: Provided, That, with regard to drugs and
medicines, the limitation on patent rights shall apply after a drug or medicine has been
introduced in the Philippines or anywhere else in the world by the patent owner, or by any
party authorized to use the invention: Provided,
further, That the right to import the drugs and medicines contemplated in this section shall
be available to any government agency or any private third party;

72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial
purpose: Provided, That it does not significantly prejudice the economic interests of the owner of
the patent;

72.3. Where the act consists of making or using exclusively for experimental use of the invention
for scientific purposes or educational purposes and such other activities directly related to such
scientific or educational experimental use;

72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling
the invention including any data related thereto, solely for purposes reasonably related to the
development and submission of information and issuance of approvals by government regulatory
agencies required under any law of the Philippines or of another country that regulates the
manufacture, construction, use or sale of any product: Provided, That, in order to protect the data
submitted by the original patent holder from unfair commercial use provided in Article 39.3 of
the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the
Intellectual Property Office, in consultation with the appropriate government agencies, shall
issue the appropriate rules and regulations necessary therein not later than one hundred twenty
(120) days after the enactment of this law;

72.5. Where the act consists of the preparation for individual cases, in a pharmacy or by a
medical professional, of a medicine in accordance with a medical shall apply after a drug or
medicine has been introduced in the Philippines or anywhere else in the world by the patent
owner, or by any party authorized to use the invention: Provided, further, That the right to import
the drugs and medicines contemplated in this section shall be available to any government
agency or any private third party; xxx7

The unqualified right of private third parties such as petitioner to import or possess unregistered
imported drugs in the Philippines is further confirmed by the Implementing Rules to Republic Act No. 9502
promulgated on 4 November 2008.8 The relevant provisions thereof read:

Rule 9. Limitations on Patent Rights. The owner of a patent has no right to prevent
third parties from performing, without his authorization, the acts referred to in Section 71 of the
IP Code as enumerated hereunder:

(i) Introduction in the Philippines or Anywhere Else in the World.

Using a patented product which has been put on the market in the Philippines by the
owner of the product, or with his express consent, insofar as such use is performed after that
product has been so put on the said market: Provided, That, with regard to drugs and medicines,
the limitation on patent rights shall apply after a drug or medicine has been introduced in the
Philippines or anywhere else in the world by the patent owner, or by any party authorized to use
the invention: Provided, further, That the right to import the drugs and medicines contemplated
in this section shall be available to any government agency or any private third party. (72.1)

The drugs and medicines are deemed introduced when they have been sold or offered for
sale anywhere else in the world. (n)

It may be that Rep. Act No. 9502 did not expressly repeal any provision of the SLCD. However, it is
clear that the SLCOs classification of unregistered imported drugs as counterfeit drugs, and of corresponding
criminal penalties therefore are irreconcilably in the imposition conflict with Rep. Act No. 9502 since the latter
indubitably grants private third persons the unqualified right to import or otherwise use such drugs. Where a
statute of later date, such as Rep. Act No. 9502, clearly reveals an intention on the part of the legislature to
abrogate a prior act on the subject that intention must be given effect.9 When a subsequent enactment covering
a field of operation coterminus with a prior statute cannot by any reasonable construction be given effect while
the prior law remains in operative existence because of irreconcilable conflict between the two acts, the latest
legislative expression prevails and the prior law yields to the extent of the conflict.10 Irreconcilable
inconsistency between two laws embracing the same subject may exist when the later law nullifies the reason or
purpose of the earlier act, so that the latter loses all meaning and function.11 Legis posteriors priores contrarias
abrogant.

For the reasons above-stated, the prosecution of petitioner is no longer warranted and the quested writ of
prohibition should accordingly be issued.

III.

Had the Court proceeded to directly confront the constitutionality of the assailed provisions of the
SLCD, it is apparent that it would have at least placed in doubt the validity of the provisions. As written, the law
makes a criminal of any person who imports an unregistered drug regardless of the purpose, even if the
medicine can spell life or death for someone in the Philippines. It does not accommodate the situation where the
drug is out of stock in the Philippines, beyond the reach of a patient who urgently depends on it. It does not
allow husbands, wives, children, siblings, parents to import the drug in behalf of their loved ones too physically
ill to travel and avail of the meager personal use exemption allotted by the law. It discriminates, at the expense
of health, against poor Filipinos without means to travel abroad to purchase less expensive medicines in favor of
their wealthier brethren able to do so. Less urgently perhaps, but still within the range of constitutionally
protected behavior, it deprives Filipinos to choose a less expensive regime for their health care by denying them
a plausible and safe means of purchasing medicines at a cheaper cost.

The absurd results from this far-reaching ban extends to implications that deny the basic decencies of
humanity. The law would make criminals of doctors from abroad on medical missions of such humanitarian
organizations such as the International Red Cross, the International Red Crescent, Medicin Sans Frontieres, and
other like-minded groups who necessarily bring their own pharmaceutical drugs when they embark on their
missions of mercy. After all, they are disabled from invoking the bare personal use exemption afforded by the
SLCD.

Even worse is the fact that the law is not content with simply banning, at civil costs, the importation of
unregistered drugs. It equates the importers of such drugs, many of whom motivated to do so out of altruism or
basic human love, with the malevolents who would alter or counterfeit pharmaceutical drugs for reasons of
profit at the expense of public safety. Note that the SLCD is a special law, and the traditional treatment of penal
provisions of special laws is that of malum prohibitumor punishable regardless of motive or criminal intent. For
a law that is intended to help save lives, the SLCD has revealed itself as a heartless, soulless legislative
piece.
The challenged provisions of the SLCD apparently proscribe a range of constitutionally permissible
behavior. It is laudable that with the passage of Rep. Act No. 9502, the State has reversed course and allowed
for a sensible and compassionate approach with respect to the importation of pharmaceutical drugs urgently
necessary for the peoples constitutionally-recognized right to health.

WHEREFORE, the petition is GRANTED in part. A writ of prohibition is hereby ISSUED


commanding respondents from prosecuting petitioner Romeo Rodriguez for violation of Section 4 or Rep. Act
No. 8203. The Temporary Restraining Order dated 15 October 2001 is hereby made PERMANENT. No
pronouncements as to costs.

SO ORDERED.

SECOND DIVISION

GLAXOSMITHKLINE PHILIPPINES, INC., G.R. No. 166924


Petitioner,
Present:

PUNO, J., Chairperson,


- versus - SANDOVAL-GUTIERREZ,
CORONA,
AZCUNA, and
GARCIA, JJ.
KHALID MEHMOOD MALIK and MUHAMMAD
ATEEQUE, Promulgated:
Respondents.
August 17, 2006
x----------------------------------------------------------------------------------------------x
DECISION

GARCIA, J.:

In this petition for review under Rule 45 of the Rules of Court, petitioner GLAXOSMITHKLINE
PHILIPPINES, INC. (Glaxo, hereafter) seeks to nullify and set aside the Decision12 dated October 28, 2004 of
the Court of Appeals (CA) in CA-G.R. SP No. 78646, as reiterated in its Resolution13 of January 24, 2005,
affirming an earlier resolution of the Secretary of Justice which dismissed the petition for review taken by the

12 Penned by Associate Justice Juan Q. Enriquez, Jr., with Associate Justices Salvador J. Valdez Jr. and Vicente Q. Roxas,
concurring. Rollo, pp. 62-69.
13 Rollo, p. 71.
petitioner in I.S. No. 2002-515 (Crim. Case Nos. 02-0699-0701), a prosecution for violation of Republic Acts
(RA) No. 3720 and No. 8230, filed against the herein respondents, Khalid Mehmood Malik and Muhammad
Ateeque, at the instance of the petitioner and others.

The facts:

Acting on separate letter-complaints filed by Glaxo and two (2) other pharmaceutical companies
operating in the country, namely, Pfizer Phil., Inc. (Pfizer) and Roche Phil., Inc. (Roche), to the effect that
respondents were illegally engaged in the sale and distribution of unregistered imported pharmaceutical drugs
at their business establishments in Paraaque City, namely, the World Traders, Inc. and the Sahar International
Trading Center (SITI), the National Bureau of Investigation (NBI) Intellectual Property Rights Division sent NBI
agent Rodolfo Ignacio, accompanied by investigators of the IP Manila Associates, a private investigating firm
hired by Glaxo, Pfizer and Roche, to the respondents place of business in Paraaque City. There, respondent
Muhammad Ateeque allegedly showed the members of the covert team samples of the medicines he was
selling. The samples shown allegedly included imported drugs bearing the brand names of Glaxo, Pfizer and
Roche, which the team found to be without the requisite registration numbers from the Bureau of Food and
Drugs (BFAD).

On June 9, 2002, NBI operatives, again with members of the same private investigating team,
conducted an entrapment operation at the premises of SITI in Paraaque City, during which respondent Malik
was allegedly caught receiving marked money from one of the team members as payment for parallel
imported pharmaceutical products. Then and there, Malik was placed under arrest and brought to the NBI
Headquarters whereat he was found positive for the presence of fluorescent powder. Respondent Ateeque
allegedly left before the buy-bust operation could be effected.

After due examination of the confiscated samples of pharmaceutical products and the drugs allegedly
sold by Malik, petitioner concluded that the same did not conform to Glaxos standards.

The next day, June 10, 2002, Inquest Prosecutor Albert R. Fonacier of the Department of Justice (DOJ)
conducted an inquest investigation of respondent Malik. Thereafter, Criminal Cases No. 02-0699 to No. 0701
for violation of RA No. 3720, also known as the Food, Drugs and Cosmetic Act and RA No. 8203, otherwise
known as the Special Law on Counterfeit Drugs, were filed against Malik before the Regional Trial Court of
Paraaque City, Branch 258. As regards respondent Ateeque who was at large at the time, the court
recommended that he too be preliminarily investigated.

State Prosecutor Isagani Rabe commenced the preliminary investigation of respondent Ateeque. Upon
motion of respondent Malik that his case be reinvestigated together with that of Ateeques, the DOJ
consolidated the preliminary investigation of the complaints against both respondents and had them docketed
as I.S. No. 2002-515.
On January 14, 2003, Senior State Prosecutor Leah C. Tanodra-Armamento issued a resolution14
dismissing the charges against both respondents. Pertinently, the resolution reads:

xxx xxx xxx

Consequently, the affidavits filed by complainant failed to sustain any indictment in the
light of respondents evidence. Worse, it is not consistent with the truth.

xxx xxx xxx

WHEREFORE, premises considered, the foregoing charges against respondents Khalid


Mehmood Malik and Muhammad Ateeque are hereby dismissed for lack of merit.

SO ORDERED.

Petitioner Glaxo moved for a reconsideration but its motion was denied by the same State Prosecutor
in her subsequent resolution of February 18, 2003.

From such denial, petitioner and the other pharmaceutical firms (Pfizer and Roche) went to the
Secretary of Justice on separate petitions for review.

In a Resolution15 dated June 17, 2003, the Justice Secretary dismissed Glaxos petition, saying: We have
examined the record and found no such error committed by the prosecutor that would justify a reversal of the
assailed resolution which is in accord with the law and evidence on the matter.

In yet a similarly worded Resolution16 dated June 25, 2003, the Secretary of Justice dismissed the
other petitions for review of Pfizer and Roche.

Obviously displeased, Glaxo went to the CA on a petition for certiorari in CA-G.R. SP No. 78646,
imputing grave abuse of discretion on the part of the DOJ Secretary in denying its petition for review of the
dismissal resolution, supra, of Senior State Prosecutor Leah C. Tanodra-Armamento.

As stated at the outset hereof, the CA, in the herein assailed Decision17 dated October 28, 2004,
finding no grave abuse of discretion on the part of the Secretary of Justice, denied due course to Glaxos
petition and accordingly dismissed the same, thus:

WHEREFORE, premises considered, the instant petition is hereby DENIED DUE


COURSE and DISMISSED.
SO ORDERED.
In time, petitioner moved for a reconsideration but its motion was denied by the same court in its
Resolution18 of January 24, 2005.

Undaunted, petitioner is now with this Court via the present recourse, raising substantially the same
issue of whether courts may review findings of the prosecutor on the existence of probable cause and substitute
their own judgment for that of the latter in determining sufficiency of evidence to establish guilt.

14 Rollo, pp. 225-230.


15 Rollo, pp. 300-301.
16 Rollo, pp. 302-303.
17 Supra note 1.
18 Supra note 2.
We DENY.

Well-settled is the rule that the courts will not interfere in the conduct of preliminary investigations or
reinvestigations and leave to the investigating prosecutor sufficient latitude of discretion in the determination of
what constitutes sufficient evidence as will establish probable cause for the filing of the corresponding
complaint or information against an offender.19 In fact, the prosecutors findings on the matter are not subject to
review by the courts unless shown to have been made with grave abuse of discretion.20 And by it is meant that
the power is exercised in an arbitrary, capricious, whimsical or despotic manner by reason of passion or
personal

hostility, patent and gross enough as to amount to an evasion of a positive duty or virtual refusal to perform a
duty enjoined by law.21

Here, we failed to discern such abuse. For, as found by Senior State Prosecutor Leah C. Tanodra-
Armamento in her dismissal Resolution22 of January 14, 2003, which was duly sustained by the Secretary of
Justice in his uniformly worded resolutions of June 17, 2003 and June 25, 2003 which denied the separate
petitions for review filed by petitioner Glaxo and others:

To prove their charge, complainants presented the certification of their employees (sic)
alleging that the drugs purchased from respondent on June 9, 2002 do not contain their companys
certificate of product registration issued by BFAD. They, however, admitted that respondents
are into parallel importation of the drugs sold which is now being encourage by the
government to bring down the prices of medicines. In fact, they failed to show that such act
is prohibited by law.

Respondents, to prove the legitimacy of their business, presented a certification from


BFAD that they are duly licensed drug importer/distributor/wholesaler at the same time that
the alleged purchase was made by the complainants. In addition, respondents presented a
certification of BFAD LICD Chief Atty. Ireneo M. Galicia that Sahar International Trading, Inc.
has no pending violation with BFAD as of July 30, 2002 or after the alleged purchase on June 9,
2002. Clearly, the said transaction was not deemed as violation by BFAD, the government
agency mandated to implement R.A. 3720 and R.A. 8203.
Consequently, the affidavits filed by complaint (sic) failed to sustain any indictment
in the light of respondents evidence. Worse, it is not consistent with the truth.
Ateeque presented his passport and the Bureau of Immigration computer print-out of his
arrival on May 29, 2002 to disprove that Ms. Legaspi was able to talk to him on May 28, 2002
and placed an order for the drugs to be purchased. He also presented the affidavit of Mr. Sangca,
a friend with whom his family had dinner during the alleged entrapment operation on June 9,
2002. Further, the Articles of Incorporation of World Traders, Inc. (WTI) was also attached by
respondents to disprove complainants allegation that they met at WTI premises, and to show
incredulity of complainants accusation as the documents show that the corporation was created
even before Ateeque was born with its office located at No. 45 Dallas Street. BF Northwest,
Paraaque City, a place Ateeque had never been to. (Emphasis supplied)

By the nature of his office, the investigating prosecutor is under no compulsion to file criminal
information where no clear legal justification has been shown and where he is not convinced that he has the
quantum of evidence to support the averments.23 Prosecuting officers have the duty not to prosecute when,
after investigation or reinvestigation, they are convinced that the evidence adduced was not sufficient to

19 Rosalinda Punzalan, Randall Punzalan and Rainier Punzalan vs. Dencio Dela Pea and Robert Cagara, G.R. No. 158543,
July 21, 2004, 434 SCRA 601.
20 Cabahug vs. People, G.R. No. 132816, February 5, 2002, 376 SCRA 113.
21 Baylon vs. Office of the Ombudsman and the Sandiganbayan, G.R. No. 142738, December 14, 2001, 372 SCRA 437.
22 Supra note 3.
23 Tam Wing vs. Makasiar, G.R. No. 122452, January 29, 2001, 350 SCRA 475.
establish a prima facie case. This is as it should be. For, the determination of the persons to be prosecuted rests
primarily with the prosecutor who is vested with discretion in the discharge of this function. Hence, the question
of whether or not to dismiss a complaint is within the purview of the functions of the prosecutor and, ultimately,
that of the Secretary of Justice.24
Absent, as here, of any clear showing of arbitrariness, the Court defers to the authority of the
prosecuting arm to determine probable cause in a preliminary investigation and shall give credence to its
findings and determination.
For sure, the Court is consistent in its view that the determination of whether there is reasonable ground
to believe that the accused is guilty of the offense charged and should be subjected to the expense, rigors and
embarrassment of trial is an executive function exclusively of the prosecutor.25

IN VIEW WHEREOF, the instant petition is DENIED.

SO ORDERED.

24 Supra note 1.
25 Sistoza vs. Desierto, G.R. No. 144784, September 13, 2002, 388 SCRA 307.

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