Professional Documents
Culture Documents
Classification as to effectivity:
1. Donor must reserve sufficient means for his support and for his relatives who are entitled
to be supported by him
2. Donation cannot comprehend future property except donations between future husband
and wife
3. No person may give by way of donation more than he may give by will
- Under Article 734 of the Civil Code, a donation is perfected from the moment the donor
knows of the acceptance by the donee.
A. Donor
1. Any person who has the capacity to contract and capacity to dispose of his
property (Art. 735)
2. Capacity shall be determined as of the time of the making/perfection of the
donation (Art. 737)
B. Donee
1. All those who are not especially disqualified by law
2. If no simultaneous delivery:
The donation must be written in a public or private instrument, regardless of
value; otherwise, under the Statute of Frauds, the donation shall be unenforceable
Void Donations
Case:
FACTS:
Petitioner is the registered owner of a parcel of land in Peñafrancia, Naga City. The said parcel
of land was donated to the Camarines Sur Teachers’ Association (CASTEA) through a Deed of
Donation Inter Vivos. The Deed imposed the condition that the land shall be used exclusively for
the construction of buildings which will house the offices of CASTEA and prohibited the sale,
mortgage, or encumbrance of the land. It included an automatic revocation clause.
CASTEA accepted the donation. However, it entered into a lease agreement with Bodega over
the said property for a period of 20 years. Bodega was requested to prove ownership or legal
basis of possessing the subject land. Thereafter, a Deed of Revocation was executed on the
ground that CASTEA violated the conditions in the Deed of Donation.
The MTC ruled in favor of the petitioner and ordered Bodega to vacate the property. The RTC
reversed the MTC ruling, which was thereafter affirmed by the CA.
In its comment, Bodega anchors its right of possession on its Contract of Lease with CASTEA.
ISSUE
RULING
No. CASTEA never contested this revocation. Hence, the property donated reverted back to
Petitioner.
Petitioner merely allowed Bodega to possess the property by tolerance. Several demands to
vacate the land have already been made but Bodega refused to accede thereto.
Moreover, where a donation has an automatic revocation clause, the occurrence of the condition
agreed to by the parties as to cause the revocation, is sufficient for a party to consider the
donation revoked without need of any judicial action.
SAMPLE FORM:
That this DEED OF DONATION, made and entered into by and between:
― and ―
LILY J. CRUZ, Filipino citizen, of legal age, single, with residence at Dumaguete
City, Negros Oriental, Philippines hereinafter referred to as the DONEE:
WITNESSETH:
That the DONOR is the owner of a parcel of land situated at Dumaguete City,
Negros Oriental, Philippines and more particularly described and bounded as follows:
“A parcel of land (Lot _____, Case _____, Cad-_____) under OCT No. ___________ in
the name of ______________________, situated in the ______________________,
bounded on the SW., along line ______ by lot _____, along line ______ by lot ______, on
the NW., on point .... all of Cad-_____, ______________________, containing an area
of ______________________ Square Meters (_____ Sq.m.) more or less. [herein attached
as Annex “A”]”
That for and in consideration of the love and affection of the DONOR for the
DONEE for faithful services rendered by the donee to the donor, the said DONOR hereby
TRANSFERS, GIVES and CONVEYS unto the DONEE, the property above-described,
including all existing improvements found thereon, free from all liens and encumbrances
and charges of whatsoever nature;
That the DONOR hereby states, for the purpose of giving full effect and validity to
this donation, that she has reserved for herself sufficient property, in full ownership or in
usufruct, which is necessary and adequate for her support in consonance with her standing
in society;
That the DONOR further states, for the purpose as expressed in the next preceding
paragraph, that this donation is not made with the object of defrauding her creditors, having
reserved to herself sufficient property to answer for her debts contracted prior to this date;
That the DONEE hereby accepts this donation and hereby expresses gratitude for
the kindness and liberality of the DONOR;
IN WITNESS WHEREOF, the DONOR and the DONEE have hereunto set their
hands on this ________________________ at ______________________, Philippines.
______________________ ______________________
DONOR DONEE
______________________________ ___________________________
Witness Witness
ACKNOWLEDGMENT
personally known to me to be the same persons who executed the foregoing instrument
and being informed by me of the contents of the foregoing instrument, they acknowledged
before me that they executed the same on their own free will and deed.
WITNESS MY HAND AND SEAL on the date and place first above written.
Definition
- Under Section 1, Rule 21 of the Revised Rules of Court, a Subpoena is a process directed
to a person requiring him to attend and to testify at the hearing or the trial of an action, or
at any investigation conducted by competent authority, or for the taking of his deposition.
It may also require him to bring with him any books, documents, or other things under his
control in which case it is called a subpoena ducestecum.
- 2 kinds:
1. Subpoena ducestecum
2. Subpoena ad testificandum
By whom issued
- When the application for a subpoena to a prisoner is made, the judge or officer shall
examine and study carefully such application to determine whether the same is made for
a valid purpose.
- A person present in court before a judicial officer may be required to testify as if he were
in attendance upon a subpoena issued by such court or officer.
Compelling Attendance
- In case of failure of a witness to attend, the court or judge issuing the subpoena, upon
proof of the service thereof and of the failure of the witness, may issue a warrant to the
sheriff of the province, or his deputy, to arrest the witness and bring him before the court
or officer where his attendance is required
- The cost of such warrant and seizure of such witness shall be paid by the witness if the
court issuing it shall determine that his failure to answer the subpoena was willful; and
without just excuse.
- Failure by any person without adequate cause to obey a subpoena served upon him shall
be deemed a contempt of the court from which the subpoena is issued. If the subpoena
was not issued by a court, the disobedience thereto shall be punished in accordance with
the applicable law or Rule.
- Exceptions. – The provisions of sections 8 and 9 of this Rule shall not apply to a witness
who resides more than one hundred (100) kilometers from his residence to the place
where he is to testify by the ordinary course of travel, or to a detention prisoner if no
permission of the court in which his case is pending was obtained.
Case:
FACTS
Respondent Webb is one of the accused in a case for rape with homicide. In the course of the
proceedings in the trial court, respondent filed a Motion to Take Testimony by Oral Deposition
praying that he be allowed to take the testimonies of individuals, all of whom reside in the
United States.
The trial court denied the motion on the ground that it is not allowed under Section 4, Rule 24
and Sections 4 and 5 of Rule 119 of the Rules of Court.
Whether or not the respondent is entitled to secure the attendance of the said witnesses
RULING
No. It needs to be stressed that the only reason of respondent for seeking the deposition of the
foreign witnesses is "to foreclose any objection and/or rejection of, as the case may be, the
admissibility of Defense Exhibits "218" and "219"." This issue has, however, long been rendered
moot and academic by the admission of the aforementioned documentary exhibits by the trial
court in its order dated July 10, 1998.
The trial court was but exercising its judgment on what it perceived to be a superfluous exercise
on the belief that the introduction thereof will not reasonably add to the persuasiveness of the
evidence already on record.
Under the circumstances, we sustain the proposition that the trial judge commits no grave abuse
of discretion if she decide that the evidence on the matter sought to be proved in the United
States could not possibly add anything substantial to the defense evidence involved. There is no
showing or allegation that the American public officers and the bicycle store owner can identify
respondent Hubert Webb as the very person mentioned in the public and private documents.
Neither is it shown in this petition that they know, of their own personal knowledge, a person
whom they can identify as the respondent-accused who was actually present in the United States
and not in the Philippines on the specified dates.
SAMPLE FORM:
EMILIA R. ARDIENTE
Plaintiff, CIVIL CASE NO. ___
For: Unlawful Detainer
-versus-
JULIO J. CRUZ,
Defendant.
x---------------------x
GREETINGS:
The undersigned will pay the legal fees for such purpose.
(SIGNATURE OF COUNSEL)
Petition for Prohibition
Rule 65, Section 2. Petition for prohibition. — When the proceedings of any tribunal,
corporation, board, officer or person, whether exercising judicial, quasi-judicial or ministerial
functions, are without or in excess of its or his jurisdiction, or with grave abuse of discretion
amounting to lack or excess of jurisdiction, and there is no appeal or any other plain, speedy, and
adequate remedy in the ordinary course of law, a person aggrieved thereby may file a verified
petition in the proper court, alleging the facts with certainty and praying that judgment be
rendered commanding the respondent to desist from further proceedings in the action or matter
specified therein, or otherwise granting such incidental reliefs as law and justice may require.
3. and a sworn certification of non-forum shopping as provided in the third paragraph of section
3, Rule 46.
Dolot vs. Paje, etc., et al.
Facts: Dolot, et al, filed the aforesaid petition with the RTC of Sorsogon alleging that mining
operations conducted by Antones Enterprises, Global Summit Mines Development
Corpororation puts the Municipality of Matnog in environmental dangers and despite this fact,
Sorsogon Governor Raul Lee and his predecessor Sally Lee issued to the operators a small-scale
mining permit.
Similarly, it was alleged that representatives of PMS and DENR did nothing to protect the
interest of the people in same community, thus, respondents violated R.A. No. 7076 or the
People’s Small-Scale Mining Act of 1991, R.A. No. 7942 or the Philippine Mining Act of 1995,
and the Local Government Code. Dolot, et al primarily prayed for the shutdown of said mining
operations through issuance of TEPO as well as the rehabilitation of the mining sites and the
return of the iron ore mined in the area.
The case was referred by the Executive Judge to the RTC of Sorsogon, Branch 53 being the
designated environmental court. However, the case was summarily dismissed for lack of
jurisdiction.
The RTC averred that SC Administrative Order (A.O.) No. 7 and Admin. Circular No. 23-2008
limit the power of such court to try and hear the case as its territorial jurisdiction was limited to
violations of environmental laws within the boundaries of Sorsogon City and the neighboring
municipalities of Donsol, Pilar, Castilla, Casiguran and Juban.
Issue: Whether the RTC-Branch 53 has jurisdiction to resolve Civil Case No. 2011-8338.
Held: Yes. The SC held that such reasoning is plainly erroneous and that RTC cannot solely rely
on SC A.O. No. 7 and Admin. Circular No. 23-2008 and confine itself within its four corners in
determining whether it had jurisdiction over the action filed by the petitioners.
As reiterated by the SC, jurisdiction is the power and authority of the court to hear, try and
decide a case, is conferred by law. It may either be over the nature of the action, over the subject
matter, over the person of the defendants or over the issues framed in the pleadings. BP Blg. 129
or the Judiciary Reorganization Act of 1980 also states that jurisdiction over special civil actions
for certiorari, prohibition and mandamus is vested in the RTC, hence, original jurisdiction shall
be exercised by the RTCs.
Both the SC AO and AC merely provide for the venue where an action may be filed. The Court
does not have the power to confer jurisdiction on any court or tribunal as the allocation of
jurisdiction is lodged solely in Congress and the same cannot be delegated to another office or
agency of the Government
The high court further emphasized that venue relates only to the place of trial or the geographical
location in which an action or proceeding should be brought and does not equate to the
jurisdiction of the court as it is aimed to accord convenience to the parties, as it relates to the
place of trial, and does not restrict their access to the courts.
Therefore, RTC’s motu proprio dismissal of the case on the ground of lack of jurisdiction is
incorrect. While it appears that the alleged actionable neglect or omission occurred in the
Municipality of Matnog and as such, the petition should have been filed in the RTC of Irosin, it
does not warrant the outright dismissal of the petition by the RTC as venue may be waived.
Moreover, the action filed by the petitioners is not criminal in nature where venue is an essential
element of jurisdiction. With these, the SC granted the petition and directed the Executive Judge
of the Regional Trial Court of Sorsogon to transfer the case to the RTC of Irosin, Branch 55, for
further proceedings with dispatch.
SAMPLE FORM:
ANDRES BONIFACIO
Petitioner,
Incidental reliefs as law and justice may require are likewise prayed for.
SUBSCRIBED and sworn to before me, this 13thday of March 2017, in the City of
Quezon by ANDRES BONIFACIO with Passport No. 30111863 issued on 10th of May 2016at
Department of Foreign Affairs - Ali Mall.
ApolinarioMabini, Esq.
Counsel for the Respondent
Mabini Law, Kalayaan Street
Barangay Socorro, Quezon City
Petition for Mandamus
Rule 65, Section 3. Petition for mandamus. — When any tribunal, corporation, board, officer
or person unlawfully neglects the performance of an act which the law specifically enjoins as a
duty resulting from an office, trust, or station, or unlawfully excludes another from the use and
enjoyment of a right or office to which such other is entitled, and there is no other plain, speedy
and adequate remedy in the ordinary course of law, the person aggrieved thereby may file a
verified petition in the proper court, alleging the facts with certainty and praying that judgment
be rendered commanding the respondent, immediately or at some other time to be specified by
the court, to do the act required to be done to protect the rights of the petitioner, and to pay the
damages sustained by the petitioner by reason of the wrongful acts of the respondent.
The petition shall also contain a sworn certification of non-forum shopping as provided in the
third paragraph of section 3, Rule 46. (3a)
The petition shall be filed not later than sixty (60) days from notice of the judgment,
order or resolution.
In case a motion for reconsideration or new trial is timely filed, whether such motion is
required or not, the sixty (60) day period shall be counted from notice of the denial of said
motion.
It may also be filed with the Court of Appeals or with the Sandiganbayan, whether or not
the same is in aid of the courts appellate jurisdiction.
Facts: Municipal Mayor of Nagcarlan, Laguna Rosendo Corales appointed Dr. Rodolfo Angeles
as Municipal Administrator. The appointment was unanimously approved by the Sangguniang
Bayan during his first term as Mayor but was disapproved during his 2nd-3rd term.
Provincial State Auditor Maximo Andal, after auditing local disbursements issued Audit
Observation Memorandum to Corales seeking his comment/reply regarding Angeles'
appointment and his emoluments. One of the recommendations in the AOM was for Corales,
being the appointing authority to be liable to pay for Angeles’ salaries.
Instead of replying, Corales filed with the RTC petition for prohibition and mandamus against
Andal and the Sanggunian to recall the AOM and desist from collecting from him. RTC decided
in favor of Corales. Republic, as represented by COA, filed petition for certiorari in CA ascribing
grave abuse of discretion amounting to lack or excess of jurisdiction. CA granted certiorari and
annulled the RTC order and dismissed the prohibition. Corales filed certiorari under Rule 45 to
nullify CA decision.
Issue: Whether the CA erred in ordering the dismissal of Corales’ action for prohibition.
Held: No, the CA's dismissal is correct. Corales insist that it is no longer necessary to
exhaust administrative remedies considering that there is no appeal or any other plain,
speedy and appropriate remedial measure to assail the imposition under the AOM aside from
an action for prohibition.
Corales was simply required to submit his comment/reply on the observations stated in the
AOM. The issuance of the AOM is just an initiatory step in the investigative audit being
conducted by Andal as Provincial State Auditor to determine the propriety of the disbursements
made by the Municipal Government of Laguna.
Prohibition, being a preventive remedy to seek a judgment ordering the defendant to desist from
continuing with the commission of an act perceived to be illegal, may only be resorted to when
there is “no appeal or any other plain, speedy, and adequate remedy in the ordinary course of
law.”
His action for prohibition was premature. The audit investigative process was still in its initial
phase. There was yet no Notice of Disallowance issued. And, even granting that the AOM issued
to petitioner Corales is already equivalent to an order, decision or resolution of the Auditor or
that such AOM is already tantamount to a directive for petitioner Corales to reimburse the
salaries paid to petitioner Dr. Angeles, still, the action for prohibition is premature since there are
still many administrative remedies available to petitioners to contest the said AOM.
INTERPLEADER
What is interpleader?
When interpleader proper.— Whenever conflicting claims upon the same subject matter
are or may be made against a person who claims no interest whatever in the subject
matter, or an interest which is whole or in part is not disputed by the claimants, he may
bring an action against the conflicting claimants to compel them to interplead and litigate
their several claims among themselves.
Interpleader is a remedy whereby a person who has a property in his possession or has an
obligation to render wholly or partially, without claiming any right in both, comes to court and
asks that the defendants who have made upon him conflicting claims upon the same property or
who consider themselves entitled to demand compliance with the obligation be required to
litigate among themselves in order to determine who is entitled to the property or payment of the
obligation. (Beltran v. PHHC, G.R. No. L-25138, August 28, 1969)
1. There must be two or more claimants with adverse or conflicting interests to a property in
the custody or possession of the plaintiff;
2. The plaintiff has no claim upon the subject matter of the adverse claims, or if he has an
interest at all, such interest is not disputed by the claimants; and
3. The subject matter of the adverse claims must be one and the same.
Under the Civil Code of the Philippines, a cardinal principle to be observed for the validity of
payment or performance is that payment must be made “to the person in whose favor the
obligation was constituted.” (Art. 1240)
This means that as a rule, payment to the wrong person is not a valid payment and does not
extinguish the obligation.
Where to File?
Municipal Trial If the subject matter of the If the subject matter of the
Court (MTC) action is personal property, action is personal property,
valued at not more than valued at not more than
P20,000.00 P50,000.00
Regional Trial Court If the subject matter of the If the subject matter of the
(RTC) action is real property with an action is real property with
assessed value at not more an assessed value at not
than P300,000.00 more than P400,000.00
How to File?
DETERMINATION
Court shall determine
conflicting claimants’
respective rights and
adjudicate their
several claims.
[SAMPLE FORM]
COMPLAINT IN INTERPLEADER
1. Plaintiff and defendants are all of legal age; plaintiff resides at ________________
while defendants reside at _______________ and _______________, respectively, where they
may be served with pertinent notices.
2. On 11January 2018, plaintiff found a Gold Rolex Oyster watch, without knowing who
its true owner is. The watch is now in plaintiff’s possession. On or about 5 March2018,
defendants made similar representations to plaintiff as to ownership of the watch.
3. Plaintiff, who claims no interest in the watch, cannot determine the conflicting claims
of defendants and thus seeks to compel defendants to interplead and litigate their several claims
between themselves.
VERIFICATION / CERTIFICATION
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.
__________
Affiant
SUBSCRIBED AND SWORN to before me this 20th day of April 2018 in
Makati City, affiant exhibited to me his Driver’s License No. 011-X01-96-031653,
expiring on May 11, 2020.
Notary Public
Doc. No. ____;
Page No. ____;
Book No. ____;
Series of 2006.
DECLARATORY RELIEF
Section 1, Rule 63.—Any person interested under a deed, will, contract or other written
instrument, or whose rights are affected by a statute, executive order or regulation, ordinance or
any other governmental regulation may, before breach or violation thereof, bring an action in the
appropriate Regional Trial Court to determine any question of construction or validity arising,
and for a declaration of his rights or duties thereunder.
An action for the reformation of an instrument, to quiet title to real property or remove clouds
therefrom, or to consolidate ownership under Article 1607 of the Civil Code, may be brought
under this Rule.
Where to File?
To determine which court has jurisdiction over the actions identified in the second paragraph of
Section 1, Rule 63 of the Rules of Court, said provision must be read together with those of the
Judiciary Reorganization Act of 1980, as amended.
Section 33 of the said Act explicitly requires the MTC to exercise exclusive original jurisdiction
over all civil actions which involve title to or possession of real property where the assessed
value does not exceed P20,000.00, or in civil actions in Metro Manila, where such assessed value
does not exceed P50,000.00, exclusive of interest, damages of whatever kind, attorney’s fees,
litigation expenses and costs.
When to File?
An action for declaratory relief presupposes that there has been no actual breach of the
instruments involved or of rights arising thereunder. Since the purpose of an action for
declaratory relief is to secure an authoritative statement of the rights and obligations of the
parties under a statute, deed, or contract for their guidance in the enforcement thereof, or
compliance therewith, and not to settle issues arising from an alleged breach thereof, it may be
entertained only before the breach or violation of the statute, deed, or contract to which it refers.
Requisites
(1) Subject matter of controversy is a deed, will, contract, or other written instrument, statute,
executive order, or regulation, or ordinance;
Court may refuse to adjudicate where decision would not terminate the uncertainty or
controversy which gave rise to the action OR where the declaration is not necessary and proper
at the time;
(2) Terms and validity thereof are doubtful and require judicial construction;
(3) No breach of the document, otherwise ordinary civil action is the remedy;
Must be before breach is committed, as in the case where the petitioner paid under protest the
fees imposed by an ordinance. Declaratory relief still proper because the applicability of the
ordinance to future transactions still remains to be resolved, although the matter could be
threshed out in an ordinary suit for the recovery of the fees paid.
(4) There is an actual justiciable controversy between persons whose interests are adverse;
(5) The same is ripe for adjudication;
(6) Adequate relief is not available through other means or other forms of action or
proceeding.
[SAMPLE FORM]
- 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
Parties
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.”
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.
Discussion
15. The subject matter of this instant Petition is Article 39.3 of the TRIPS
Agreement, which states, to wit:
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:
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.
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 exclusivity” or “market
exclusivity” over test data submitted to the BFAD for marketing approval.
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 exclusivity” in the subject article.
Second, a cursory reading of Article 39.3’s provision reveals the following:
(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.
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 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
(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.
By:
Ferdinand M. Negre
Jonathan Q. Perez
VERIFICATION / CERTIFICATION
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.
Sam Gioskos
Affiant
Notary Public
Doc. No. ____;
Page No. ____;
Book No. ____;
Series of 2006.