Trademark Final - Chikit

7/27/2019 Trademark Final - Chikit

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Semester, 2013 PABILANE, Frances Lipnica

Atty. Antonio Ray Ortiguera

1

The Philippine Pharmaceutical Industry through Rose-Colored Spectacles:

Cheap Medicines Act vis--vis the Intellectual Property Code

Frances Lipnica Pabilane

Introduction

The paper aims to illustrate how the Philippine legal framework is able to balance thegovernments duty to promote health

1and public welfare, with the constitutional

2and statutory

right of persons, whether natural or juridical, to intellectual property rights. In analysing theconstitutional mandate, the paper will cover the pertinent provisions of both international anddomestic legal system. The international law applicable would primarily pertain to the

Agreement on Trade-Related Aspects of Intellectual Property Rights3

(TRIPS). The authordecided to consult with relevant laws and jurisprudence of other states and regional organizations

that have persuasive effect to the Philippine legal system. The domestic laws to be examinedinclude the Intellectual Property Code vis--vis the promulgated law on Access to Cheaper

Medicine.

The paper is divided into five parts. The first part of the paper is about the pharmaceutical

industry using the intellectual property law as framework of the discussion. This includesanalysis of the dynamics of pharmaceutical companies with the laws on patent, compulsory

licensing and parallel importation. The second part of the paper discusses the concept of theBolarExemption. This includes the introduction of the etymology of the term which traces its

roots from American jurisprudence. This part of the paper will also present the international andregional bases of this exception. The next part of the paper will tackle the Access to Cheaper

Medicine Act, a law supporting the exception of health as a more compelling interest over

intellectual property rights. This law is labelled as the Philippine version of the Bolar Exemption.The fourth division shows the legal trend among other areas of law, where health and medicalresearch are tagged as exceptions to the rule covered by the general provisions. The last part of

the paper is the analysis and conclusion. This part will present a brief summary of the precedingdivisions of the paper. The author opines that the higher level of importance accorded the public

health over the intellectual property rights of the pharmaceutical industry should go beyondsuperficial legislation in order to meet the public interest ends and satisfy the due process

requirement in the deprivation of constitutional right to property.

1 According to Section 11, Article XIII of the 1987 Constitution , The state shall adopt an integrated and

comprehensive approach to health development which shall endeavour to make essential goods, health and other

social services available to all people at affordable cost. Furthermore, Section 12 of the same Article provides,

The State shall establish and maintain an effective food and drug regulatory system and undertake appropriatehealth, manpower development, and research, responsive to the countrys health needs and problems.

2 TheBill of Rightsprovides, No person shall be deprived of life, liberty, or property without due process of law,

nor shall any person be denied the equal protection of the laws. 3 The agreement which took effect on January 1, 1995, is an international agreement on intellectual property rights

which covers member countries of the WTO.


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Pharmaceutical Products and Intellectual Property Law: Patenting, Compulsory Licensing

and Parallel Importation

Patent

A patent is granted by the government to protect new and useful inventions. By virtue of

this right, the patentee is able to exclude others from making, offering for sale, using or sellingan invention.4 The Intellectual Property Code of the Philippines, also known as Republic Act No.

8293 (R.A. 8293) includes any technical solution of a problem in any field of human activitywhich is new, involves an inventive step and is industrially applicable

5as patentable. As a

general rule, the patent of pharmaceutical products accords present rights to the patentee anddeals with sustainability of the invention by making sure that the salient information will be used

by the public after the expiration of the patent. As adapted by Pearl & Dean (Phil.),Incorporated v. Shoemart, Incorporated

6:

The patent law has a three-fold purpose: "first, patent law seeks to foster

and reward invention; second, it promotes disclosures of inventions tostimulate further innovation and to permit the public to practice the

invention once the patent expires; third, the stringent requirements forpatent protection seek to ensure that ideas in the public domain remain

there for the free use of the public."7

Under Section 72 of the same Code, the law explains the limitations of patent rights on

drugs and medicines after a drug or medicine has been introduced in the Philippines or anywhereelse in the world by the patent owner, or by any party authorized to use the invention.

8

Application for patents are done through the Intellectual Property Office of the Philippines(IPO).The term of protection awarded the patentee is 20 years which accords the inventor

pecuniary and commercial gain. The patent owner shares the full description of the invention andthis data can be used for future research after the period of exclusive use expires.

9

Compulsory L icensingCertain flexibilities on the application of the stringent rules on intellectual property are

recognized by international agreements. To give an example, the Doha declaration on TRIPS

provides that member states are allowed to utilize compulsory license during health crises andemergency to supply sufficient medicine to the public.

10Compulsory licensing is explicitly

recognized by the Philippine IP Code. Compulsory license is a grant given by the government infavour of any person who has shown the capability to exploit the invention under certain

4William Borchard. (2012). A Trademark is not a copyright or a patent. Cowan, Liebowitz & Latman, P.c., New

York.5

Intellectual Property Code of the Philippines [INTELLECTUAL PROPERTY CODE], R.A. 8293, Section 21.6Pearl Dean (Phil.), Incorporated v. Shoemart, Incorporated and North Edsa Marketing, Incorporated, 409 SCRA

231, August 15, 2003.7 The case citesAronson v. Quick Point Pencil Co., 440 U.S. 257, 262 [1979], citingKewanee Oil Co. v. Bicron

Corp., 416 U.S. 470 [1994], cited Amador, patents, p, 496.8 Intellectual Property Code, Sec. 72.9About Patents. Intellectual Property Office. Accessed on 8 October 2013, from

http://www.ipophil.gov.ph/index.php/patents.10 Manthan, Janodia. (2008). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical

Sector. Vol. 7, Issue 1, Journal of Third World Medicine.
http://www.ipophil.gov.ph/index.php/patents.http://www.ipophil.gov.ph/index.php/patents.http://www.ipophil.gov.ph/index.php/patents.


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circumstances.11One recognized circumstance is public interest, in particular, national security,nutrition, health.

12Pursuant to the power of the government to pursue public interest, the

legislative branch enacted Republic Act No. 9502, also known as the Universally AccessibleCheaper and Quality Medicines Act of 2008. This law will be more comprehensively discussed

in the succeeding sections of this paper. It should be noted that as opposed to patents and parallel

importation, the Philippine Supreme Court is yet to decide a case on compulsory licensing basedon R.A. No. 9502.

Parallel Importation

Parallel importation is also a relevant topic in the Philippine drug industry. According toSolid Triangle v. Sheriff of RTC QC, aparallel importer is one which imports, distributes, and

sells genuine products in the market, independently of an exclusive distributorship or agencyagreement with the manufacturer.

13In the pharmaceutical industry, parallel importation

involves the purchase of a patented drug from an approved source in an exporting country whereit can be acquired more cheaply, without the consent of the patent holder in the importing

country.14

Parallel importation is supported by Article 31(5) of TRIPS which allows memberstates to enforce flexibilities in the enforcement of intellectual property rights when there is a

national emergency or other circumstances of urgency. Parallel imports are also called grey-market imports. These imports do not involve the importation of counterfeit products or illegal

copies.15

As defined by the World Trade Organization (WTO), These are products marketed bythe patent owner (or trademark or copyright owner, etc) or with the patent owners permission in

one country and imported into another country without the approval of the patent owner.16

The Bolar Exemption

The Bolar Exemption has its legal basis in Article 30 of TRIPS which provides the

exceptions to rights conferred the patentees. The provision states, Members may provide limitedexceptions to the exclusive rights conferred by a patent, provided that such exceptions do notreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice

the legitimate interests of the patent owner, taking account of the legitimate interests of thirdparties.

17The Bolar Exemption, although may be characterized as a unilateral act of the

government because it does not require the consent of the patentee, does not unjustly disregardthe economic rights of the patent grantee. The exemption is about striking a convergence

between the promotion of invention and the accessibility of cheaper medicine which is animportant factor in sustaining a healthy population. The milestone achievement created by the

Bolar Exemption is the allowance of acts of experimentation and research even before the

11 Intellectual Property Code, Sec. 93.12 Intellectual Property Code, Sec. 93.2.13Solid Triangle v. Sheriff of RTC QC, G.R. No. 144309, November 23, 2011.14 Tove Gerharsen. (2006). Pfizer Fights IP Flexibilities in the Philippines. Accessed on 8 October 2013, from

http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/.15 World Trade Organization. (2006). TRIPS Pharmaceutical Patents Obligations and Exceptions.16Id.17 Trade Related Aspects of Intellectual Property Rights [TRIPS], Art. 31.
http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/


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expiration of the patent of a pharmaceutical product.18 In developing countries like thePhilippines, this is a necessary government intervention to also protect the rights of majority of

the Filipinos who normally would not have access to expensive medicinal products.

In the international arena, both developed and developing states have acknowledged the

importance of the Bolar Exemption for the promotion of human health and medical research. In aGovernment Response published by the Intellectual Property Office of the United Kingdom in

2013, the Government accepted that section 60(5) of the Patents Act of 1977 shouldaccommodate the exemption from infringement, the activities involved in the preparation or

running of clinical or field trials involving innovative drugs.19

Furthermore, the GovernmentResponse opted for the inclusion of the activities involved in health technology assessment

(HTA).20

The state is on its way to developing amendments to the laws governing intellectualproperty on pharmaceutical products.

The Bolar provision of the European Union is also known as Directive 2004/27/EC. This

is the directive on the amendments on the Community Code relating to medicinal products forhuman use. By virtue of the directive, the rights granted to the patentee by virtue sta tes laws on

patents and utility model do not extend to trials and studies as defined by the directive. Thedirective is of extreme significance because prior to its enactment (before 19 November 2005),

clinical studies and other relevant processes for the development and innovation of genericmedicine could be tantamount to a patent infringement.21 The directive is labelled as an upside to

the manufacturers of generic drugs while also considered as downside from the perspective ofthe mainstream pharmaceutical companies.

22The implementation of the Bolar provision in the

European Union shows the support of the intergovernmental entity to the value of innovationsthat are not barred by technicalities governing patent laws.

The application of the Bolar Exemption can have serious consequences to the mainstream

pharmaceutical companies. In a press release created by Novartis, the corporation manifested its

proactive cooperation to the exemption:

The manufacture, sale, use or importation of a patented product withoutpermission by the patentee constitutes infringement in most countries.The Safe Harbor exemption is an exception to this rule. It is widely

accepted that patents are an instrument to promote and not to hinderresearch activities. xxx Clinical trials for both generics and innovative

medicines should be exempt in the interest of bringing new innovative

18Manthan, Janodia. (2008). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical

Sector. Vol. 7, Issue 1, Journal of Third World Medicine.19 Intellectual Property Office of the United Kingdom. (2013). The Research and Bolar Exception: Proposals to

exempt clinical and field trials using innovative drugs from patent infringement.20Id.21 CMS. (2007). Bolar Provision and Regulatory Data Exclusivity in Europe. Accessed on 8 October 2013, from

http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-

076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-

0bac21c0b232/BolarProvisioninEU.pdf.22 Gwyn Cole.Exemption from Infringement: the EU Bolar Directive. IP Europe Quarterly. Accessed on 8 October

2013, fromhttp://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.
http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf.


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and affordable medicines to the patients without any unreasonable delays

due to patent protection.23

In another state, Pfizer, another international pharmaceutical company questioned the

retroactivity of the Bolar Exemption.24

The Supreme Court of Spain decided in favour of Spainand confirmed that the Bolar provision which was incorporated in Spanish laws in 2006 has a

non-retroactive character. Therefore, prior to its enactment in 2006, the Bolar exemption did notexist in the Spanish jurisdiction.25

Universally Accessible, Cheaper and Quality Medicines Act of 2008

Based on studies, drugs in the Philippines are more expensive that drugs in other Asiancountries of similar economic status. Because of this data, the government was impelled to

institute the Cheaper Medicines Program through the Universally Accessible, Cheaper andQuality Medicines Act of 2008 which provided for the prominent legal bases for parallel

importation

26

and improved production of generic drugs.

27

It cannot be avoided that because ofthe controversial amendments introduced by the law, the constitutionality of the provisions has

been challenged by interested parties. The validity of the provision on parallel importation hasbeen affirmed in the case ofRoma Drug v. RTC of Guagua28, which recognized the legality of

grey importation as supported by the amendment to Section 72.1 of the Intellectual PropertyCode and the Implementing Rules

29of R.A. No. 9502.

In the same manner, this law is instrumental in the allowance of research and laboratory

trials even prior to the expiration of patent, pursuant to the regulations to be imposed by the

23 Novartis. (2011). Safe Harbor Exemption (Bolar Provision).24 Hogan Lovells. (2010). Spanish Supreme Court rules on Bolar and experimental research exemption. Accessed

on 8 October fromhttp://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.25Id.26 Under Section 7 of R.A. No. 9502, 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 onpatent 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.27

Oscar Picazo.Review of the Cheaper Medicines Program of the Philippines. Philippine Institute for Development

Studies.28

Roma Drug v. Regional Trial court of Guagua, G.R. No. 149907, April 16, 2009.29

TheImplementing Rules of R.A. No. 9502says, Rule 9. Limitations on Patent Rights. The owner of a patent hasno 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).
http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.http://www.lexology.com/library/detail.aspx?g=20f5c6aa-fa61-47d1-b680-d632f76110ce.


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government. The Bolar counterpart is found in Section 7 of R.A. No. 9502 which provides anamendment to the IP Code.

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 governmentregulatory agencies required under any law of the Philippines or ofanother 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 Article39.3 of the Agreement on Trade-Related Aspects of Intellectual Property

Rights (TRIPS Agreement), the Intellectual Property Office, inconsultation with the appropriate government agencies, shall issue theappropriate rules and regulations necessary therein not later than one

hundred twenty (120) days after the enactment of this law.30

R.A. No. 9502 also expressly amended the Generics Act of 1988. In a commentary from an

Intellectual Property Law Firm31

, the commentator differentiated the Cheaper Medicines Actwith the Generics Act:

The new law now allows local generic companies to start studying andtesting generic equivalents of patented drugs before the expiration of the

patent. This will also allow pharmaceutical companies to start theproduction and sale of a generic drug upon the patent. Under the old law,this preparation could only be done after the patent has expired. The

whole process of obtaining approval for the drug, takes roughly about

three years, effectively delaying the introduction of the generic in the

market. In this manner, therefore, a patent-holders monopoly in localcommerce over the drug, and any of its equivalents, were inadvertently

extended by this period, outside the duration guaranteed the patent-holder by the law.32

Medicine and Health as Exceptions: Other Areas of Law

Matters relating to medicine and research for the improvement of health condition are

recognized exceptions among laws, not just on intellectual property but also on competition andprivacy. The domestic and international laws and policies recognize the prime importance of

health. The vital significance of the human person goes beyond the property rights of inventorsand allows for the relaxation of strict rules on intellectual property when the public interest is at

stake. This part of the paper will discuss theData Privacy Act of 2012 and theASEAN RegionalGuidelines on Competition Policytwo areas that acknowledge the transcendental importance of

30 Intellectual Property Code, Sec.7.31 Bengzon Negre Untalan (BNU) is a law firm focused ont he practice of intellectual property law in the

Philippines.32 K.P. Ambrocio. (2009). The Bolar Exception: Roots and Introduction to the Philippine Patent System. Accessed

on 8 October 2013 fromhttp://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-

System.html.
http://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.http://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.http://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.http://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.http://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.


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human life as opposed to the inventors rights of pharmaceutical companies to privacy andmarket competition.

Within the purview of the law on privacy, there are two primary uses of personal data

within the pharmaceutical industry: biomedical research and pharmacovigilance. On the onehand, biomedical research recognizes that life-saving treatments available today were made

possible by an environment that fostered medical research. Pharmaceutical companies collectpatient health information created in controlled research settings.

33On the other hand,

pharmacovigilance is the science of activities relating to the detection, assessment, understandingand prevention of drug adverse effects or any other drug-related problem.

34The Data Privacy

Act recognizes that it is the policy of the State to protect the fundamental human right ofprivacy, of communication while ensuring free flow of information to promote innovation and

growth.35

The flow of ideas for the propagation of intellectual growth for public welfare shouldnever be hampered. This is another field of law where disclosure is favored over secrecy in orderto serve public interest.

Competition laws also provide for exceptions to pharmaceutical products and medical

research. This further reiterates the importance of public health that should be given properattention. Under Section 3.5.6 of theASEAN Regional Guidelines on Competition Policy, AMSsmay use block exemptions xxx to exempt specific sectors and/or types of economic activities

from the application of competition law. Examples of common industries or activities which maybe granted block exemptions include research and development cooperation, and intellectual

property rights contracts.36

The regional block of the Southeast Asian nations also recognizethat exceptions to the competition policy can be made if based on public policy

37grounds.

Analysis and Conclusion

An analysis of the exceptions and exemptions granted by the Cheaper Medicines Actreaffirms the essential role that public health plays to achieve public welfare. Indeed, the

legislation on the promotion of medical research and clinical trials even when there is an existingpatent is primarily rooted on the desire to make pharmaceutical products more accessible to the

public. In spite of the genuine communal benefit that is aimed to be achieved by the law, thewords framed by the legislature should be fitted with the reality experienced by the consumers.

To give an illustration, surveys should be conducted in order to determine whether or not theimplementation of the law is appropriate its objectives. Otherwise, the government intervention

might be tantamount to lost revenues for mainstream pharmaceutical industries without reapingthe benefits on the other end of the pole. The government is also bound to respect the property

rights of pharmaceutical companies over their inventions. It is only when two conflicting

interests need to be decided upon, that public health is given more weight.

33 International Pharmaceutical Privacy Consortium, 6 March 2012.34 Rules and Regulations Implementing Republic Act No. 9711, Sec. 5 (ff).35 Data Privacy Act of 2012, R.A. No. 10173, Sec. 2.36 Association of Southeast Asian Nations. (2010). ASEAN Regional Guidelines on Competition Policy.37Section 3.5.1.4 of the ASEAN Regional Guidelines on Competition Policy states that "Prohibitions may not apply

to agreements or conduct based on specific public policy grounds."


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As of press time, the use of generic medicine across the country may be prevalent butthere are valid criticisms

38that need to be addressed in order to ensure a more efficient

implementation. The effectiveness of the provision on compulsory licensing as provided by theCheaper Medicines Act is yet to be proven. The lack of sufficient basis to evaluate compulsory

licensing can be attributed to the fact that the Philippines has not recently experienced health

crisis that is sufficient for a compulsory license to be granted. Viewing the health condition andthe need for accessible and cheaper medicine in the Philippine setting using the framework of theCheaper Medicines Act and its amendment to the IP Code is akin to perceiving reality through

rose-colored spectacles. On the one hand, there are times when the Philippine situation shouldbe analysed with a naked eye. On the other hand, is the recognition that the government with its

three branches, is capable of making the rose-colored spectacles more vibrantly red byensuring that appropriate legislations are implemented effectively.

References

Primary Sources

1987 Philippine Constitution.Data Privacy Act of 2012, R.A. No. 10173.

Intellectual Property Code of the Philippines, R.A. 8293.Implementing Rules of R.A. No. 9502.

Rules and Regulations Implementing Republic Act No. 9711.Association of Southeast Asian Nations. (2010). ASEAN Regional Guidelines on Competition

Policy.Trade Related Aspects of Intellectual Property Rights (TRIPS).

Pearl Dean (Phil.), Incorporated v. Shoemart, Incorporated and North Edsa Marketing,Incorporated, 409 SCRA 231, August 15, 2003.

Solid Triangle v. Sheriff of RTC QC, G.R. No. 144309, November 23, 2011.

Roma Drug v. Regional Trial court of Guagua, G.R. No. 149907, April 16, 2009.

Secondar y Sources

Ambrocio, K. (2009). The Bolar Exception: Roots and Introduction to the Philippine PatentSystem. Accessed on 8 October 2013 fromhttp://www.iplaw.ph/ip-views/The-Bolar-Exception-Introduction-Philippine-Patent-System.html.

Borchard, W. (2012).A Trademark is not a copyright or a patent. Cowan, Liebowitz & Latman,

P.c., New York.CMS. (2007). Bolar Provision and Regulatory Data Exclusivity in Europe. Accessed on 8

October 2013, from http://www.cms-

38 In an article by Satur Ocampo with the Philippine Star last June 9, 2012, he suggested a review in the

implementation of R.A. No. 9502 because the it hasn't served the poor. The article is entitled "Cheaper medicines

law hasn't served the poor" which can be accessed at http://www.philstar.com/opinion/2012-06-

09/815179/cheaper-medicines-law-hasnt-served-poor.
http://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poorhttp://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poorhttp://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poorhttp://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poorhttp://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-served-poor


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cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e-7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5-b970-4fa2-9d61-

0bac21c0b232/BolarProvisioninEU.pdf.Cole, G. Exemption from Infringement: the EU Bolar Directive. IP Europe Quarterly. Accessed

on 8 October 2013, from http://www.avidity-ip.com/assets/pdf/BolarJun12.pdf.

Gerharsen, T. (2006). Pfizer Fights IP Flexibilities in the Philippines. Accessed on 8 October2013, from http://www.ip-watch.org/2006/04/30/pfizer-fights-ip-flexibilities-in-the-philippines/.

Intellectual Property Office. About Patents. Accessed on 8 October 2013, fromhttp://www.ipophil.gov.ph/index.php/patents.

Intellectual Property Office of the United Kingdom. (2013). The Research and Bolar Exception:Proposals to exempt clinical and field trials using innovative drugs from patent

infringement.International Pharmaceutical Privacy Consortium, 6 March 2012.

Lovells, H. (2010). Spanish Supreme Court rules on Bolar and experimental research exemption.Accessed on 8 October from http://www.lexology.com/library/detail.aspx?g=20f5c6aa-

fa61-47d1-b680-d632f76110ce.Manthan, J. (2008). Patents Regime in India: Issues, challenges and opportunities in

Pharmaceutical Sector. Vol. 7, Issue 1, Journal of Third World Medicine.Novartis. (2011). Safe Harbor Exemption (Bolar Provision).

Ocampo, S. (2012). Cheaper medicines law hasn't served the poor. Accessed on 9 October 2013,from http://www.philstar.com/opinion/2012-06-09/815179/cheaper-medicines-law-hasnt-

served-poor.Picazo, O.Review of the Cheaper Medicines Program of the Philippines. Philippine Institute for

Development Studies.World Trade Organization. (2006). TRIPS Pharmaceutical Patents Obligations and Exceptions.

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