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FOURTEENTH CONGRESS OF THE 
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REPUBLIC OF THE PHILIPPINES 
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First Regular Session 
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S E N A T E  
S. No. 
10.2 
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INTRODUCED BY THE HONORABLE MAR R O U S  
EXPLANATORY NOTE 
This bill seeks to amend Republic Act No. 8293, otherwise known as the Intellectual 
Property Code of the Philippines, to protect public health by creating an environment that 
will lower the prices of medicines through increased competition among drug companies and 
by providing the government with better policy tools to significantly influence the supply 
and demand of medicines. 
In its report, the 13fh Congress’ Senate joint committees on trade and commerce and 
health and demography had noted Filipinos’ insufficient annual per capita health spending, 
of P1,979 as of 2004. A major part of this problem is the lack of access to affordable drugs and 
medicines. 
It was also found that the present intellectual property system has been used to great 
advantage by pharmaceutical industries in maximizing their profits, with 60% of the market 
dominated by muItinationals. Such dominance however is due to present laws that prevent a 
level playing field and that largely protect multinationals, who are holding practically all 
patents on pharmaceutical products as of 2005. 
As a general rule for developing countries, the fewer patents granted on medicines, 
the better, so that large businesses’ control over the industry is limited and generic versions 
can be introduced without delay. 
To further illustrate the lack of competitive prices in the country, we can compare 
local prices of branded medicines to their counterparts from abroad, specifically, from India 
and Pakistan. 
Norvasc, priced at P44.75 in the Philippines, sells for the equivalent of P5.00 in India. 
Bactrim 400, priced at P17.75 per tablet in the Philippines, sells for the equivalent of P1 in 
Pakistan, and P0.69 in India. 
The flaws of the present Intellectual Property Code of the Philippines have resulted 
in a significant imbalance between supply and demand of drugs and medicines. More 
specifically, the market dominance of multinationals has caused artificial barriers to the fair 
trade of drugs and medicines which has led to high prices and lack of access to drugs and 
medicines to the detriment of millions of Filipinos. 


This bill is in line with the Agreement on Trade-Related Aspects of Intellectual 
Property Rights (TRIPS) and the Doha Declaration on the TRIPS Agreement and Public 
Health of the World Trade Organization. It provides the flexibilities allowed to developing 
countries under the two accords. 
The proposed amendments to the Intellectual Property Code will allow generic .drug 
manufacturers to begin experimentation, production and registration on patented drugs or 
medicines even prior to the expiration of the patents. As per industry estimates and 
experience, under the present law, generic drug makers take roughly three years after a 
patent expires in order to study the patented drug. This results in a virtual patent extension 
of three years, a period wherein patent holders can continue to charge high prices for their 
medicines. 
Through the early working doctrine, generics companies will be able to make 
available their products immediately after expiration of the drug patent, thus preventing a 
continued monopoly on prices by the patent holder. This doctrine has already led to a 
significant reduction of prices in the USA, Japan, Canada, Israel and Thailand. 
Furthermore, the proposed measure will bar patent owners from extending patents on 
the basis of a ‘hew use” for existing substances. The practice of extending patents on such 
grounds has allowed patent owners to continue a hold on the patent, even when the new use 
does not result in a new product or could even be deemed an “obvious” use. 
The bill will also provide a legal mechanism for the importation of drugs whose 
patents have not expired locally. Parallel importation, as it is called, is already in practice 
among European Union nations, as well as in Japan, Argentina, Cambodia, Thailand and 
Vietnam. The changes to the law will also provide for the use of local trademarks of patented 
drugs in an importation scheme. 
Lastly, the bill grants the government discretion in use of patents when public health 
is at stake, and provides a framework for ample compensation to the patent holder. 
The bill has been discussed extensively in the 13th Congress, but was not passed, to the 
dismay of stakeholders and the general public in need of more affordable medicines. It is 
high time that Congress enacts this bill into law during the 14th 
Congress. 
In view of the foregoing, approval of this bill is earnestly requested. 


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FOURTEENTH CONGRESS OF THE 
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REPUBLIC OF THE PHILIPPINES 
1 
First Regular Session 
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INTRODUCED BY THE HONORABLE MAR ROXAS 
AN ACT 
TO MAKE THE LAWS ON PATENTS, TRADENAMES AND TRADEMARKS MORE 
RESPONSIVE TO THE HEALTH CARE NEEDS OF THE FILIPINO PEOPLE BY 
CLARIFYING NON-PATENTABLE INVENTIONS, ALLOWING THE IMPORTATION 
AND EARLY DEVELOPMENT OF PATENTED MEDICINES, AND MODIFYING 
AND INCREASE ACCESS TO AND SUPPLY OF QUALITY DRUGS OR MEDICINES, 
AMENDING FOR THIS PURPOSE CERTAIN PROVISIONS OF REPUBLIC ACT NO. 8293 
OTHERWISE KNOWN AS THE INTELLECTUAL PROPERTY CODE OF THE 
PHILIPPINES. 
GOVERNMENT USE PROVISIONS FOR DRUGS OR MEDICINES, TO LOWER PRICES 
Be it enacted by the Senate and House of Representatives of the Philjpines in Congress 
assem bled: 
SECTION 1. Section 26 of Republic Act No. 8293 is hereby amended to-read as follows: 
“SEC. 26. Inventive Step. - 26.1. An invention involves an inventive 
step if, having regard to prior art, it is not obvious to a person skilled in the 
art at the time of the filing date or priority date of the application claiming 
the invention. 
“26.2. THERE IS NO INVENTIVE STEP IF THE INVENTION 
RESULTS FROM THE MERE DISCOVERY OF A NEW FORM OR NEW 
PROPERTY OF A KNOWN SUBSTANCE WHICH DOES NOT RESULT 
IN THE ENHANCEMENT OF THE KNOWN EFFICACY OF THAT 
SUBSTANCE, OR, THE MERE DISCOVERY OF ANY NEW USE FOR A 
KNOWN SUBSTANCE OR A KNOWN PROCESS UNLESS SUCH 


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KNOWN PROCESS RESULTS IN A NEW PRODUCT THAT EMPLOYS 
AT LEAST ONE NEW REACTANT.” 
SEC. 2. Section 72 of Republic Act No. 8293 is hereby amended to read as follows: 
“SEC. 72. Limitations ofpatent 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 OR 
MEDICINES, THE LIMITATION ON PATENT RIGHTS TO THE USE, 
SALE, OFFERING FOR SALE OR IMPORTATION OF THE PRODUCT 
SHALL APPLY AFTER A DRUG OR MEDICINE HAS BEEN 
INTRODUCED ANYWHERE IN THE WORLD BY THE PATENT 
OWNER, OR BY ANY PARTY AUTHORIZED TO USE THE 
INVENTION. 
“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 [the 
purpose of experiments that relate to the subject matter of the patented 
invention;] EXPERIMENTAL USE OF THE INVENTION FOR 
SCIENTIFIC PURPOSES OR EDUCATIONAL PURPOSES AND SUCH 
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OTHER ACTIVITIES DIRECTLY RELATED TO SUCH SCIENTIFIC OR 
EDUCATIONAL EXPERIMENTAL USE. 
“72.4. 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 
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 
TRIPS AGREEMENT, THE INTELLECTUAL PROPERTY OFFICE (IPO), 
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 ENACTMENT OF THIS LAW. 
“[72.4] 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 prescription or acts concerning the medicine so 
prepared; 
“[72.5] 72.6. Where the invention is used in any ship, vessel, aircraft, 
or land vehicle of any other country entering the territory of the 
Philippines temporarily or accidentally: Provided, That such invention is 
used exclusively for the needs of the ship, vessel, aircraft, or land vehicle 
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and not used for the manufacturing of anything to be sold within the 
Philippines. (Secs. 38 and 39, R.A. No. 165a)” 
SEC. 3. Section 74 of Republic Act No. 8293 is hereby amended to read as follows: 
“SEC. 74. Use of Invention by Government. - 74.1. A Government 
agency or third person authorized by the Government may exploit the 
invention even without agreement of the patent owner where: 
(a) The public interest, in particular, national security, nutrition, 
health or the development of other sectors, as determined by 
the appropriate agency of the government, so requires; or 
(b) A judicial or administrative body has determined that the 
manner of exploitation, by the owner of the patent or his 
license, is anti-competitive; OR 
(C) THERE IS PUBLIC NON-COMMERCIAL USE OF THE 
PATENT BY THE PATENTEE, WITHOUT SATISFACTORY 
REASON. 
“74.2. UNLESS OTHERWISE PROVIDED HEREIN, [Tlthe use by the 
Government, or third person authorized by the Government shall be 
subject, [mutatis mutandis, to the conditions set forth in Sections 95 to 97 
and 100 to 102. (Sec. 41, R.A. No. 165a)I TO THE FOLLOWING 
PROVISIONS: 
(A) IN SITUATIONS OF 
NATIONAL 
EMERGENCY 
OR 
OTHER CIRCUMSTANCES OF EXTREME URGENCY, THE 
RIGHT HOLDER SHALL BE NOTIFIED AS SOON AS 
REASONABLY PRACTICABLE; 
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(B) 
IN THE CASE OF PUBLIC NON-COMMERCIAL USE, 
WHERE 
THE 
GOVERNMENT 
OR 
CONTRACTOR, 
WITHOUT MAKING A PATENT SEARCH, KNOWS OR 
HAS DEMONSTRABLE GROUNDS TO KNOW THAT A 
VALID PATENT IS OR WILL BE USED BY OR FOR THE 
GOVERNMENT, THE 
RIGHT 
HOLDER 
SHALL 
BE 
INFORMED PROMPTLY; 
(C) 
THE SCOPE AND DURATION OF SUCH USE SHALL BE 
LIMITED TO THE PURPOSE FOR WHICH IT WAS 
AUTHORIZED, AND IN THE CASE OF SEMI-CONDUCTOR 
TECHNOLOGY, SHALL ONLY BE FOR PUBLIC NON- 
COMMERCIAL USE OR TO REMEDY A PRACTICE 
DETERMINED AFTER JUDICIAL OR ADMINISTRATIVE 
PROCESS TO BE ANTI-COMPETITIVE; 
(D) 
(E) THE RIGHT HOLDER SHALL BE PAID ADEQUATE 
REMUNERATION IN THE CIRCUMSTANCES OF EACH 
CASE, TAKING INTO ACCOUNT THE ECONOMIC VALUE 
OF THE AUTHORIZATION; 
THE LEGAL VALIDITY OF ANY DECISION RELATING 
TO THE AUTHORIZATION OF SUCH USE SHALL BE 
SUBJECT TO JUDICIAL REVIEW AND 
SUCH USE SHALL BE NON-EXCLUSIVE; 
(F) 
(G) THE 
USE 
OR 
OTHER EXPLOITATION BY THE 
GOVERNMENT OR THIRD PERSON AUTHORIZED BY 
THE GOVERNMENT OF DRUGS OR MEDICINES UNDER 
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THIS SECTION SHALL BE SUBJECT TO THE EXCLUSIVE 
DETERMINATION OF 
THE 
PRESIDENT 
OF 
THE 
REPUBLIC OF THE PHILIPPINES AND SHALL BE 
IMMEDIATELY EXECUTORY: PROVIDED, THAT NO 
COURT, EXCEPT THE SUPREME COURT OF THE 
PHILIPPINES, 
SHALL 
ISSUE 
ANY 
TEMPORARY 
RESTRAINING ORDER OR PRELIMINARY INJUNCTION 
OR PRELIMINARY MANDATORY INJUNCTION THAT 
WILL PREVENT ITS IMMEDIATE EXECUTION. THE 
OFFICE OF THE PRESIDENT, IN CONSULTATION WITH 
THE APPROPRIATE GOVERNMENT AGENCIES, SHALL 
ISSUE THE APPROPRIATE IMPLEMENTING RULES AND 
REGULATIONS FOR THE EXERCISE OF THIS AUTHORITY 
WITHIN ONE HUNDRED TWENTY (120) DAYS AFTER 
ENACTMENT OF THIS LAW. ALL CASES ARISING FROM 
THE IMPLEMENTATION OF THIS PROVISION SHALL BE 
COGNIZABLE 
BY 
COURTS 
WITH 
APPROPRIATE 
JURISDICTION PROVIDED BY LAW.” 
SEC. 4. Section 159 of Republic Act No. 8293 is hereby amended to read as follows: 
“x x x 
(x 
x x 
‘x x x 
‘(x 
x x 
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"159.4 THERE SHALL BE NO INFRINGEMENT OF TRADEMARKS 
OR TRADENAMES OF IMPORTED OR SOLD DRUGS OR MEDICINES 
ALLOWED UNDER SECTION 72.1: PROVIDED, THAT SAID DRUGS OR 
MEDICINES BEAR THE REGISTERED MARKS THAT HAVE NOT BEEN 
TAMPERED, MODIFIED, OR INFRINGED UPON AS DEFINED UNDER 
SECTION 155 OF THIS CODE." 
SEC. 5. Implementing Rules and Regulations. -Unless otherwise provided herein, the 
Intellectual Property Office shall issue the necessary implementing rules and regulations 
within one hundred twenty (120) days after enactment of this law. 
SEC. 6. Separability Clause. - Any portion or provisions of this Act that may be 
declared unconstitutional or invalid shall not have the effect of nullifying other portions and 
provisions hereof as long as such remaining portion or provision can still subsist and be given 
effect in their entirety. 
SEC. 7. Repealing Clause. - All laws, decrees, executive orders, proclamations and 
administrative regulations, or parts thereof inconsistent herewith are hereby repealed or 
modified accordingly. 
SEC. 8. Effectivity Clause. - This Act shall take effect fifteen (15) days after its 
publication in at least two national papers of general circulation. 
Approved,