THIRTEENTH CONGRESS OF THE 
1 
5 0g-i '1 3 <':, J. :i 5 
REPUBLIC OF THE PHILIPPINES 
) 
Second Regular Session 
1 
~~~~~~~~~~~1 
BY : 
IIcp--,-- c 
S E N A T E  21139 
INTRODUCED BY HONORABLE MAR ROXAS 
EXPLANATORY NOTE 
This bill will amend Republic Act No. 8293, otherwise known as The Intellectual 
Property Code ofthe Philippirzes, to protect public health by creating an environment that 
will lower the prices of medicines through greater competition among drug companies 
and by providing the government with better policy tools to significantly influence the 
supply and demand of medicines. 
It seeks to do so through the early working doctrine in the experimentation, 
production and registration of patented drugs or medicines and its appurtenant data prior 
to the expiration of patents. Industry data shows that it takes a local manufacturer around 
two years to study, experiment, register, manufacture and distribute in commercial 
quantities. 
This amendment will allow generics manufacturers to commence 
manufacturing, distribution and sale to the public immediately after patent expiration. 
This is based on the Bolar exception, which led to significant reductions in the prices of 
medicines upon adoption in the USA, Japan, Canada, Israel and Thailand. 
Corollary to this, the bill also considers new uses, molecules or compounds of a 
patented invention like drugs or medicines as part of the original patent. Hence, new 
patents cannot be applied for previously patented drugs or processes to cover newly 
discovered benefits. This will prevent patented products or processes from doubling or 
prolonging its protected period or monopoly position in the market. 
Further, this bill will also provide the government with better policy tools to 
protect public health by establishing a clear and legally secure framework for parallel 
importation and more liberal compulsory licensing procedures with regard to medicines. 
The changes will recognize the doctrine of international exhaustion as provided in Article 
6 of the TRIPS Agreement so that patented drugs or medicines which the country needs 
may be imported. It will ako establish an exception to the application of standard 
compulsory licensing requirements in the importation, including parallel importation, or 
manufacturing or sale or distribution by the government of medicines to protect public 
health based on a coordinated determination by the Secretaries of the DOH and DTI. 
Lastly, this bill will provide a limited exception in the use of tradenames and/or 
trademarks to protect public health for cases involving government procured medicines. 
This bill also provides legal protection for government officials involved in 
parallel importations from all kinds of harassment suits. 
It also shields parallel 
importations from temporary restraining orders or injunctions. Lastly, this bill vests 
original and exclusive jurisdiction to the Intellectual Property Office (IPO) over cases 
involving parallel importation or issuance of compulsory licenses for drugs or medicines. 
Various studies conducted by the Department of Trade and Industry, concerned 
non-governmental organizations (NGOs) and pharmaceutical groups have shown that 
drug spending in the Philippines is astonishingly among the highest in Southeast Asia. 
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Based on recent price surveys done by the Philippine International Trading 
Corporation (PITC), an agency originally attached to the Department of Trade and 
Industry but recently transferred to the Office of the President (OP), the savings 
generated through the Presyung Tama Program done through parallel importation is 
highlighted in the following comparative prices for major drugs: 
Generic Name 
Drug/Dosage 
Domestic / 
PITC 
Private 
Maximum 
Savings 
Drug Store 
Retail Price 
Price 
(As of 
Under the present state of our law, patent owners oppose parallel importation 
citing Sec. 71 of the Intellectual Property Code (IPC), which secures to the patentee the 
right to exclude anyone from making, using, selling or importing patented products. 
Aside from that, Section 95 of the IPC on compulsoly licensing provides very restrictive 
rules on compulsory licensing. Furthermore, in Section 101 of the IPC, the patentee may 
move for the cancellation of the compulsory licenses upon showing of new facts and 
circumstances justifying such action. Lastly, patent owners argue that parallel importation 
violates the tradename and trademark protection clause in the IPC. 
It should be noted that the exercise of the patentee’s exclusive rights is subject to 
and must be correlated with the public interest exceptions under Section 74 in favor of 
the Government or any third person authorized by the Government in the circumstances 
enumerated thereunder. The public interest consideration under Section 74, particularly 
as the same relates to public health, is of primordial importance especially as this echoes 
the constitutional mandate for the State to protect the health of the people (Sec. 15, Art. 
ZI, 1987 Constitutiun) and to adopt an integrated and comprehensive approach to health 
development which shall endeavor to make essential goods, health and other social 
services available to all the people at affordable cost (Sec. 11, Art. XZZZ, ibid.). 
It is a sad state of affairs that the exorbitant cost of medicines puts them beyond 
the reach of the marginalized Filipino despite the major advances in pharmaceutical 
research and development. Clearly, it is not the lack of cure or medicines but the 
unaffordability thereof that causes one to succumb to death due to illness. The passage of 
this bill will correct this situation. 
In view of the foregoing, approval of this bill is ear 
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. ,  
THIRTEENTH CONGRESS OF 
1 
THE REPUBLIC OF THE PHILIPPINES 
1 
5 OCI ’I3 
- 
Second Regular Session 
1 
INTRODUCED BY 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 ALLOWING THE IMPORTATION, EARLY 
DEVELOPMENT OF PATENTED MEDICINES AND EXCEPTIONS TO THE 
APPLICATION 
OF 
STANDARD 
COMPULSORY 
LICENSING 
REQUIREMENTS FOR DRUGS OR MEDICINES TO LOWER DRUG OR 
MEDICINE PRICES BY AMENDING FOR THIS PURPOSE CERTAIN 
PROVISIONS OF REPUBLIC ACT NO. 8293 OTHERWISE KNOWN AS THE 
INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress Assembled: 
Section 1. Sec.21 of Republic Act No. 8293 is hereby amended to read as 
follows: 
“Sec.21. Patentable Inventions. - Any technical solution of a problem in 
any field of human activity which is new, involves an inventive step and is industrially 
applicable shall be patentable. It may be, or may relate to, a product, or process, or an 
improvement of any of the foregoing. NEW USES OR MOLECULES OR 
COMPOUNDS OF A PATENTED INVENTION SHALL BE DEEMED AS 
INCLUDED IN THE ORIGINAL PATENT AND SHALL NOT BE ALLOWED TO BE 
COVERED BY A NEW AND SEPARATE PATENT.” 
Section 2. Sec.72 of Republic Act No. 8293 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 OR 
MEDICINES, THE LIMITATION ON PATENT RIGHTS 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 
purpose: Provided, that it does not significantly prejudice the economic 
interests of the owner of the patent; 
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72.3. Where the act consists of making or using exclusively for 
EXPERIMENTAL USE OF THE INVENTION FOR SCIENTIFIC 
PURPOSES OR FOR COMMERCIAL PURPOSES THAT DO NOT 
UNREASONABLY CONFLICT WITH A NORMAL EXPLOITATION 
OF THE PATENT AND THAT DO NOT UNREASONABLY 
PREJUDICE THE LEGITIMATE INTERESTS OF THE PATENT 
OWNER, TAKING INTO ACCOUNT THE LEGITIMATE INTERESTS 
OF SUCH THIRD PARTIES. 
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 
REQUIRED 
UNDER 
ANY 
LAW 
OF 
THE 
PHILIPPINES OR OF ANOTHER COUNTRY THAT REGULATES 
THE MANUFACTURE, CONSTRUCTION, USE OR SALE OF ANY 
PRODUCT. 
72.5 [72.4]. 
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; 
72.6 [72.5]. Where the invention is used in any ship, vessel, 
aircraft, or land vehicles 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 
and not used for the manufacturing of anything to be sold within the 
Philippines.” 
Section 3. Sec.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. 
74.2. Unless otherwise provided herein, the 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. 
74.3. 
SUBJECT TO THE CONTROL, SUPERVISION AND 
DETERMINATION OF THE RESPECTIVE SECRETARIES OF THE 
DEPARTMENT OF HEALTH AND DEPARTMENT OF TRADE AND 
INDUSTRY, 
THE 
IMPORTATION, 
INCLUDING 
PARALLEL 
IMPORTATION, 
OR 
MANUFACTURING 
OR 
SALE 
OR 
DISTRIBUTION BY THE GOVERNMENT OR ANY OF ITS 
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AUTHORIZED REPRESENTATIVES OF DRUGS OR MEDICINES TO 
PROTECT 
PUBLIC 
HEALTH 
SHALL 
BE 
IMMEDIATELY 
EXECUTORY ONLY UPON FILING OF AN EX PARTE NOTICE 
BEFORE THE INTELLECTUAL PROPERTY OFFICE (IPO). THIS 
PROCEDURE SHALL BE AN EXCEPTION TO THE APPLICATION 
OF 
THE 
STANDARD REQUIREMENTS 
OF 
COMPULSORY 
LICENSING. ANY 
DRUG 
OR MEDICINE 
PROCURED, 
AS 
PROVIDED HEREIN, SHALL BE EVALUATED AND APPROVED 
FOR PUBLIC CONSUMPTION BY THE BUREAU OF FOOD AND 
DRUGS (BFAD) AFTER PROPER LABORATORY TESTING FOR 
SAFETY, EFFICACY AND QUALITY. IT IS PROVIDED FURTHER, 
THAT THE SALE AND DISTRIBUTION OF SUCH DRUGS OR 
MEDICINES SHALL ONLY BE MADE BY PERSONS WHO ARE 
DULY LICENSED BY BOTH THE DEPARTMENT OF HEALTH TO 
ENGAGE IN THE SALE AND DISTRIBUTION OF DRUGS OR 
MEDICINES AND AUTHORIZED BY THE DEPARTMENT OF 
TRADE AND INDUSTRY TO BE OFFICIAL DISTRIBUTORS OR 
RETAILERS OF THE DRUGS OR MEDICINES SUBJECT OF THE 
SAID PROCUREMENT. 
ALL 
IMPORTATIONS, MANUFACTURING, 
SALE 
OR 
DISTRIBUTION 
OF 
DRUGS 
OR 
MEDICINES 
SHALL 
BE 
UNDERTAKEN BY THE GOVERNMENT OR ANY OF ITS 
AUTHORIZED 
REPRESENATIVES 
THROUGH 
THE 
COORDINATED REGULATORY EFFORTS AND SUBJECT TO THE 
APPROVAL OF THE DEPARTMENTS OF HEALTH AND TRADE 
AND INDUSTRY. 
THE 
IMPORTATION, 
MANUFACTURING, 
SALE 
OR 
DISTRIBUTION OF DRUGS OR MEDICINES UNDER THIS 
PROVISION SHALL NOT BE SUBJECT TO ANY TEMPORARY 
RESTRAINING ORDER OR INJUNCTION AND NO SUIT OF ANY 
KIND RELATED TO SUCH MAY BE FILED AGAINST THE 
RELEVANT PUBLIC OFFICIALS OR OTHER PERSONS ACTING 
UNDER THE DIRECTION OF THE SECRETARIES OF THE 
DEPARTMENT OF HEALTH AND THE DEPARTMENT OF TRADE 
AND INDUSTRY FOR ANYTHING WHICH IS IN GOOD FAITH 
DONE OR INTENDED TO BE DONE IN THE EXECUTION OR 
PURPORTED EXECUTION OF THIS PROVISION. 
THE DEPARTMENT OF HEALTH AND THE DEPARTMENT 
OF TRADE AND INDUSTRY SHALL ACCORDINGLY INDEMNIFY 
ITS 
MEMBERS 
AND 
OTHER 
OFFICIALS, 
INCLUDING 
PERSONNEL OF THE DEPARTMENTS PERFORMING ANY 
FUNCTION OR SERVICE RELATED TO THIS PROVISION 
AGAINST ALL COSTS AND EXPENSES REASONABLY INCURRED 
BY SUCH PERSONS IN CONNECTION WITH ANY CIVIL OR 
CRIMINAL ACTION, SUIT OR PROCEEDINGS TO WHICH HE MAY 
BE, OR IS MADE A PARTY BY REASON OF THE PERFORMANCE 
OF HIS FUNCTIONS OR DUTIES, UNLESS HE IS FINALLY 
ADJUDGED IN SUCH ACTION OR PROCEEDING TO BE LIABLE 
FOR NEGLIGENCE OR MISCONDUCT. 
THE INTELLECTUAL PROPERTY OFFICE (IPO) SHALL 
HAVE ORIGINAL AND EXCLUSIVE JURISDICTION OF ALL 
CASES 
FOR 
THE 
IMPORTATION 
OR 
ISSUANCE 
OF 
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COMPULSORY LICENSES OF DRUGS OR MEDICINES AS 
DESCRIBED HEREIN. ALL CASES DECIDED UPON BY THE 
INTELLECTUAL PROPERTY OFFICE (IPO) WITH FINALITY 
SHALL BE APPEALABLE TO THE COURT OF APPEALS. THE 
INTELLECTUAL PROPERTY OFFICE SHALL ALLOW ONLY ONE 
MOTION FOR RECONSIDERATION OF ITS DECISION. 
PARALLEL 
IMPORTATION 
SHALL REFER 
TO 
THE 
IMPORTATION AND RESALE OF DRUGS OR MEDICINES IN THE 
PHILIPPINES, WHETHER PATENTED OR NOT AND WITHOUT 
THE 
CONSENT 
OF 
THE 
PATENT 
HOLDER, 
BY 
THE 
GOVERNMENT 
OR 
ANY 
OF 
ITS 
AUTHORIZED 
REPRESENTATIVES BASED UPON THE JOINT DETERMINATION 
OF THE SECRETARIES OF THE DEPARTMENT OF HEALTH AND 
THE DEPARTMENT OF TRADE AND INDUSTRY FOR THE 
PURPOSE OF PROTECTING PUBLIC HEALTH. 
DRUGS AND 
MEDICWES APPROVED AND IMPORTED FOR THIS PURPOSE 
SHALL NOT BE CONSIDERED AS COUNTERFEIT DRUGS AS 
DEFINED BY APPLICABLE LAWS.” 
Section 4. Sec.166 of Republic Act No. 8293 is hereby amended to read as 
follows: 
“Sec. 166. Goods Bearing Infringing Marks or Tradenames. - 
166.1. UNLESS OTHERWISE PROVIDED, no article of imported 
merchandise which shall copy or simulate the name of any domestic 
product, or manufacturer, or dealer, or which shall copy or simulate a 
mark registered in accordance with the provisions of this Act, or shall bear 
a mark or trade name calculated to induce the public to believe that the 
article is manufactured in the Philippines, or that it is manufactured in any 
foreign country or locality other than the country or locality where it is in 
fact manufactured, shall be admitted to entry at any customhouse of the 
Philippines. 
166.2. THE IMPORTATION, MANUFACTURING, SALE OR 
DISTRIBUTION 
BY 
THE 
GOVERNMENT OF 
DRUGS 
OR 
MEDICINES WITH TRADEMARKS AND TRADENAMES FOR THE 
PROTECTION OF PUBLIC HEALTH AS PROVIDED IN SECTION 
74.3 OF THIS ACT SHALL BE A LIMITED EXCEPTION TO THE 
RIGHTS 
CONFERRED 
BY 
TRADEMARKS 
AND/OR 
TRADENAMES; PROVIDED FURTHER, THAT SUCH DRUGS OR 
MEDICINES PROCURED BY ?“E GOVERNMENT OR ANY OF ITS 
AUTHORIZED REPRESENTATIVES UNDER THIS PROVISION 
SHALL NOT BE SUBJECT TO ANY TEMPORARY RESTRAINING 
ORDER OR INJUNCTION AND NO SUIT OF ANY KIND RELATED 
TO SUCH MAY BE FILED AGAINST THE RELEVANT PUBLIC 
OFFICIALS 
OR 
OTHER 
PERSONS ACTING 
UNDER 
THE 
DIRECTION OF THE SECRETARIES OF THE DEPARTMENT OF 
HEALTH AND THE DEPARTMENT OF TRADE AND INDUSTRY 
FOR ANYTHING WHICH IS IN GOOD FAITH DONE OR INTENDED 
TO BE DONE IN THE EXECUTION OR PURPORTED EXECUTION 
OF THIS PROVISION. 
THE DEPARTMENT OF HEALTH AND THE DEPARTMENT 
OF TRADE AND INDUSTRY SHALL ACCORDINGLY INDEMNIFY 
ITS 
MEMBERS 
AND 
OTHER 
OFFICIALS, 
INCLUDNG 
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PERSONNEL OF THE DEPARTMENTS PERFORMING ANY 
FUNCTION OR SERVICE RELATED TO THIS PROVISION 
AGAINST ALL COSTS AND EXPENSES REASONABLY INCURRED 
BY SUCH PERSONS IN CONNECTION WITH ANY CIVIL OR 
CRIMINAL ACTION, SUIT OR PROCEEDINGS TO WHICH HE MAY 
BE, OR IS MADE A PARTY BY REASON OF THE PERFORMANCE 
OF HIS FUNCTIONS OR DUTIES, UNLESS HE IS FINALLY 
ADJUDGED IN SUCH ACTION OR PROCEEDING TO BE LIABLE 
FOR NEGLIGENCE OR MISCONDUCT. 
THE INTELLECTUAL PROPERTY OFFICE (IPO) SHALL 
HAVE ORIGINAL AND EXCLUSIVE JURISDICTION OF ALL 
TRADEMARK AND TRADENAMES CASES INVOLVING THE 
IMPORTATION OR ISSUANCE OF COMPULSORY LICENSES OF 
DRUGS OR MEDICINES AS DESCRIBED HEREIN. ALL CASES 
DECIDED UPON BY THE INTELLECTUAL PROPERTY OFFICE 
(IPO) WITH FINALITY SHALL BE APPEALABLE TO THE COURT 
OF APPEALS. THE INTELLECTUAL PROPERTY OFFICE SHALL 
ALLOW ONLY ONE MOTION FOR RECONSIDERATION OF ITS 
DECISION.” 
166.3. In order to aide the officers of the customs service in 
enforcing this prohibition, any person who is entitled to the benefits of this 
Act, may require that his name and residence, and the name of the locality 
in which his goods are manufactured, a copy of the certificate of 
registration of his mark or trade name, to be recorded in books which shall 
be kept for this purpose in the Bureau of Customs, under such regulations 
as the Collector of Customs with the approval of the Secretary of Finance 
shall prescribe, and may furnish to the said Bureau facsimiles of his name, 
the name of the locality in which his goods are manufactured, or his 
registered mark or trade name, and thereupon the Collector of Customs 
shall cause one (1) or more copies of the same to be transmitted to each 
collector or to other proper officers of the Bureau of Customs.” 
Section 5. 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. 
Section 6. Repealing Clause. - All laws, decrees, executive orders, proclamations 
and administrative regulations, or parts or parts thereof inconsistent herewith are hereby 
repealed or modified accordingly. 
Section 7. Effectivity Clause. -This Act shall take effect fifteen (15) days after 
its publication in at least two (2) national papers of general circulation. 
Approved. 
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