NGOs’ Submit Technical Review of the DOH and IPO Draft IRR

Posted on January 26, 2009. Filed under: Resources |

Ayos na Gamot sa Abot-Kayang Presyo, together with the other Civil Society Groups, made a technical review of the draft implementing rules and regulations made by the Department of Health and the Intellectual Property Office. Said reviews were submitted to the named government agencies.
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Technical Review of the Draft Implementing Rules and Regulations
(IRR) of Republic Act 9502

SUMMARY OF RECOMMENDATIONS

This is a joint submission to the Intellectual Property Office by different international and local civil
society groups- Ayos na Gamot sa Abot Kayang Presyo, Cancer Warriors Foundation, Cut the Cost
Cut the Pain Network, OXFAM and Third World Network.

The technical review focused on Chapter 2 of Republic Act 9502, and is based on the draft IRR
presented by the Intellectual Property Office, and cross-referenced with the draft IRR of the
Department of Health. The group’s technical review on the draft IRR of the Department of Health is
found in a separate paper.

Below are 28 key recommendations by different civil society organizations seeking to ensure that
public health always takes precedence over intellectual property rules. This means that the IRR
must enable the Government to broadly use public health flexibilities under TRIPS without any
impediment to safeguard and promote public health. In particular, the government – through its
implementing agencies – or the Intellectual Property Office and the Department of Health, should
have the ability to use safeguards to ensure generic medicines can enter the market immediately
upon patent expiration, to ensure that governments can override patent protection to introduce
inexpensive versions of medicines to protect public health, or to import a patented product
marketed in another country at a lower price (parallel importation).

Rules on Construction
1. We recommend to retain the law’s provision on Construction and not add any modifications as
shown in the draft IRR of the IPO. (A1)

2. We recommend adopting the version of the Department of Health’s draft of the IRR where it
retained the law’s Declaration of policy and Construction provisions. (A1)

Rules on Non-Patentable Inventions and Inventive Step

3. We recommend that the DOH should determine the efficacy of medicines and this should bind
the patent examiner in deciding to grant a patent. (B1)

4. The proposed rule requiring IPO to defer to the decision of DOH on determination of significant
efficacy is only applicable to patent applications for known substances, processes, and any other
derivatives of the known substance.

5. We recommend the deletion of the three new provisions on efficacy under (Roman Numbers 2-
4, under the Rule on Inventive Step. Refer to Draft IRR, page 3. (C1)

6. Efficacy should be defined in relation to its therapeutic effect on the body. (C2)

7. We propose that the guideline in determining efficacy should include the following:
a) Determine the efficacy of patent applications with regard to its healing and therapeutic effect
on the body e.g., including its side-effects and long-term effects;
b) The determination of efficacy shall be made on a case-by-case basis with a ‘statistically
significant sample’ of the population that will be using such drug or medicine
c) It should always be done in comparison with all existing drugs of the same therapeutic
category or sub-category available to the public at the time of the patent application.
d) Submission of related comparative test results should be a requirement. This should also
include an independently verifiable study to establish the credibility and integrity of the
patent applicant’s results of clinical trials.

8. In relation to the law’s provision on the determination of efficacy, and to make the rules
consistent with the proposal to have a credible expertise and authority – such as the Department
of Health, to asses efficacy, we find it necessary to amend the rules pertaining to prior art and a
person skilled in the art when it comes to drugs and medicines. (C5) Particularly, we recommend
the following rules:
a. That a person skilled in the art under this Rule, in the case of drugs and medicines, shall
have a doctorate and post-doctorate degree in the sub-field or sub-area of the drug or
medicine covered by the patent application.
b. That prior art under this rule shall also consider unity of invention and mosaicing, which
refers to the combining of documents to establish the lack of inventive step of the patent
application.

9. Reinstate the phrase “any new property or” that may have been inadvertently deleted. Refer
to Page 2, Draft IRR, Rule [ ]: Non-Patentable Inventions, between the phrase “or the mere
discovery of” and “new use for a known substance….” (B3)

10. Reinstate the word “new” that may have been inadvertently deleted. Refer to Page 3, Draft IRR
Rule [ ]: Inventive Step, between “or the mere discovery of any” and “property or new use for a
known substance, ….” (C7)

Rules on Introduction of the Patent Exhaustion
11. We recommend deleting the following words “donation, promotion, advertising, medical
prescription or” as one of the ways of introducing a product in relation to international
exhaustion principle, as shown below. (D1)

12. We propose that the following guidelines and procedures on the conduct of parallel importation
be reflected in the IRR. (D2)
(a) That government purchases should be done through the PITC
(b) That third party or private sector parallel importations of drugs and medicines have the
option to course it through the PITC, other than directly importing on their own.
(c) The IRR draft of the Department of Health should specify that the retained income of BFAD
(as provided under Chapter 4 of RA9502) shall allocate a portion of it to support the
registration and testing of parallel imported drugs.
(d) Third parties should NO longer be required to undergo a separate and distinct accreditation
process nor secure any clearance from the IPO, other than the usual business registration at
BFAD.

Rules on Limitation of Rights to allow experimental use
13. We recommend adding criteria on determining what activities qualify as an experimental use for
scientific or educational purposes and other related activities, as this will allow clearer
implementation of the law, and will entice research and development activities. (E1)
Rules on Data Protection & Bolar Exception

14. We recommend deleting the whole rule on data protection and replace it with the exact text on
Article 39 of the TRIPS Agreement, since this is consistent with minimum standards under
TRIPS. (F1)

15. We also see the need to supplement Article 39 of the TRIPS Agreement with guidelines on a)
determining unfair commercial use, b) determining eligibility for data protection, and c) nature
of data protection. (F2)

16. We also note the need to state the primacy of public health interests over claims for data
protection. Patent holders may not claim data protection from unfair commercial use over public
health concerns. (F4)

17. We also note the need to explicitly state a procedure to guide pharmaceutical companies in
applying for the early working of patents, or the Bolar exception. The procedure on how to apply
early working of a patent must contain the following: (F5)
a. That the data sought to be protected from unfair commercial use should be disclosed to the
Bureau of Food and Drugs (BFAD).
b. That the data submitted by the originator may be used by the applicant for a generic
equivalent at anytime within the life of the patent.
c. That the process of using the data of the originator brand for the registration of a generic
equivalent at the drug regulatory agency (i.e., BFAD) is independent and separate from the
process of any petition invoking data protection that may arise and should be filed at the
Intellectual Property Office. As such, the registration process at BFAD shall continue unless
the IPO rule that it constitutes an unfair commercial use.

Rules on Government Use
18. We value the provision that exempts government use license from following the rules and
procedures prescribed for a compulsory license.

19. We recommend that all rules and procedures referring to a government use license should be
grouped under one section to allow easier understanding and facilitate better implementation.
(G1)

20.We recommend having explicit rules on the Scope and nature of the Supreme Court’s authority
to issue injunctions. (G2)

We only hope that the Supreme Court will issue specific rules that will define how
and when it will only intervene in these cases so that the public’s access to medicines will
not be impaired, and will only apply injunctive relief in extraordinary circumstances.

21. Reinstate the law’s provisions concerning judicial review, and the issuance of temporary
restraining orders (TROs) or injunctions.(G2)

22. We recommend having explicit rules on determining adequate compensation, and basis for
computing royalty rate. (G4)

The rate may be based on the 2001 UNDP Human Development Report recommendation
of a maximum royalty rate of 4% of the price of the generic product, or through a tiered
royalty method (TRM) where the royalty is based on 4% of the high-income country price,
adjusted for the relative income per capita of those facing the disease in the Philippines.

Rules on Compulsory License
23. We recommend having a provision clarifying who may petition for the three types of procedures
on compulsory license (including Special Compulsory license) provided in the IRR. (D1)

24.We propose that the periods set in processing petitions for a compulsory license on the ground
of national emergency or public interest, be made non-extendible to expedite the process of
approval for compulsory licenses. (D2)

25. We recommend deleting the requirement of identifying the number and date of issue of the
patent in the form and contents of the petition. (D3)

Rules on Special Compulsory License
26.We recommend embedding the whole text of the WTO decision in the IRR, since it appears that
document reference number WT/L641 appears to be an invalid or an unrecognizable document
in the WTO website. (I1)

27. We recommend adding a rule allowing any person or group to petition the Department of Health
and cause the latter (DOH) to review and recommend a special compulsory license, if found
meritorius. The decision to reject or recommend the petition should be settled within reasonable
time by the Department of Health.

Rules on Preserving Existing Rights
We strongly urge the Intellectual Property Office to delete this provision on preserving existing
rights as it will render the law useless in enforcing parallel importation, government use license,
Bolar exception on existing patents; and, equally important, is the opportunity to challenge existing
patents based on the new law.

FULL TEXT of the CSO Technical Submission:
On IPO IRR
On DOH IRR

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