Here is Joey's discussion. Posting this with his permission. It is a well-written, well-argued piece as always, which many people outside of MeTA would be interested to learn. My short comments and Joey's reply further below. A bit long, about four pages, enjoy.
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I came across the attached article entitled
“Pharmaceutical firms seek full implementation of generics law” in Philippine
Star last August 8th. It mentions a forum in Manila where three companies
called “for the government to strengthen the [Cheaper Medicines Act’s]
implementation to allow drug outlets to carry a variety of medicine brands,
including those sourced through parallel importation, and give choices to
consumers.” (emphasis supplied) The three companies were raided by the National
Bureau of Investigation agents for alleged “violation of infringement on patent
rights” (sic) and selling “illegal drugs”. They argue that since their drugs
have been registered with the FDA, they are “not illegal”.
As an IP & Health Law practitioner and an advocate of
the Cheaper Medicines Act, I feel compelled to comment on this news article.
(Disclosure: I have no involvement in this case. My only interest is to make
sure that the Cheaper Medicines Law is properly understood.)
1. I asked
around and learned that the drug molecule in this case is etoricoxib. This
medicine is indicated for “acute and chronic treatment of signs and symptoms of
osteoarthritis and rheumatoid arthritis; treatment of ankylosing spondylitis;
acute gouty arthritis and primary dysmenorrhea; relief of acute pain; moderate
to severe acute pots-op pain associated with dental surgery and abdominal
gynaecological surgery.” It comes in two strengths – 30 mg. and 60 mg. (MIMS,
135th Ed., 2013). It is marketed in the Philippines as Arcoxia® by Merck Sharp
& Dohme (MSD), who I believe is also the patent owner or at least
authorized by the latter.
2. The
etoricoxib molecule has a valid and subsisting patent in the Philippines. The
patent is on the molecule itself. It is therefore not a frivolous patent, which
the Cheaper Medicines Law (CML) prohibits.
3. Sec. 72 of
the CML amended the Intellectual Property Code of the Philippines to allow
parallel importation. The patent owner does not have the right to prevent third
parties from importing a drug or medicine that has been “introduced in the
Philippines or anywhere else in the world by the patent owner.” (emphasis
supplied) By inserting the phrase “anywhere else in the world”, the Philippines
adopted the “international exhaustion” principle, which means that if the
patent owner sells the patented product anywhere in the world (not just in the
Philippines), his patent rights over the patented product is exhausted. He
cannot subsequently prevent the buyer of the patented product from selling or
importing it into the Philippines. To illustrate, if patent owner X sells his
patented medicine to Company Y in Thailand and the latter sells the product to
Company Z in the Philippines, Company X cannot prevent Company Z from importing
and selling the patented medicine in the Philippines. Why? Because Company X
has exhausted its patent rights over the patented product when it first sold it
to Company Y in Thailand. Stated differently, a patent owner loses his patent
rights over a specific patented product the first time he sells the latter. It
is also called the “doctrine of first sale”. The policy rationale behind this
rule is that the patent owner has already recovered whatever economic benefits
he is entitled to as a patent owner when he first sells the product. In short,
kumita na siya when he made the first sale.
4. The article
mentions “parallel importation”. I do not know whether this is because the
three companies believe they are engaged in parallel importation. In parallel
importation, however, what may be imported is only the product of the patent
owner. This means one can only import Arcoxia® or any etoricoxib brand
manufactured or authorized by MSD. It is not parallel importation if one imports a generic etoricoxib because
it did not come from MSD. Again, under Sec. 72 of the CML only the product
placed in the market by the patent owner anywhere in the world can be parallel
imported into the Philippines. If one imports the generic equivalent of
Arcoxia®, this means it was not MSD who placed it in the market and MSD has not
derived economic benefit from it. It therefore patent infringement if you
import the generic etoricoxib into the Philippines. Hindi siya parallel
importation kapag generic equivalent ang inangkat.
5. The three
companies also argue that since they were able to secure Certificates of
Product Registration (CPR) from the FDA for their etoricoxib product, they are
free to sell the same in the Philippines. No, that is not true. They should
still have to make sure that they are not infringing upon the IP rights
(trademarks and patents) of others. The FDA has nothing to do with
patents. Patents are with the IPO. The
role of the FDA is simply to make sure that the medicines you will market in
the Philippines are safe, effective and of good quality. (This task is no joke
given the proliferation of substandard medicines in the world.) This is why the
CPRs issued by the FDA state that the CPR holder holds the FDA free and
harmless from any damage resulting from any trademark or patent infringement
suit against the CPR holder. This means that there is no linkage between drug
registration and patents. This is what public health advocates fought for
several years ago, which the then BFAD accepted. (Malaysia and Indonesia Drug
Regulatory Authorities followed suit.) Unfortunately, with their argument the
three companies are unwittingly arguing for patent linkage. (Offhand, I don’t
think they realize the implications of their argument.) In any case, for the
nth time, patent linkage is NOT required by the TRIPS Agreement. It is in fact
a TRIPS Plus provision, or one that it not required by the World Trade
Organization. The WTO Doha Declaration on TRIPS and Public Health itself (aside
from WHO) encourages developing
countries to exercise the public health flexibilities afforded by the TRIPS
Agreement. Removing any linkage between patents and drug registration is one of
those flexibilities. Kapag naman ibinalik pa natin ‘yan, tayo na ang may problema.
Sinabi na nga ng WTO that developing countries like us should make use of TRIPS
flexibilities to protect public health, eh.
