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Important notice for patent owners for pharmaceuticals in Mexico
Last September 19, 2003, President Fox administration amended the
Rules of the Industrial Property Law and of the Rules of Health Supplies (Reglamento de Insumos para la Salud).
New list of patented active ingredients
As you may know, one of the most usual problems in Mexico in connection
to patents on medicines has been the lack of communication between the Mexican Patent and Trademark Office (MPTO) and the Ministry of Health (MH).
The MH has authority to approve the manufacture, commercialization and
importation of medicines in Mexico. No pharmaceutical product can be sold in Mexico without the approval of the MH. In many cases, the MH has authorized products that infringe Mexican patents.
For years the MH argued that patent matters were completely out of its
jurisdiction, and if there were patent infringement problems, they should be addressed to the MPTO or the courts.
This circumstance created a contradictory situation, where a federal
government agency such as the MPTO was issuing patents on medicines, granting to the patentee the exclusive right to the use of the invention in Mexico, while the MH was authorizing the commercialization of products that may infringe a patent on a medicine.
On September 19, 2003, the federal government amended the Rules of the
Industrial Property Law and of the Rules of Health Supplies. The amended
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provisions stipulated, on one hand, that the MPTO has to issue a list of patented active ingredients of allopathic medicines stating the expiration term of the patent and the name of the owner (47 Bis List); on the other hand, the MH may request the applicant of an authorization to prove that it is the owner or recorded licensee of the Mexican patent, or state under oath that there is no patent in Mexico for the active ingredient contained in the pharmaceutical product; in this last case, the MH has to contact the MPTO to verify such statement.
If the MPTO fails to answer within ten days after receiving the verification
request from the MH, the MH will consider there is no patent and may issue the authorization for the commercialization of the product.
The amended provisions expressly excluded from the 47 Bis List those
patents that protect production processes and/or formulation of medicines. Of course, it does not mean that third parties are free to infringe these sort of patents, although the existence of the patent will be not as evident for the MH as in the case of the listed products, and stopping the commercialization of the infringing medicines later will be as difficult as it is now.
On November 17, 2003, the MPTO published the 47 Bis List. In theory the
list is intended to block third parties form trying to obtain the MH’s authorization for a generic product due to the existence of a patent on the relevant active ingredient; however, there is no way to assure that the 47 Bis List will be that effective.
You and your clients may want to verify that the information contained in
the published 47 Bis List is accurate. The following is the list of the patents involved in the publication:
Patent No. Active ingredient (in Spanish) 183639 ABACAVIR 208686 ADALIMUMAB 182808 ANASTRAZOL 197681 APREPITANT 186552 ARIPIPRAZOLE 207246 ATAZANAVIR 178535 ATORVASTATINA 214428 ATORVASTATINA CRISTALINA 210935 ATRASENTAN 190105 CANDESARTAN 190978 CANGRELOR 185169 CAPECITABINA
G O O D R I C H , R I Q U E L M E Y A S O C I A D O S
186806 CASPOFUNGINA 188780 CEFEPIME 200516 CELECOXIB 184814 CISATRACURIO BESILATO 178820 CLOPIDOGREL 189647 DELAVIRDINE 181403 DOCETAXEL 177265 DOFETILIDE 182605 DOLASETRON MESILATO 181349 DONEPECILO CLORHIDRATO 181723 DORZOLAMIDA 192812 EFAVIRENZ 183407 ELETRIPTAN 188551 ERTAPENEM 208595 ETORICOXIB 181201 EXEMESTANO 196935 EZETIMIBA 177770 FINASTERIDA 179953 FLUVASTATINA 181348 GRANISETRON 181402 IBANDRÓNICO 190786 IMATINIB MESILATO 178720 INSULINA 176397 IRBESARTAN 176805 LAMIVUDINA 193791 LAMIVUDINA 182131 LANSOPRAZOL 205143 LASOFOXIFENE 200835 LASOFOXIFENE 174756 LETROZOL 183197 LEVOFLOXACINO 197282 LINEZOLID 205936 LOPINAVIR 178771 LOSARTAN 173359 MEROPENEM 175371 MIZOLASTINE 177872 MOFETILO MICOFENOLATO 190796 MOLGRAMOSTIM 177307 MOMETASONA 179763 MONTELUKAST 189629 MOXIFLOXACINO 186561 NADROPARINE CALCIUM 191584 NELFINAVIR MESILATO
G O O D R I C H , R I Q U E L M E Y A S O C I A D O S
176695 NEVIRAPINA 173791 OLANZAPINA 184567 OPRELVEKINA 185996 PAMIDRONATO DISÓDICO 177372 PANTOPRAZOLE 181354 PIOGLITAZONA 181303 PRAMIPEXOL 181203 QUINUPRISTINA 179117 RABEPRAZOLE 194909 RALOXIFENO 179683 RALTITREXED 183546 REMACEMIDE 176311 RISPERIDONA 191767 RITONAVIR 189544 RIZATRIPTAN 189259 ROBALZOTAN 194277 ROFECOXIB 178451 ROPIVACAINA CLORHIDRATO 194435 ROSIGLITAZONA 182960 SALMETEROL 173630 SAQUINAVIR 177057 SIBUTRAMINA 181244 SILDENAFIL 179644 SUMATRIPTAN 185242 TACROLIMUS 196955 TADALAFIL 189745 TEGASEROD 191778 TELITROMICINA 190103 TELMISARTAN 185142 TIOTROPIO 188859 TIROFIBAN 183747 TOLCAPONA 211935 VALDECOXIB 195601 VALGANCICLOVIR 177165 VALSARTAN 207031 VARDENAFIL 178370 VENLAFAXINA 180362 VERTEPORFIRINA 178140 VORICONAZOLE 173362 ZIPRASIDONA 203066 ZIPRASIDONA 184189 ZIPRASIDONA 174759 ZOLENDRÓNICO
G O O D R I C H , R I Q U E L M E Y A S O C I A D O S
185978 ZOLMITRIPTANO
If you need additional information, we will be glad to provide it: It is unclear what would be the legal consequences of the MPTO’s failure
to include in the 47 Bis List a patented active ingredient that should have been published. In theory the 47 Bis List is not intended to limit in any way the patent rights, and the failure of the MPTO to include certain patented active ingredients should not limit the ability of a patent owner to file infringement actions. However, this is a questionable, and therefore dangerous issue.
We do not know either if the MPTO will publish additional 47 Bis Lists in
It is also unclear what would be the legal remedies available to force the
MPTO to include a patented active ingredient in the 47 Bis List. It would be necessary to analyze each case to determine what would need to be done to avoid potential adverse effects associated to the MPTO’s failure to include certain active ingredients in the 47 Bis List.
It was obvious that the intention of the government was to enhance the
protection of patents on pharmaceuticals, and improve the communication between the MPTO and the HM. However, the amendments were very poorly drafted and they raise too many questions about its potential effectiveness or even if the amendment will actually result in a limitation of the patent rights in Mexico.
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