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Microsoft word - gra-mexican patents-01-12-03.doc

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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 B O M C H I L , C A S T R O , G O O D R I C H , C L A R O , A R O S E M E N A Y A S O C I A D O S ARGENTINA, BOLIVIA, BRASIL, CHILE, COLOMBIA, COSTA RICA , ECUADOR, EL SALVADOR, GUATEMAL A, HONDURAS, NICARAGUA, PANAMA, PARAGUAY, PERU, PUERTO RICO, REPUBLICA DOMINICANA, URUGUAY, VENEZUELA 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 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.

Source: http://goodrichriquelme.com/wp-content/uploads/2011/05/GRA-Mexican_Patents-01-12-03.pdf

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