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Viewing cable 06LIMA2529, PFIZER WINS IPR CASE

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Reference ID Created Released Classification Origin
06LIMA2529 2006-06-26 13:10 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Lima
VZCZCXYZ0009
RR RUEHWEB

DE RUEHPE #2529/01 1771310
ZNR UUUUU ZZH
R 261310Z JUN 06
FM AMEMBASSY LIMA
TO RUEHC/SECSTATE WASHDC 1202
INFO RUEHBO/AMEMBASSY BOGOTA 3610
RUEHQT/AMEMBASSY QUITO 0499
RUEHLP/AMEMBASSY LA PAZ JUN SANTIAGO 0695
RUEHCV/AMEMBASSY CARACAS 9637
RUEHBU/AMEMBASSY BUENOS AIRES 2489
RUEHME/AMEMBASSY MEXICO 3399
RUEHBR/AMEMBASSY BRASILIA 6865
RUEHNE/AMEMBASSY NEW DELHI 0116
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC
RHEHAAA/NATIONAL SECURITY COUNCIL WASHINGTON DC
UNCLAS LIMA 002529 
 
SIPDIS 
 
SENSITIVE 
SIPDIS 
 
DEPT FOR WHA/AND, EB/IPE SWILSON 
COMMERCE FOR 4331/MAC/WH/MCAMERON 
DOC FOR J. BOGER 
USTR FOR BHARMAN 
 
E.O. 12958: N/A 
TAGS: ECON ETRD KIPR PE
SUBJECT: PFIZER WINS IPR CASE 
 
 
This cable contains business sensitive information.  Please 
protect accordingly.  Not for Internet distribution. 
 
1.  (SBU) Summary.  Pfizer, in 2002, filed a patent 
infringement case against Indian company Ranbaxy, alleging 
that the company was illegally copying its Lipitor patent. 
Indecopi, (Peru's IPR Administrator), issued two final 
decisions in June in favor of Pfizer, finding Ranbaxy guilty 
of violating Pfizer's patents and denying the Indian 
company's request for nullification of the Pfizer patent. 
With this action, Ranbaxy can no longer sell its copy of 
Lipitor on the Peruvian market, although it retains the 
right to sell other medicines.  The Indian company must also 
pay a fine of $8,500 to Indecopi.  Although Pfizer is 
pleased with the outcome, the case shows Indecopi's inherent 
deficiencies in protecting intellectual property rights. 
Post will continue to monitor the case in light of 
Indecopi's history of uneven enforcement actions.  End 
Summary. 
 
Lipitor Patent Copied 
--------------------- 
 
2.  In 2002, Pfizer, one of the ten pharmaceutical companies 
to hold patents in Peru, filed a patent infringement case 
against Indian company Ranbaxy, alleging that the company 
was copying its patent for Lipitor, also known as 
atorvastatin calcium.  (Note:  Lipitor, used to control 
cholesterol levels, is one of Pfizer's must successful 
drugs.  End Note.)  Several months after Pfizer filed its 
complaint, Indecopi, Peru's IPR Administrator, issued a 
precautionary measure against Ranbaxy based on possible 
patent infringement.  The precautionary measure prohibited 
Ranbaxy from selling the product in Peruvian markets, 
although it could continue producing the drug.  After 120 
days, per Peruvian law, the precautionary measure expired, 
allowing Ranbaxy to resume selling its product in the 
Peruvian market. 
 
Indecopi Fails to Act 
--------------------- 
 
3.  (SBU) During the past four years, Pfizer officials met 
frequently with Indecopi officials, who continued to drag 
their feet on the issue.  In 2003, per Indecopi's request, 
Ranbaxy presented Indecopi with confidential test data to 
prove that its drug was not a copy of Pfizer's patent.  In 
addition to the information, Ranbaxy argued that Lipitor is 
patented to treat cholesterol problems; Ranbaxy's drug 
instead sought to counter the effects of erectile 
dysfunction, with the side effect of lowering cholesterol. 
 
4.  (SBU)  As a result of Ranbaxy's actions, the Director of 
Indecopi's patent office informed Pfizer that the company 
needed to prove that Ranbaxy's drug was a pirated copy. 
Pfizer, noting that this practice appeared to be a violation 
of TRIPS, submitted information to Indecopi.  After a year 
of reviewing the case, Indecopi ruled in favor of Ranbaxy, 
stating that the Indian company's drug, while similar to the 
Lipitor patent, was created through a different chemical 
process.  Ranbaxy then petitioned Indecopi to nullify 
Pfizer's Lipitor patent. 
 
Pfizer Appeals and Wins Both Cases 
---------------------------------- 
5.  (SBU)  Pfizer immediately appealed both Indecopi's 
decision and Ranbaxy's request for patent nullification, 
providing Indecopi additional test data information.  In 
December 2005, Indecopi issued resolution 1468-2005, 
overturning its previous decision on the Ranbaxy drug. 
After reviewing the case, Indecopi found that both products 
were crystalline and shared the same spectrum 
characteristics.  Indecopi concluded that the Ranbaxy drug 
violated Pfizer's patent and dismissed the company's 
nullification request. 
6.  (SBU)  Ranbaxy appealed both of Indecopi's decisions, 
but on June 1, 2006, Indecopi, with resolution 692-2006, 
dismissed Ranbaxy's nullification request, upholding the 
2005 resolution in favor of Pfizer.  Indecopi's decision is 
final, although Ranbaxy can file a petition for judicial 
review within three months of the resolution (by September 
1, 2006). 
7.  (SBU)  On June 6, Indecopi issued an additional 
resolution, 729/2006, which found that Ranbaxy infringed on 
Pfizer's patent rights when marketing its drug in Peru.  Per 
the decision, Ranbaxy immediately halted the sale of this 
product, although it can sell its other drugs on the market. 
Ranbaxy must pay a fine of $8,500 to Indecopi to cover the 
costs of the hearings. 
 
Comment 
------- 
 
8.  (SBU)  While Pfizer is pleased with Indecopi's final 
decision, the patent infringement case lasted four years, 
costing the company more than $5 million in sales.  Two 
other U.S. pharmaceutical firms continue to face similar 
problems and await Indecopi action.  This case highlights 
the inefficiency of Indecopi's procedures and inability to 
protect pharmaceutical patents.  Indecopi officials 
recognize that there are flaws in the system and hope that 
the next Administration changes the process.   Post expects 
that Indecopi will request substantial technical assistance 
during the implementation of the FTA, in order to close 
loopholes, promote capacity building and improve its legal 
framework.  We are working with State, Commerce, U.S. Patent 
and Trade, and U.S. Customs to provide additional training 
when funding becomes available. 
 
STRUBLE