Since the last update:

Canada – Ranbaxy invalidates Enantiomer patent, litigation continues over Calcium salt patent (exp 2010) and Basic patent set to expire in May 2007.

Denmark – In a bold move, Ranbaxy launched generic Atorvastatin on 12 February 2007, prior to a determination of the injunction application or the patent litigation.

Most interesting here is the Danish move which seems to carry great risk. If, as in all other jurisdictions, Ranbaxy is found to infringe at least one of the litigated patents, then it will have to remove the product from the market (which itself is costly) and pay damages for Pfizer’s lost sales during the period of sale.

Also of note is that the Canadian decision invalidating the Enantiomer patent was based on the same arguments that were successful in Australia.

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My two most recent articles were:

Comment

Given the size of the market for Lipitor, even in small countries, Ranbaxy will only need to launch in a few to regain its litigation costs. Ranbaxy has launched the product in India and some other smaller markets to date.

Ranbaxy has had some success in invalidating the Enantiomer patent in various jurisdictions and consequently bringing forward the earliest possible launch date in those countries. However, the dates are still sufficiently far away (2010+), that competitor generic companies will be able to develop or in-license and launch their own atorvastatin products in time for expiry of the Basic Patent. They will obviously be grateful to Ranbaxy, but there seem to have been alternative strategies that could have been adopted here.

The scorecard

Country

Date

Comment

Austria

Oct 2006

Austrian Patent Office rules that Ranbaxy’s product would infringe the Basic patent.
 

Apr 2006

A five Judge panel of Austria’s Supreme Patent and Trademark Board held relevant claims of the enantiomer patent (AT 207896) to be anticipated and obvious in light of WO 89/07598 and US 4,681,893 respectively.

Basic patent in force until ~2011.

Australia

Dec 2006

Federal Court holds Basic patent (AU 601981) infringed and Enantiomer patent (AU 628198) invalid for False Suggestion and Inutility (lack of support for the claimed 10 fold increase in activity).

Click here for a case summary.

Canada

25 Jan 2007

Ranbaxy invalidates Enantiomer patent based on lack of enablement (lack of support for the claimed 10 fold increase in activity) in Canadian Federal Court.

Pfizer announces intention to appeal.

Calcium Salt patent litigation still pending (expiry in 2010).

Basic patent to expire in May 2007.
 

Dec 2006

Canadian Federal Court grants an order preventing Novopharm Ltd. from launching a generic version of Lipitor until expiration of the Enantiomer patent (CA 2,021,546) in July, 2010

Denmark

12 Feb 2007

Ranbaxy launches generic Atorvastatin in Denmark on 12 February 2007 prior to resolution of the patent litigation or indeed the injunction application due within weeks of the launch.)

Ecuador

Dec 2005

Andean Court of Justice dismisses invalidity case against Lipitor patents. The decision stops any further validity challenges in Ecuador, Peru and Venezuela.

European Patent Office

Oct 2006

European Patent Office issues an advisory opinion upholding validity of the Basic patent. (Decision in response to request from Madrid Mercantile Court No. 4.)

Finland

Feb 2006

Preliminary injunction granted against Ranbaxy (pending final outcome of trial).

Malaysia

Sep 2006

Ranbaxy launches first generic atorvastatin (Lipitor) in Malaysia.

Netherlands

Sep 2006

Three Judge panel of the District Court of The Hague in the Netherlands holds the Basic patent infringed by the proposed Ranbaxy product.

Enantiomer patent held invalid.

Expected launch date – November 2011.

Norway

Aug 2006

The Oslo City Court holds that two process patents (covering intermediate compounds) not infringed

Pfizer indicates intention to appeal.
 

Nov 2005

The Oslo City Court holds that of the four patents litigated, one is infringed (claiming a synthetic intermediate), one is not infringed (claiming a synthetic process), and the other two are not ruled on.

Ranbaxy files an appeal.

Peru

Dec 2005

Ranbaxy held to infringe enantiomer patent and enjoined from marketing.

Romania

Dec 2005

Pfizer prevails in court proceedings.

Spain

Oct 2006

At the request of Barcelona Mercantile Court No. 4, the European Patent Office provides an advisory opinion holding the Basic patent valid.

Ranbaxy issues statement to investors referring to the earlier Barcelona Mercantile Court No. 2 decisions and stating that the European Patent Office opinion is not legally binding.
 

Sep 2006

Barcelona Mercantile Court No. 2 finds claims 1 to 3 of the Basic patent invalid in two separate decisions (Lek Pharmaceuticals v. Warner Lambert Co. and Laboratorios Cinfa et al. v. Warner Lambert).

Madrid Court of Appeal rejects appeal in relation to enantiomer patent.
 

Dec 2005

Madrid Court of First Instance finds enantiomer patent valid and enforceable. (Other challenges pending.)

United Kingdom

Dec 2006

House of Lords denies leave to appeal for both parties to the dispute.
 

Jun 2006

Court of Appeal denies declaration of non-infringement but invalidates the enantiomer patent.

Click here for a case summary.

Basic patent still in force until 2011.

United States

Oct 2006

Court of Appeal for the Federal Circuit denies Ranbaxy’s petition for rehearing.

Pfizer announces intention to seek correction of the technical defect which invalidated the Basic patent.
 

Aug 2006

Court of Appeal for the Federal Circuit finds Enantiomer patent valid and infringed, but basic patent invalid (based on 35 U.S.C. 112 ¶ 4).

Click here for a case summary

The Basic Patent

Example family members:

CA 1268768; EP 247,633; JP 2019432; US 4681893

Example claim 1 (from the EP):

1. A compound of structural formula I EMI28.1 wherein X is -CH2-, -CH2CH2-, -CH2CH2CH2- or -CH2CH(CH3)-;
R1 is 1-naphthyl; 2-naphthyl; cyclohexyl; norbornenyl; 2-, 3-, or 4-pyridinyl; phenyl, phenyl substituted with fluorine, chlorine, bromine, hydroxyl; trifluoromethyl; alkyl of from one to four carbon atoms, alkoxy of from one to four carbon atoms, or alkanoyloxy of from two to eight carbon atoms:
either of R2 or R3 is -CONR5R6
where R5 and R6 are independently hydrogen; alkyl of from one to six carbon atoms; 2-, 3-, or 4-pyridinyl; phenyl; phenyl substituted with fluorine, chlorine, bromine, cyano, trifluoromethyl, or carboalkoxy of from three to eight carbon atoms;
and the other of R2 or R3 is hydrogen; alkyl of from one to six carbon atoms; cyclopropyl; cyclobutyl, cyclopentyl, cyclohexyl; phenyl; or phenyl substituted with fluorine, chlorine, bromine, hydroxyl; trifluoromethyl; alkyl of from one to four carbon atoms, alkoxy of from one to four carbon atoms, or alkanoyloxy of from two to eight carbon atoms;
R4 is alkyl of from one to six carbon atoms; cyclopropyl; cyclobutyl; cyclopentyl; cyclohexyl; or trifluoromethyl;
or a hydroxy acid or pharmaceutically acceptable salts thereof, derived from the opening of the lactone ring of the compounds of structural formula I above.

The Enantiomer Patent

Example family members:

CA 2021546, EP 409,281, JP3506336, US 5273995,

Example claim 1 (from the EP):

[R-(R*,R*)]-2-(4-fluorophenyl)- beta , delta -dihydroxy-5-((1-methylethyl)-3-phenyl-4-[(phenylamino)-carbonyl]-1H-pyrrole-1-heptanoic acid or (2R-trans)-5-(4-fluorophenyl)-2-(1-methylethyl-N,4-diphenyl-1-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1H-p yrrole-3-carboxamide; and pharmaceutically acceptable salts thereof.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.