Caraco Pharmaceuticals Vs. Novo Nordisk

The case of unclear and unfair patenting of generic drugs

• In September 2009, Caraco, a generic pharmaceuticals company, issued an injunction requiring Novo to change the code for its patent back to “use of repaglinide in combination with metformin to lower blood glucose” from a method for improving glycemic control in adults with type 2 diabetes mellitus”. This change hampers Caraco’s ability to bypass the patent and seek approval for using repaglinide by itself.

Case Overview

Case overview ctd.

• Novo Nordisk had obtained patents for the drug repaglinide, for which approval of FDA was received, of its use in the following ways:

1. Use of repaglinide by itself2. In combination with metformin3. In combination with another class of drug

After Caraco’s injunction, Novo Nordisk appealed. In April 2010, the Federal Circuit revised the case and deemed Caracao’s counter claim (that Novo did not claim any approved method) invalid, as Novo Nordisk’s patent did claim one of the approved methods of using the drug.

Case Overview ctd.

• In June 2011, the Supreme Court granted judicial review to evaluate whether

1. There is 'an approved method of using the drug' that the patent does not claim

2. The brand submits 'patent information' to the FDA that misstates the patent's scope, requiring 'correction.

Caraco Pharmaceutical• Here claims are made that in

the patent new information “a method for improving glycemic control in adults with type 2 diabetes mellitus”, interpreted by Caraco, as “not any particular method” and hence they claim that Novo did not claim any of the methods for using the drug, thus rendering it possible for Caraco to counterclaim the patent.

Novo Nordisk• Novo on the other hand

claims that by “a method” they mean, any method. Therefore only a claim can be made if Novo had not claimed any method, which according to them hey have.

The Arguments

Central Dispute

• Here the main issue is the lack of clarity in the patent information.

• Following the court, both parties are right in their arguments. However, when looking at the context of the statute, the court rules in favor of Caraco. The statute “contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones”.

Remedies

• The court mandated one of the following remedies:

1. Deletion of erroneous “patent information”

2. Correction of erroneous “patent information”

Implications

The Court’s decision has great implications for generic drug manufacturers as they are now able to bring counter claims to patents by large brand name manufacturers, as they abuse the use of patent codes, thus allowing them to “block generic competition as long as they maintained a patent on any use of the drug”

Source: Mondaq.com, “United States: Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole In Hatch-Waxman Act”

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