Join        Login             Stock Quote

Supreme Court Gives Landmark Ruling Against Novo's Overly Broad Prandin Patent

 April 19, 2012 05:35 PM

In a landmark decision for generic companies, the Supreme Court recently ruled in favor of Caraco Pharmaceutical Laboratories Inc., an arm of India's Sun Pharmaceutical, in its patent litigation against Novo Nordisk. The dispute was over Caraco's generic version of diabetes treatment Prandin.

The court ruled that Caraco could challenge Denmark-based Novo for filing an overly broad patent claim description with the FDA, thus preventing Caraco from marketing a competing generic of Prandin. Now, Caraco can bring a counterclaim to correct Novo's use code.

The Supreme Court, in a unanimous opinion, concluded that Caraco can seek correction of Novo Nordisk's inaccurate use code regarding the combination use of repaglinide and metformin for the treatment of type 2 diabetes.

[Related -Initial Jobless Claims Rose Unexpectedly]

Regulations on use code requirements, however, have not yet been commented on by the FDA or US government, and it remains to be seen whether this will come soon.

Justice Elena Kagan wrote, "a generic manufacturer may employ a counterclaim provision to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using a drug."

The ruling is considered as a significant positive for the generics industry which alleges that the branded pharma companies try to delay cheaper generic alternatives by abusing the Food and Drug Administration approval process to avoid competition.

Caraco and Sun Pharma allege that Novo extended its monopoly over Prandin until 2018 by overstating the reach of their patents.

[Related -All Quiet on the Record High Front]

"This is a win for the generics industry regarding delaying tactics (like this one) by the branded sector," UBS analyst Marc Goodman wrote in a note to clients.

However, it is uncertain whether this ruling will prevent future lawsuits, as the current FDA guidance to branded manufacturers as to what is required in use codes is "remarkably opaque" according to Justice Sonia Sotomayor.

Sun Pharma is pleased that this landmark decision will help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to the USFDA.

Caraco's abbreviated new drug application (ANDA) for generic Prandin, which fetched about $230 million sales in the U.S., is still awaiting approval at the USFDA. Also, a separate appeal concerning the validity of patents for Prandin is currently pending before the Court of Appeals for the Federal Circuit after a lower court ruled in favor of Caraco.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageInitial Jobless Claims Rose Unexpectedly

Claims unexpectedly rose in the latest report through last weekend to breach 300,000 for the first time read on...

article imageAll Quiet on the Record High Front

What can we glean from the media’s lack of attention to the market’s recent record read on...

article imageThe Chip Maker Short Sellers Should Be Watching

Investing in semiconductor stocks is always tricky. Industry cycles can lead to bumps in the road for the read on...

article imageChicago Fed: US Economic Growth Slowed In October

The pace of US growth slowed more than expected in October, according to this morning’s update of the read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.