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Sunday, June 23, 2013

Abbott entity sues Reddy's over patented thyroid injection 'Zemplar'

This story first appeared in DNA Money edition on Thursday, June 20, 2013.

US-based AbbVie Inc, a spun-off entity of of Abbott Laboratories, has dragged Dr Reddy’s Laboratories (DRL) to court over its patented thyroid injection Zemplar.

AbbVie has alleged that DRL infringed its patents on six counts.

“DRL committed an act of infringement by filing an ANDA (Abbreviated New Drug Application) with a Paragraph IV Certification that seeks FDA-marketing approval for DRL generic versions of AbbVie’s paricalcitol injection products prior to expiration of the patents-in-suit,” goes the petition filed by AbbVie along with Wisconsin Alumni Research Foundation (WARF) in the US District Court for the District of Delaware.

Zemplar (generic paricalcitol) is a drug used for the prevention and treatment of secondary hyperparathyroidism (excessive secretion of parathyroid hormone) associated with chronic renal failure.

According to its annual report, AbbVie made $383 million from Zemplar sales in 2012, including $230 million from the US.

As per the petition, DRL filed an ANDA with the US Food and Drug Administration (USFDA) seeking approval to sell a generic copy of Zemplar injectable products in 2 microgram/ml and 5 microgram/ml formulations prior to the expiration of the patents owned by and exclusively licensed to the complainants.

A Dr Reddy’s official called it a routine matter with no additional information to share.

Analysts tracking the developments echoed the sentiment, terming it positive for DRL and cited the infringement case as part of the patent challenge in US generic filing process.

“Typically, a drugmaker files with the USFDA for approval to market a product and if the patent is existing, the company has to challenge it. DRL has just challenged the patent and as per law, AbbVie has responded within 45 days, else it would have been understood that the drug inventor agrees the patent is not valid and is giving it away. Suing DRL is nothing but a routine matter and part of business,” said a pharma analyst with a leading international brokerage.

Now that the complainants have filed a suit, as per US law, a 30-month stay gets levied on the DRL filing. Once the stay period gets over, the parties involved will start litigating over the patent. The matter is likely to take over 3-4 years to get sorted out.

The alleged infringement relates to three patents – patent numbers 799 and 758, which Abbott had transferred to AbbVie and which will expire on April 8, 2018, and patent number 815, which WARF holds the rights to and which will expire on July 13, 2015.

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