BDR’s compulsory licensing application for Dastanib was rejected by the Indian Patent Office, owing to insufficient effort by BDR to take a voluntary application

It has been more than a year since the first compulsory license was granted to an Indian company manufacturing generic drugs to produce a patented drug. In March 2012, the first compulsory license was granted to Natco for manufacturing sorafenib tosylate (brand name Nexavar), a drug whose patent was owned by pharma giant Bayer Corporation, which has been discussed here, here and here. 
Even before the dust has settled about India’s first compulsory license, there has been a rejection of compulsory license by the Indian Patent Office for an anti-cancer drug Dastinib. The order states that BDR had submitted that it would make the drug available at Rs 135 per tablet, working out to Rs 8,100 per month, per patient. Bristol-Myers sold the drug at Rs 2,761 per tablet, working out to Rs 1,65,680 tablets per month,  per patient.
The application was rejected on procedural grounds. Under Indian Patent Law, a Compulsory License applicant before applying for a Compulsory license must first attempt to procure a voluntary license from the patentee. If this attempt does not come to fruition within 6 months of the initial request, the applicant is free to file a Compulsory license application. BDR initially sent a request for a voluntary license to BMS. In response to this, BMS reverted with a series of questions which challenged the credentials and capability of BDR’s GMP requirements, quality assurance, due diligence etc. BDR assumed this reaction as an indication of rejection of the application for voluntary license. Following which, BDR did not take any action and also did not demonstrate any efforts to retaliate in its defense and exercised the option of filing of compulsory license.
In light of the above, the Patent Office rejected BDR's application on the grounds that they did not make enough efforts to obtain a voluntary license for the drug.  Chaitanya Prasad, Controller General of Patents, noted that there was "deliberate intent on part of the applicant (BDR) to refrain from entering into any kind of dialogue with the patentee for the purpose of securing the grant of a voluntary licence and the exercise of a deliberate choice to only invoke the provisions relating to the compulsory licences without taking the requisite steps laid down by the law, cannot be classified as an irregularity in procedure/timeline, which can be waived, condoned or declared to be not applicable." 
The rejection order can be viewed here

Pharma Patent Infringement Cases in India

The below table provides patent infringement cases in India with respect to Pharma:

S.No.	Court	Plaintiff	Defendant	Drug involved	Cost of Patented drug	Cost of Generic version	Decision in the case/Case Note
1.	High Court of Delhi	F. Hoffmann-La Roche Ltd	Anr. vs Cipla Limited	Erlotinib (Tarceva)	Rs 4800 per tablet (month's dosage for a patient undergoing treatment for cancer is Rs. 1.4 lakh)	Rs 1600 per tablet (month's dosage for a patient undergoing treatment for cancer is Rs. 46,000/-)	Decision went in favour of Cipla. Delhi High Court  dismissed Hoffmann-La Roche's suit accusing Cipla of infringing Roche’s patent for its lung cancer medicine Tarceva
2.	High Court of Bombay	Farbewerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning a Corporation etc.	Unichem Laboratories and Ors	(Uni-Tolbid tablets) manufacture of new sulphonyl-ureas, salts of those compounds and of anti-diabetic preparation containing such compounds	Not available	Not available	Decision went in favour of Frabewerke Hoechst. The Court held that the patent was valid and was not liable to be revoked because the invention possessed utility, novelty and inventive step and was sufficiently disclosed.
3.	High Court of Delhi	Merk, Sun Pharma (Co Plaintiff)	Glenmark	Sitagliptin phosphate (Januvia)	-	30% cheaper than Merck. Overall savings could be around 5000 Rs/- per year	High Court has refused to impose an injunction on Glenmark’s sale of Sitagliptin. Case is  pending.
4.	IPAB	Roche	Sankalp Rehabilitation trust and Wokhardt	Pegasys (Hepatitis C drug)	436,000 rupees for a 6 month treatment	47,160 rupees for  a 6 month treatment	Decision went in favour of Sankalp Rehabilation Trust saying the invention was obvious.
5.	Delhi High Court	Roche	Cipla	Valcyte	Not available	Not available	Pending in Delhi High Court
6.	High Court of Madras	Wockhardt	Hetero Drugs	Nadifloxacin	Not available	Not available	Application for Interim injunction by Wockhardt to restrain Hetero and others from infringing its exclusive marketing rights on nadifloxacin
7.	IPAB	Bayer	Natco	Nexavar	US$5,200 (for 120 tablets, one month supply)	US$160 (for 120 tablets, one monthsssupply)	IPAB upheld Natco’s compulsory license. Decision went in favour of Natco
8.	Indian Supreme Court	Natco Pharma Ltd	Union of India & Others	Glivec (Beta Crystalline form of Imatinib)	$20 to $30 per pill	$2 per pill	Supreme Court held that beta crystalline form of Imatinib Masylate is not patentable because it was not an invention as it fell within the scope of section 3(d).

IPAB upholds Natco’s Compulsory License on Nexavar

Natco, Hyderabad-based generic manufacture, had filed for a Compulsory License on Bayer’s Cancer Drug Nexavar in July 2011 as the reasonable requirement of public was not met, drug was not available to public at reasonably affordable prices, and that the patentee failed to work the invention within the territory of India.

Based on the aforementioned reasons, India’s first compulsory license was granted to Natco. However, Bayer, German manufacturer of Cancer drug Naxevar, was highly disappointed with the ruling and thus appealed to The Intellectual Property Appellate Board. More details about the case can be found here

image taken from here

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on this Monday. It also ruled that under the license Natco must pay 7 percent in royalties on net sales to Bayer.

What would this ruling mean?

•  Price of the ant-cancer drug, Naxevar would come down remarkably. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much as Bayer’s.

•  Encourage more generic companies to traverse the same path, and apply for Compulsory licenses to bring down healthcare costs and provide access to affordable drugs to treat diseases such as cancer, HIV and hepatitis.

• Pharmaceutical Research and Innovation may take a step –back.

• Affect the overall International Patent System.

 Bayer is disappointed with the ruling and has clearly expressed that it is not yet ready to throw in the towel. They are continuing the fight to overturn the decision in their favor by pursuing the case in Mumbai’s High Court.