Some Famous Cases: 1) Bayer Compulsory Licensing Case: Relevant section: Section 84 (1) of the Patents Act 1970. In 2008 Bayer obtained the patent for the anticancer drug Nexavar. On March 2012, Nacto was granted the compulsory license for the manufacture and marketing of Sorafenib tosylate. Bayer’s tablet cost INR 2500 while Natco’s INR 75. The reason for invoking CL: Bayer did not market the drug for 4 years after taking the license.
The generic drug: 1) Sorafenib was available from Cipla for Rs 27,960 2) Natco is providing the same at Rs 8,880/-. After the judgment for grant of compulsory license Cipla has slashed its price further and now it is available for Rs 6,600/- per patient per month. Per Capita Income of India (PCY) in 2011 - $1575/- and cost of Bayer’s Nexavar PP/Year in 2011 - $69,000/- and cost of Natco’s Sorafenib PP/Year in 2011 - $2,120/-. Hence, Bayer was charging almost 45 times the Per Capita Income of India of India. Hence to overcome this situation, the following happened: Natco, a generic drug manufacturing company requested Bayer for giving it a voluntary license.
ISSUE WITH COMPANY In January 2006, Novartis was denied a patent for India. The key issue was revolved around whether the Glivec is a new product under the terms of law. Novartis made an application for the patent rights and it got rejected as modified form of the drug was already in the market with 10% less cheaper cost. So Novartis filed the case in the Supreme Court challenging the rejection of the application. After 7 years of battle Novartis was again denied the patent right.
It is without a doubt that the creation of Teflaro®, followed closely by the FDA approval for pediatric patients last year May, was an enormous milestone for Allergan as a company and for our pharmaceutical industry as a whole. However, I believe that the recent announcement of the 550% price upsurge has truly crossed our ethical boundaries even if such a choice was FDA-approved. Referring back to one of your comments made during our conference this morning, you stated that we must not overlook the uniqueness of Teflaro® in its lightly-saturated market. Even though I well agree with you that Teflaro® currently stands out as one of the scarce drug prescriptions that can cure hypersensitive skin bacteria, it is still abusive for Allergan to adopt such an
Natco Pharma Ltd. vs Bayer Corporation. A controversial case for many reasons but one that piqued my interest in the importance of bioprocessing. It was on the 19th of March 2012 that I was going through an article from a scientific magazine. The Indian Government had granted its first compulsory license against Bayer’s patent on Nexavar, an anticancer drug, to Natco Pharma Ltd., an Indian generic drug company. Although, the focal point of this case was the issue of compulsory licensing, it led me to thinking about how the same product can be manufactured in multiple ways, thus altering consequences like cost of manufacturing, pricing and accessibility.
The project aims to look into look at both sides of the coin and hopefully come to a conclusion on how a balance can be achieved. Compulsory Licensing in the Pharmaceutical Sector March, 2012 was a historic day in terms of compulsory licensing in India. The first compulsory license was given to Natco to produce a generic version of
Assignment B6: Marketing Phase 1. BRAND NAME OF THE NEW MEDICINE The name of our new drug is Nervarin® (salizumab). Package design: PACKAGE INSERT Chapter A: Medical Plan (Hiba Saleh) The differences Phase III and Phase IV clinical studies Phase III is carried out on a large scale of patients in different countries. The patient population can exceed 30,000. Phase III tests the ultimate safety, efficacy and dosage of drugs as compared to the current standard treatment or placebo.
Introduction One of the Japan leading pharmaceuticals companies, Daiichi Sankyo, acquired in November 2008 for over 4 bln USD a controlling stake in Ranbaxy Laboratoires, Indian generics manufacturer. Both companies expected the deal to create significant synergy effect in long term. The benefit was supposed to result from the complementary businesses. The aim was to establish presence in all pharmaceutical areas – through the diversification initiatives – that would bring considerable cost saving for both merger participants. Challenges identified The main question is rather general: what went wrong or what could have been done better?
Intellectuaal Property, Antitrust and Cumulative Innovation in the EU and the US. Cornwall, Hart Publishing Ltd 2012, p 108-109.] This was later (in 2012) confirmed in the European Court of Justice. The case was the first in the pharmaceutical sector, to include restrictions of competition by the originator via delaying generic entry to the market. Therefore it was highly influential to the way companies structured their strategies to protect their brands after patent expiry.