MAD 4 IP: March 2012

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Bayer V. NATCO: NATCO granted compulsory licence for Nexavar

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The Controller General, P.H.Kurian issues order granting first of its kind Compulsory License in the matter of NATCO Vs. BAYER on 9^th March, 2012 for drug Nexaver (Sorafenib Tosylate) as per the section 84 of the Indian patent Act, 1970. Nexavar is the first-line treatment for liver and kidney cancer. Such landmark order is going to work as a catalyst in the chain reaction for compulsory licence in India. It will not be exaggerative to say that 9^th March should be celebrated as “Compulsory Licensing Day” in India.

Brief summary of the order:

The Compulsory License, first of its kind granted, enables NATCO

to sell the drug at a price not exceeding ₹ 8880 for a pack of 120 tablets (one month’s therapy) against ₹ 284,428 being the cost of Nexavar sold by Bayer.
The license is valid till the expiry of the patent – 2021.
The order is subject to certain conditions such as maintaining account of sales, and
Payment of royalty at 6% of the net sales on a quarterly basis etc.
The order also makes it obligatory for NATCO to supply the drug free of cost to at least 600 needy and deserving patients per year. (Generousness of this order…!!!!!)

In the case of life-threatening diseases, it is the price of life saving drug which threatens the patients instead of severity of symptoms, isn’t it? This order will pave the way for patients (also generic companies) to save their life from life-threatening diseases such as cancer, AIDS etc. by enabling the availability of such drugs at affordable price.

P.S. – The image Bye-Bye depicts both the “happy departure of P.H.Kurian, Controller General” as well as “the grant of compulsory licence to NATCO & saying Bye-Bye to Bayer”.

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Patent History of the Serial Pain-killer: Aspirin

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Hi IP MADs,

IP History updates - March 6, 1899- Bayer patents aspirin.

Aspirin, sailing its journey beyond a century, is a good example of understanding the importance of Intellectual property laws viz., patenting blockbuster innovative drug and creating and advertising brand image by trademark.

Biggest blockbuster

Aspirin is still the most versatile and effective medicine on the pharmacist’s shelf even after more than a century of history. Aspirin, also known as 'acetyl salicylic acid', has a chemical formula of C9H8O4.Aspirin, one even after the first drugs to come into common usage, is still the mostly widely used in the world - approximately 35,000 metric tonnes are produced and consumed annually, enough to make over 100 billion standard aspirin tablets every year.

<----- Image:1899 Aspirin Bottle First Bottle of Aspirin

Origin of word Aspirin

The folks at Bayer came up with the name Aspirin, it comes from the 'A" in acetyl chloride, the "spir" in spiraea ulmaria (the plant they derived the salicylic acid from) and the 'in' was a then familiar name ending for medicines.

As understanding of aspirin's properties has grown, its therapeutic applications have widened. It first became established as a household analgesic and antipyretic but recognition of its antiplatelet activity led to its emergence as an important tool in the management of cardiovascular and cerebrovascular disease. There is increasing evidence that it reduces the risk of some cancers and certain pregnancy complications.

(Controversial) Brain Behind Aspirin

Felix Hoffmann (January 21, 1868 – February 8, 1946) was a German chemist, credited for the first synthesized medically useful forms of heroin and aspirin, though some sources maintain that Arthur Eichengrün was the real creator of the latter. Hoffmann was born in Ludwigsburg and studied Chemistry in Munich. In 1894, he joined the Bayer pharmaceutical research facility in Elberfeld.

In 1949, Arthur Eichengrün published a paper in which he claimed to have planned and directed the synthesis of Aspirin along with the synthesis of several related compounds. He also claimed to be responsible for Aspirin's initial surreptitious clinical testing. Finally, he claimed that Hoffmann's role was restricted to the initial lab synthesis using his (Eichengrün's) process and nothing more.

(Eichengrün A. 50 Jahre Aspirin. Pharmazie 1949;4:582-4.)

Hoffmann's laboratory record for 10/10/1897

(Source: Bayer AG)

US Patent for Aspirin (1900)

(Source: Bayer AG)

Various Formulations & drug combinations

Aspirin was first sold as a powder. In 1915, the first Aspirin tablets were made. Interestingly, Aspirin ® and Heroin ® were once trademarks belonging to Bayer. Afte Germany lost World War I, Bayer was forced to give up both trademarks as part of the Treaty of Versailles in 1919. Now-a-days there exists numerous formulations containing Aspirin alone as well as other drugs.

Creating Brand by Extensive Advertisements

Bayer began advertising directly to American consumers just before the expiration of the aspirin patent. This ad, from the New York Times, February 19, 1917, emphasizes Bayer as the "One Real Aspirin" in anticipation of legal competition in the American market.