Basavanna's vachana

ಅತ್ತಲಿತ್ತ ಹೋಗದಂತೆ ಹೆಳವನ ಮಾಡಯ್ಯಾ ತಂದೆ,
ಸುತ್ತಿ ಸುಳಿದು ನೋಡದಂತೆ ಅಂಧಕನ ಮಾಡಯ್ಯಾ ತಂದೆ,
ಮತ್ತೊಂದ ಕೇಳದಂತೆ ಕಿವುಡನ ಮಾಡಯ್ಯಾ ತಂದೆ,
ನಿಮ್ಮ ಶರಣರ ಪಾದವಲ್ಲದೆಅನ್ಯ ವಿಷಯಕ್ಕೆಳಸದಂತೆ ಇರಿಸು,
ಕೂಡಲಸಂಗಮದೇವಾ. 

Meaning:

The one who would be an achiever would be the one with focus - on the right target. Having got to know the Glorious Lord Shiva, one needs to keep the mind fixed in God to continue to enjoy the Bliss the Lord showers. Digressing in focus would make one find at a much displaced location from the path towards the target.

“SOFOSBUVIR “-THE EXORBITANT SAVIOUR

Hepatitis C is a viral disease caused by the hepatitis C virus (HCV) that primarily affects the liver. HCV is spreads by blood-to-blood contact associated with intravenous drug use, unsterilized medical equipments, needle stick injuries in healthcare and blood transfusions. There is no vaccine to fight against hepatitis C. Prevention includes harm reduction efforts among people who use intravenous drugs and testing donated blood. Chronic infection can be cured about 90% of the time with treatments that include the medications Sofosbuvir or Simeprevir.


Hepatitis C is the leading reason for liver transplantation, though the virus usually recurs after transplantation. An estimated 130–200 million people worldwide are infected with hepatitis C. Estimated 1.2-2crore persons in India are infected with Hepatitis C. India did not have proper facilities to screen blood for Hepatitis C virus till 1996. Many people had received contaminated blood before 1996.


Sofosbuvir, an oral drug and the only cure – is a distant unaffordable luxury for many. Sofosbuvir had first received regulatory approval in the US in 2013, and has been priced by Gilead at US$ 84,000 for a treatment course, or $1,000 per pill in the US which had caused a worldwide debate on the pricing of patented medicines. But in contrast to this, a study from Liverpool University showed that Sofosbuvir could be produced for as little as $101 for a three-month treatment course.


A six-month treatment in India meant Rs 1.8 crores, which got reduced drastically to Rs 1.2 lakh after US-based Gilead Pharmaceuticals, manufacturer of the drug, licensed it to multiple generic Indian companies to make it available here. The list price in India as of April 26, 2016 according to the Asia Pacific Network of People Living with HIV, was $384 per bottle, or about $14 per pill due to the generic manufacturers.


In 2015 the Indian Patent Controller rejected one of Gilead’s key patent application titled "A (2'R)-2'-DEOXY-2'FLUORO- 2'-C-METHYL NUCLEOSIDE" with application number 6087/DELNP/2005, which covered the drug Sofosbuvir, marketed under the name Sovaldi.


Reasons for the Gilead patent being rejected in India in 2015: Section 3(d) of the IPA which quotes:


“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant".


Explanation.—for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers and mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”


Accordingly the IPO rejected patent to Sofosbuvir on the grounds that Gilead’s patent application had


· Represented only minor changes to a previous formulation, indicating that no new reactant was used resulting in a new product and it was merely a new form of a known substance that did not have enhanced therapeutic efficacy and thus was a violation of sec 3(d).


· The company already had licensing deals with manufacturers in India.


Both the opponent and applicant have argued based on the below two case laws


· Novartis Vs. Union of India (AIR 2013 SC 1311)


· F. Hoffman la Roche Ltd and Anr. Vs. Cipla RFA (OS) 92/2012


But a year later in 2016 the patent has been granted to Gilead on the grounds that the IPO has found the “Compounds to be novel and inventive”. This without considering the issue under sec 3(d) of IPA that, if at the time of filing the patent application (read PS) did the applicant claim that the compound is more efficacious than a previously known compound or not!! This keeps the door open for further appeal and a possibility of a compulsory license in future if need persists.


Sec 3(d) was also the center for controversy in 2013 when the Indian Supreme Court had rejected Novartis’s patent application for anti cancer drug , Glivec .


Patents guarantee drug makers exclusive sales for a decade or more, before letting in generic players, so the companies can recoup their investment and use profits to develop new medicines. In a country like India where majority of the population is not covered under any health insurance scheme and are also not in a position to afford expensive health care and drugs, patenting essential drugs can lead to long term health disasters. The need of the hour is to strike a balance between pharmaceutical innovations and public health such that there wouldn’t arise a situation in future where one has to pick one above the other.