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Globally patent battles for Sovaldi's commercialisation: end result may bring bad news for patients

Drug Regulatory Authority of Pakistan's (DRAP's) recent decision to register Sovaldi came at a time when globally patent battles over the lucrative market for the treatment of Hepatitis C are escalating and the end result of these legal scrambles can bring bad news for the patients in lower and middle income countries like Pakistan, according to stakeholders here.

The exclusive pharmaceutical that has successfully attained registration for this landmark drug is Ferozsons, which previously entered an agreement with Gilead pharmaceutical to market and distribute certain medications for the treatment of chronic Hepatitis-C; HIV and chronic Hepatitis-B virus (HBV) infection in Pakistan.

In such a situation, they said, where several global giants like Roshe, Merck and AbbVie have entered in legal battles with Gilead sciences in different courts, the dilemma of exprts is whether DRAP can ensure the continuous availability of the miracle drug in the future when it has exclusively allowed one pharmaceutical to import and distribute Sovaldi.

These firms and Cambridge drug developer Idenix Pharmaceuticals Inc claim that Sovaldi contravenes their patents or contract rights and they deserve a cut of its Gilead's sale which was estimated $5 billion in the first half of 2014 thus making the said drug best selling prescription medicine in the history.

Already the price of $20 for one pill has stunt the masses where the majority of hepatitis C patients live under poverty lines and making both ends meet is a daunting task. Given the situation, rejecting the other 37 applications to the market the miracle drug seems a move that will only cater and bring relief to only a very small portion of the population.

Pakistan where the disease burden for hepatitis C is 11 million, the majority of the world's HCV-infected population, which is estimated at around 185 million people, lives outside of the wealthy regions of North America and Europe, as do most of the estimated 350,000 people who die every year from liver diseases associated with HCV infection.

The hepatitis C patent war looks extraordinary as branded drug makers are retaliating against branded drug makers rather than branded maker trying to prevent the competitors from selling cheap generic copies of their drugs.

Experts in the pharmaceuticals industry said what is more attractive about Sovaldi is, it is offering a cure which eliminates the hepatitis C virus altogether and that too with a shorter treatment duration and more tolerable side effects. Moreover, it could prevent the need of liver transplants in more severe cases. It is for this reason, AbbVie, Merck and Bristol-Myers Squibb Co are planning to bring their own new regimens to market to compete with Gilead's.

Gilead is fielding against all these lawsuits filed by Abbvie and other companies and believes that it has sole right to commercialise Sovaldi and products containing Sovaldi's active ingredient known as Sofosbuvir.

Recently, Merck agreed to acquire Idenix's pharmaceuticals for $3.85bn to widen its arsenal in the battle against Gilead as Idenix has developed an experimental drug with similar mechanism to Sovaldi. Meanwhile, Roche is expecting an arbitration decision later this year in which it is seeking ruling that it has an exclusive license to Sovaldi for it collaborated in research with Pharmasset in 2004 that developed the drug and was acquired by Gilead in 2012 for more than $11 billion. And AbbVie has accused Gilead for focusing on profits to recover inflated price that it paid to acquire Pharmasset.

Copyright Business Recorder, 2014


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Banking Review 2014

Foreign Debt $61.805bn
Per Cap Income $1,386
GDP Growth 4.14%
Average CPI 8.6%
Trade Balance $-2.378 bln
Exports $2.016 bln
Imports $4.394 bln
WeeklyJuly 23, 2015
Reserves $18.677 bln