Print Friendly, PDF & Email

Insights Daily Current Events, 20 January 2015

Insights Daily Current Events, 20 January 2015

Drug patent: Gilead prepares to appeal

The multinational pharmaceutical major, Gilead Sciences, has decided to appeal against the decision of the Indian Patent Office (IPO). IPO had rejected a patent application for its drug sofosbuvir. And this is likely to witness a long-drawn legal battle.

Background:

  • The IPO had rejected Gilead’s patent application covering the metabolites of sofosbuvir, although the main patent application covering sofosbuvir is still pending.
  • IPO had held the drug is a tweaked version of a known compound. Section 3(d) of the Indian Patents Act does not give patent protection to those compounds that are seen as tweaked versions of a known compound unless it shows greater therapeutic efficacy.

What’s next?

Gilead will approach the Intellectual Property Appellate Board (IPAB) or file a writ petition in the Delhi High Court.

Hepatitits C and Sofosbuvir:

Sofosbuvir is used to treat Hepatitis C, a viral infection affecting the liver. Left untreated, the infection can lead to liver cirrhosis or liver cancer and has a high mortality rate. The World Health Organisation estimates 150 million people globally are chronic Hepatitis C with the highest patient count being in China (29.7 million), India (18.2 million) and Egypt (11.8 million). Sofosbuvir with a 90 per cent cure rate, was introduced in the U.S. market in Nov. 2013. There was major opposition to this and Gilead last year entered into license agreements with seven large Indian generic companies to make the drug to sell it in 91 countries with a royalty payment.

Indian patent office:

The Indian Patent Office is administered by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM). The Office of the Patents, Designs and Trade Marks (CGPDTM) is a subordinate office under the Department of Industrial Policy and Promotion. The Controller General administers the working of the Patents Act, 1970,the Trade Marks Act, 1999, the Geographical Indications of Goods (Registration and Protection) Act, 1999 and the Designs Act, 2000 and also renders advise to the Government on matters relating to Intellectual Property Rights.

Indian patents Act:

The Patents Act, 1970 came into force in the year 1972, amending and incorporating the existing laws relating to Patents and Designs act 1911 in India.
Amendments (in 1999, 2002, 2005, 2006) were necessitated by India’s obligations under TRIPS, allowing product patents in drugs and chemicals.

Section 3(d):

Section 3(d), as introduced in April 2005 into the Indian patent law, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable, it must show an enhanced efficacy with respect to the known efficacy of the substance concerned.

Criticism:

  • The provision is disputed as being violative of TRIPS agreement not only on the ground that the provision does not provide any specific guidelines for incremental innovation but also lack the standard protection to all categories of inventions as provided by TRIPS.
  • The term efficacy mentioned in the provision is not clearly defined. The Supreme Court defines the scope of the term efficacy as therapeutic efficacy. However the scope of the term is unclear as to what count as therapeutic efficacy. The court fails to give the rationale as to why subject matter lacks enhanced efficacy.

Sources: The Hindu, Wiki, PIB.

New censor board chief

The government has put in place an entirely new censor board with producer Pahlaj Nihalani as its chairperson.

Censor Board:

Central Board of Film Certification (CBFC)/Censor Board is a Statutory body under Ministry of Information and Broadcasting, regulating the public exhibition of films under the provisions of the Cinematograph Act 1952.

  • Films can be publicly exhibited in India only after they have been certified by the Central Board of Film Certification.

Members: The Board, consists of non-official members and a Chairman (all of whom are appointed by Central Government) and functions with headquarters at Mumbai. It has nine Regional offices. The Regional Offices are assisted in the examination of films by Advisory Panels. The members of the panels are nominated by Central Government by drawing people from different walks of life for a period of two years.

At present films are certified under 4 categories:

Unrestricted Public Exhibition

Unrestricted Public Exhibition – but with a word of caution that Parental discretion required for children below 12 years

Restricted to 
adults

Restricted to any special class of persons

 

Sources: The Hindu, PIB, http://cbfcindia.gov.in/.

 

Over a billion live on less than $1.25 a day: Oxfam

According to a report by Oxfam released on the eve of the Global Economic Forum opening, if wealth concentration grows at the present rate, in another two years the top one per cent of the global population will earn more than the remaining 99 per cent.

Important observations made by the report:

  • Global wealth inequality has reached staggering proportions with 1 in 9 people not getting enough to eat and over a billion on less than $1.25 a day.
  • Since 2010, the richest 1% of adults in the world have been increasing their share of total global wealth.
    In 2010, the richest 80 people in the world had a net wealth of $1.3tn. By 2014, the 80 people who top the Forbes rich list had a collective wealth of $1.9tn; an increase of $600bn in just 4 years, or 50 per cent in nominal terms.
  • The poorest half of the world has seen an absolute decline in their share of the world’s wealth since 2010.
  • It has said that 85 billionaires have the same wealth as the bottom half of the world’s population.

 

Sources: The Hindu.