U.S. wants patent form recall

Source: The Hindu | April 15, 2018

Submission on interpretation of a domestic patent law raises eyebrows

The United States Patent and Trademark Office (USPTO) has demanded the elimination of ‘Form 27’— a statutory requirement unique to India’s patent law that mandates patent holders to declare how a monopoly is being exercised in the country.

The submission by the U.S. government Continue reading

Posted in Indian Patent Law, Indian Patent Office, IP Rights, IPR, Patent Enforcement, Patent infringement, US pressure on India | Leave a comment

Will the Trump tariffs on China raise drug prices for Americans?

by Ed Silverama, StatNews | April 4, 2018

Now that the Trump administration has proposed 25 percent tariffs on thousands of Chinese-made products, including raw ingredients for a slew of medicines, there are concerns that prices for these products may rise, although experts caution the long-term impact remains unclear.

Among the medicines that could be affected are insulin, epinephrine, heparin, antibiotics, antidepressants, tranquilizers, and vaccines, according to the list released by the U.S. trade representative. However, the agency cautioned that the list, which also includes numerous raw ingredients, is incomplete and not intended to “delimit, in any way, the scope of the proposed action.” Continue reading

Posted in Drug prices, Generics, Uncategorized | Leave a comment

Dutch hospital challenges big pharma by making own version of very pricey drug

by Robin Pascoe, The Dutch News | April 5, 2018

Amsterdam’s AMC teaching hospital is to start making its own version of a licenced drug to treat a rare metabolic disorder because the medicine is no longer covered by health insurance after the price shot up. The drug, chenodeoxycholic acid or CDCA is produced by Italian pharmaceuticals company Leadiant. On April 1, the company ramped up the price by around 500% so it now costs some €200,000 per patient per year. The hospital can produce the drug for €25,000. Hospital pharmacies make their own medicines more often but this case is unusual because of the financial considerations. The hospital is offering ‘a social and economically-responsible alternative to a registered medicine which is so expensive that it is inaccessible to patients,’ the AMC said. Just 60 patients in the Netherlands suffer from the disease CTX which the drug is used to treat. The drug has been available since the 1970s but Leadiant only registered it as an orphan medicine with the European medicines agency last year. Orphan status, given to drugs which are used to treat very specific and rare illnesses, means a drug cannot be copied for a 10-year period.  Continue reading

Posted in Bad Pharma, Drug prices, Uncategorized | Leave a comment

India’s ailing battle against TB: One in five multidrug-resistant patients do not complete treatment

By Swagata Yadava, FirstPost | April 10, 2018

New Delhi: Nearly one in five multidrug-resistant (MDR) tuberculosis (TB) patients put on treatment in the public sector were lost to follow-up (LFU). This means that they either did not start treatment or their treatment was disrupted for more than two months.

India has approximately 2.8 million TB patients, a quarter of the world’s total TB cases. Of these 147,000 cases (5.4 percent) are MDR TB cases – resistant to the first line TB drugs rifampicin and isoniazid. These cases are more difficult and expensive to treat. Continue reading

Posted in Tuberculosis (TB), Uncategorized | Leave a comment

Why do new medicines cost so much, and what can we do about it?


The cost of new drugs is putting increasing pressure on people in both rich and poor countries. We explain why it’s a burning issue

by Sarah Boseley Health editor

Why does it matter what medicines cost?

If you are lucky enough to live in a country with comprehensive state-funded healthcare, such as the UK, you probably have no idea how much medicines really cost. But it can be a lot. Some drugs that have been around for ages are very cheap – aspirin, for instance, costs pence. It’s been out of patent and made by numerous companies competing to undercut each other’s price for decades. But new medicines, protected by 20-year patents, can cost hundreds of pounds a packet and sometimes thousands. The new breast cancer drug Kadcyla weighed in at a starting price of £90,000 per patient per year in the UK in 2015, though the manufacturer has now agreed a hefty discount for the NHS. Continue reading

Posted in Doha Declaration, Patent, R&D, TRIPS, TRIPS flexibilities, TRIPS plus, Uncategorized | Leave a comment

Less than four percent of private investment in health R&D targets the developing world

by Liz Sablich, Brookings 

A recent report published by the Brookings Private Sector Global Health R&D Project found that the private sector devotes at least $159.9 billion to investments related to health research and development (R&D) annually. That total includes $156.7 billion from pharmaceutical companies and $3.2 billion from venture capital firms, and encompasses investments focused on both the developed and developing world. But when the researchers further broke out the spending, they found that an exceedingly small share was dedicated to the developing world.
Private sector spending on overall health, global health, and neglected disease R&D, 2016. The figure below summarizes the private sector spending on overall health R&D, global health R&D (that is, spending that emphasizes medical treatments in the developing world), and neglected disease R&D. Of the total $159.9 billion spent on overall health R&D, only 3.7 percent, or $5.9 billion was focused on the developing world, with $5.6 billion coming from pharmaceutical firms and $225.8 million from venture capital companies. The researchers also examined what share of private sector investment was directed toward drugs, vaccines, and therapeutics to treat 35 specific illnesses that primarily afflict impoverished nations. These neglected diseases attracted the least private R&D money. According to the report, neglected disease R&D spending totaled $511 million (with $471 million coming from pharmaceutical funders and $40 million from impact investors).

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Maximizing the impact of global health R&D will require a sustained effort on the part of the private as well as the public and charitable sectors. And these current levels of private sector funding fall short of what is required to help people in the developing world deal with illnesses such as HIV/AIDS, tuberculosis, and malaria.

For that reason, the Brookings Private Sector Global Health R&D Projecthas emphasized ways to strengthen private investment in global health R&D. The third report published by the project provides a detailed overview of the factors limiting private sector investment, and each of the publications associated with the project includes recommendations for increasing such investment. A March 2018 blog post identifies and summarizes five potentially high-impact ways to improve private investment in global health drugs and vaccines. They include:

  1. Lower barriers to investment
  2. Increase legal flexibility
  3. More systematic and transparent data
  4. Lower cost structures
  5. Lower cost structures
Posted in R&D, Uncategorized | Leave a comment

The Power of TRIPS Flexibilities in Medicines Procurement

Source: Medicine Law & Policy

The government of Malaysia has began to roll out treatment of people infected with the hepatitis C virus (HCV).  Treatment will be a combination of antivirals (sofosbuvir and daclatasvir) from generic producers, including the Egyptian company Pharco, which has offered the curative 12 week HCV treatment for US$ 120. Egyptian companies are able to make generic HCV medicines because relevant patents on sofosbuvir and daclatasvir do not exist in Egypt.  Continue reading

Posted in Compulsory Licensing, TRIPS flexibilities, Uncategorized | Leave a comment