Today’s rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year. A look at the decision shows that a provision in India’s law continues to stop patent applications if they fail to show sufficient novelty and inventive step – and are subject to opposition.

The patent office decision dated 13 January is available here [pdf].

According to the decision, hepatitis C (HCV) is at epidemic levels, affecting some 170 million people worldwide, and 18 million in India. Others have put the global figure even higher.

The decision states that oppositions to several patent applications on sofosbuvir were filed by the Initiative for Medicines, Access & Knowledge (I-MAK), and the Delhi Network of Positive People (DNP+), in November 2013 and March 2014, arguing that they were not sufficiently novel and inventive as required for a patent. Gilead then made arguments explaining why these oppositions were not valid.

In its ruling, the Patent Office did not accept the company’s arguments, and suggested ways in which its arguments could have been more convincing, in particular to show “therapeutic efficacy” so as to satisfy Indian Patent Act Section 3(d).

Section 3(d) states:

(d) 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, 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;

Public health advocates were quick to say the outcome could lead to drastically lower prices for this drug.

“The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course,” Médecins Sans Frontières (MSF, Doctors without Borders) said in a release.

Gilead has signed voluntary licence agreements with a number of generic drug producers in India, but the agreements have limitations built in, MSF said. With this decision, companies that have not signed them are now “free to produce,” it said.

“Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug,” said MSF. “With the patent being denied, other companies that have not signed the licence are now free to produce.”

“Entry by additional generic manufacturers should increase the open competition needed to bring prices down dramatically, especially in those countries that have been excluded from the voluntary licence agreement, and thereby increase access to the medicine,” it added. “Countries where the drug is unaffordable, and which were excluded from the licences, should make every effort to import more affordable generic versions from other producers who did not sign a licence in India.”

MSF said it is expanding treatment for people with hepatitis C in nine countries, and has been negotiating access to this medicine, which it is said “is expected to become the backbone of any HCV regimen in the coming years.”

Gilead was not reached for comment on the outcome but at press time had not posted a statement on the decision.

‘Happy Day’ for Advocates

The MSF release included celebratory statements from the Initiative for Medicines, I-MAK, DNP+, and Dr. Andrew Hill, a researcher at Liverpool University. The statements are reproduced below.

“Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price. This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically. Gilead’s drug access programme for developing countries is already showing its limitations, with the company planning to impose conditions for the supply and distribution of the drug to patients and treatment providers in developing countries, in order to protect the company’s ability to charge unaffordable prices in wealthy countries. Getting sofosbuvir out of the stronghold of Gilead’s monopoly will be crucial to expanding treatment for people with hepatitis C globally. – Dr. Manica Balasegaram, Executive Director, MSF Access Campaign

“The move to reject Gilead’s patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug. The bottom line here is that India’s patent law doesn’t give monopolies for old science, for compounds that are already in the public domain. Gilead’s strategy of charging as much as US$84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is – seeking to squeeze as much profit out of the sick as possible.” – Tahir Amin, lawyer and Director of the Initiative for Medicines, Access &Knowledge (I-MAK.org)

“This is a happy day for the millions of people who urgently need hepatitis C treatment across the globe. People with hepatitis C everywhere should be able to have access to this treatment, but millions of our friends in middle-income countries have been left out in the cold by Gilead. This decision provides hope that people in countries that have been excluded from Gilead’s licensing deals will be able to access low-cost generic versions of sofosbuvir.” – Vikas Ahuja, Delhi Network of Positive People (DNP+)

“We know from various manufacturers in India that they could produce this drug in the future for as little as $101 for the full three month treatment course. That’s roughly $1 per pill, which is a big improvement over the $1,000 per pill Gilead is charging in some countries. At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world.” – Dr. Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics, Liverpool University

[Update:] MSF on 15 January issued a follow-up press release asserting that a Gilead program is set to restrict access and scale-up of HCV treatment, regardless of the patent controller decision. The release is reproduced below.

Barriers to access and scale up of hepatitis C (HCV) treatment: Gilead’s anti-diversion program

The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) began introducing hepatitis C (HCV) treatment to several patients in India in 2013, and is in the process of scaling up treatment for HCV in several additional countries. MSF plans to use direct acting anti-viral medicines that have recently come to market that have the potential to revolutionize treatment for people living with HCV. One critical drug that MSF will procure for use in its treatment programmes is sofosbuvir, which was launched by Gilead Sciences in 2013, and is marketed as Sovaldi.

As Gilead is the sole producer of sofosbuvir (no generic versions have been launched in any country), governments, MSF and other treatment providers are dependent on the willingness of the company to make this urgently-needed drug available and accessible.

In the course of discussions with Gilead to purchase the drug, MSF has learned that the company will institute an ‘anti-diversion’ programme in developing countries through its distributors and licensees (generics companies that have signed a voluntary license with Gilead) to prevent what they characterize as the possible ‘bulk diversion’ or re-sale of such medicines from low- or middle-income countries to high-income countries.

With this programme, Gilead is demanding that patients and treatment providers in developing countries comply with a web of onerous and potentially harmful procedures that aim to preserve Gilead’s ability to charge exorbitant prices in developed countries (up to US$1,000 per pill, or $84,000 per treatment course).

Gilead’s programme violates patient privacy and autonomy, undermines confidentiality of patient data, introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure. As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented.