Indian Takers

  • by: |
  • 05/02/2013

A new op-ed appearing in The Washington Times. Please excuse the headline – I didn’t write that. I support quality, legal generic medicines. I do not support the blatant disregard of intellectual property – or the dangerous and deleterious consequences such behavior has on the public heath.

When generics win, patients lose

Failure to protect patents stifles drug profits and innovation

 

A court ruling in India could stifle medical innovation worldwide.

On April 1, the Indian Supreme Court rejected a patent request for a version of the cancer treatment Gleevec, citing a 2005 law intended to thwart companies from obtaining fresh patents for minor changes to a medicine. The law itself, and the court’s decision, is a boon to India’s prosperous $26 billion generic-drug industry. The blatant failure to protect the intellectual property of biopharmaceutical innovators, though, will have terrible consequences for drug development and patient health.

Bringing a medicine to market is a long and complicated process. According to the Tufts Center for the Study of Drug Development, it takes 10 to 15 years for an experimental drug to reach the market. Including the costs of failures, each medicine costs an average $1.2 billion to develop.

Generic-drug manufacturers don’t have these massive upfront development costs. They don’t need to worry about investing in research and development for revenue. They piggyback on the research and investments of the pharmaceutical companies that create the brand names. India’s generic-drug manufacturers are among the largest in the world.

Gleevec, a cancer treatment from Swiss-based pharmaceutical company Novartis, was a major pharmaceutical breakthrough for cancer patients around the world. A patient advocacy group in Mumbai lauds it as “the only lifesaving drug” for chronic myeloid leukemia.

Gleevec is patented in nearly 40 countries, including China and Russia. Because the drug was introduced in India before the country enacted its first patent law in 2005, the treatment has gone unpatented.

When Novartis applied for a patent on a beta crystal reformulation of Gleevec, an important improvement that makes the medicine more stable, Indian regulators denied it, saying the difference between the two versions was too small. Novartis filed a petition with the Indian Supreme Court in 2009 to challenge the denial.

Novartis went to court not only to defend its patent interests for Gleevec, but also to defend the larger principle that intellectual-property protections are essential to innovation and the advances of medical science. The Indian Supreme Court’s decision essentially tells innovators not to bother improving on their products because they will reap no reward for doing so.

Some are trumpeting the case as a victory for patient access. The generic version of Gleevec costs about $175 per month per patient, compared with $2,600 for the brand-name drug.

The raw price comparison misses the point. Ninety-five percent of the 16,000 Indian patients prescribed Gleevec receive the medication at no charge through a program Novartis has established to ensure that poor, uninsured patients get the medications they need regardless of ability to pay. The other 5 percent are reimbursed or insured or are enrolled in a generous co-pay program.

Novartis has provided $1.7 billion worth of Gleevec to Indian cancer patients since 2002 and donated $2 billion worth of medicines to more than 100 million patients worldwide in 2012 alone.

Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.

Patent protection does foster continued progress. Sometimes progress comes in the form of a big breakthrough, but sometimes it’s just a matter of an incremental advance. Either way, the work behind new medicines should be protected.

The Indian Supreme Court’s ruling is a blow to global public health. India’s generic-drug industry will profit, but patients will suffer the consequences.

Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog