In India Novartis Loses Patent Fight to Protect a New Version of an Old Drug

A Win for Indian Patients – and Maybe for the World

A pharmaceutical drug that is patented gives the manufacturer a huge profit opportunity.  And it should, since the manufacturer has invested millions in developing the drug and getting approval for its use.  But that protection has to be limited in time, and it is.  Eventually patent protection runs out and the drug can be sold as a generic.

Drug companies use a variety of methods to try and extend patent protection.  In the U. S. the Supreme Court will decide whether or not it is legal for drug companies to pay generic manufacturers NOT to make a drug that is losing patent protection.  (It is illegal, but who knows what the Court will say.)  Another trick is to make minor modifications in a drug and seek to renew the patent.  This is what Novartis did in India with a cancer drug.  But it didn’t work.  The India Supreme Court rejected Novartis’s claim.

Patents for amended versions of drugs can be granted in the United States.

But in a landmark judgment that is likely to set a legal precedent for similar patent claims in the future, the Supreme Court said that the beta crystalline form of the salt called imatinib mesylate in the drug fails the test of “invention and patentability.”

“The Supreme Court has said that product was known prior to 1995, and a new patent cannot be granted because it is just a little modification on the old one,” Pratibha Singh, the lawyer representing three Indian drug companies, told reporters in New Delhi. “This means that patents would be granted for only genuine inventions, and repetitive patenting will not be allowed. The court held that merely because it [the new version] is more soluble or more stable, it doesn’t qualify by itself for patent protection.”

Novartis and drug companies claim that decisions like this will delay or even prevent new drug development.  And that is true to some extent, there is no free lunch here.  But a large part of the problem is the avarice of the drug companies themselves.  They need to do a better job of balancing profits and pricing and the needs of patients for whom their products are literally life savers.  For example, price differentials between generics and protected versions should not be as high as they are.

Health activists and Indian drug companies have argued that most Indians cannot afford expensive patented drugs such as Glivec, which costs more than $2,200 per patient for 30 tablets in a month. The generic version being sold in India costs about $175 a month.

And even though Novartis does provide some help to the very poor,

Novartis said about 16,000 Indian patients received Glivec free under the company’s assistance program.

that certainly leaves a large number of people who either cannot afford the medicine or who are impoverished by trying to buy it.  So the advice here to drug companies is this.  Try and be a little more sensitive to the needs of your customers.  It will go a long way in getting you what you want.