Insights into Editorial: Biologics, patents and drug prices

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Insights into Editorial: Biologics, patents and drug prices


 

Context:

Pharmaceutical R&D is an expensive, time consuming and uncertain process that may take many years to complete. The useful new drugs are patented, protecting them from competition and allowing them to charge high prices. When the patent ends, other companies are allowed to supply the previously patented drug. These are known as generics. The prices of generic drugs are much lower than the prices of in-patent drugs.

However, Pharmaceutical companies through ever-greening continue to seek extra patents on variations of the original drug. Such is the case with the world’s best-selling prescription drug, Humira, continue to grow even after the expiry of the patent over its main ingredient, adalimumab, and a biologic used for the treatment of arthritis by Secondary Patents.

The U.S. recognises and encourages secondary patents. India, however, does not. India’s rejection of secondary patents has kept blockbuster medicines affordable for many.

What is ‘Blockbuster Drug’

A blockbuster drug is an extremely popular drug that generates annual sales of at least $1 billion for the company that sells it. Examples of blockbuster drugs include Humira and Lipitor.

Blockbuster drugs are commonly used to treat common medical problems like high cholesterol, diabetes, high blood pressure, asthma and cancer.

Pharmaceutical companies through ever-greening continue to make profits by seeking extra patents on variations of the blockbuster drug.

How does ever-greening works?

Patents offer their owners market exclusivity for a limited period of time. For medicines, this exclusivity should last as long as the primary patent — which relates to the active pharmaceutical ingredient (API) of the medicine — is in effect, typically 20 years. The end of patent exclusivity will reduce the drug prices drastically.

However, pharmaceutical companies find new ways to postpone their exclusivity by filing secondary patents making small changes to an original drug with a new formulation, a dosage regimen, or a new method of administering the medicine. This practice is called ever-greening.

Ever-greening of drugs is not accepted in India

Patent holder attempts exploit the loopholes in patent laws and related regulatory processes in order to maximize their monopoly.

In India, couple of years ago, Swiss company Novartis filed a new patent on its drug Glivec, a drug used to fight leukaemia. But Supreme Court refused to grant Novartis a patent for a new version of its cancer drug as the drug was not substantially different from original one.  SC alleged new drug Glivec was only a ‘beta-crystalline’ form of the already existing cancer drug Imatinib. This has reduced the cost of drug from 1.6 lakh rupees to 11 thousand rupees.

Likewise, Spiriva, a medicine for asthma, enjoys patent protection until 2021 in the U.S., largely due to secondary patents. All of these secondary patents were rejected in India. As a result, while the monthly cost of the medicine in the U.S. is over ₹19,100, it costs a mere ₹250 in India.

India’s patent law also does not accept Ever-greening of drugs.

Indian Patent Act

Majority of rejected pharmaceutical patents at the Indian Patent Office have sought protection in the form of secondary patents for blockbuster medicines.

Indian patent law helps thwart ever-greening practices by pharmaceutical companies. This dramatically expanded access to medicines for important health problems such as cancer, AIDS, asthma and cardiovascular diseases.

The basic principle of the Patent Law in our country is that patent is granted only for an invention which must be new and useful.

Major innovations in Indian patent law:

As per Section 2(1)(ja) of the Patents Act, the product in question must feature a technical advance over what came before that’s not obvious to a skilled person. Because secondary patents for pharmaceuticals are often sought for trivial variants, they typically fail to qualify as an invention.

Section 3(d) necessitates a demonstration of improvement in its therapeutic efficacy. The provision also bars patents for new uses and new properties of known substances. In case of Novartis, Glivec was just a new form of a known substance, imatinib, and therefore the patent for Glivec was rejected under section 3(d) of the Patents Act.

Section 3(e) ensures that patents for combinations of known substances are allowed only if there is synergistic effect.

Section 3(i) ensures that no exclusivity can be claimed over methods of treatment.

Together, Sections 3(d), 3(e) and 3(i) have been instrumental in rejecting hundreds of secondary patents for pharmaceuticals.

Does Indian Patent act extend to Biologics?

A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. A substance that is made from a living organism or its products is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies and vaccines. These are new big players in the therapeutics marketplace.

Indian Patent Act provisions also extend to biologics as biologics are no stranger to the lure of secondary patenting for extending patent terms.

For instance, a quarter of the secondary patents for Humira, a biologic, are directed towards new uses and methods of treatment. Thanks to the provisions in the patent law, Humira enjoys no patent protection in India, since AbbVie Company restricted their Indian filings to only cover their secondary patents.

Conclusion

Blockbuster medicines are crucial to the success of public health. But they have been gamed, and rendered inaccessible to the people and governments who need them. In order for these medicines to be accessible, there is a need to enact strong standards to filter out bad patents.