CMAJ Drug Patents: the Evergreening Problem

CMAJ News

s any would-be inventor enough of an improvement to warrant have never been any patents for knows, coming up with some- patent protection. Gleevec there,” he says. A thing the world has never seen But India’s trade and industry min- Furthermore, argues Herrling, before can be tough. Tweaking some- ister, Anand Sharma, has defended the India’s concept of evergreening is something old and calling it new, what overreaching. According on the other hand, is consider- to its patent law, a new ver- ably easier. sion of an old drug must In the pharmaceutical trade, demonstrate improved effi- when brand-name companies cacy to merit a patent monop- patent “new inventions” that oly. But what if the new prod- are really just slight modifica- uct improves patient safety? tions of old drugs, it’s called Or reduces adverse effects? “evergreening.” And it’s a prac- Or increases adherence? tice that, according to some “I agree that if it doesn’t who have looked into it, isn’t provide the slightest advan- doing a whole lot to improve tage to patients, it does not people’s health. deserve protection. You can’t “Typically, when you ever- merely take a molecule and green something, you are not paint it a different colour,” looking at any significant ther- says Herrling. “But anything apeutic advantage. You are you do to a molecule, as small looking at a company’s eco- as it could be, if it results in a nomic advantage,” says Dr. clear medical advantage for Joel Lexchin, a professor in patients, then it should be the School of Health Policy protected.” and Management at York Uni- The problem is, these versity in Toronto, Ontario. modified drugs don’t offer “The response from the enough of an advantage over brand side is that they are try- generic versions of the origi- ing to protect their markets so nal molecules, says Jim they can further invest in Keon, president of the Cana- R&D [research and develop- dian Generic Pharmaceutical ment]. And even if they make Association. So the sophisti- a modification to a drug, doc- cated lifecycle plans brand- tors are still quite able to pre- name companies have for scribe the generic version of their products — rolling out the older product. Having said new versions when patents that, the brand-name compa- 2013 Thinkstock © near expiry — are created pri- Whether a new drug that merely modifies an existing patented nies put an awful lot of money molecule deserves its own patent depends on the therapeutic marily to help bottom lines into marketing the newer ver- advantages it offers. rather than patients. And the sion, and that marketing is argument that this is neces- designed to affect what doctors do.” decision, and was quoted by Agence sary to earn enough money to reinvest Evergreening has been a hot topic of France-Presse as saying it was in new R&D doesn’t hold much weight, late because of the recent ruling by “absolutely justified under the law” suggests Keon, if that research only India’s Supreme Court to refuse to grant and that India’s patent law “does not results in more “me-too” drugs. Swiss pharmaceutical company Novar- accept evergreening.” “They have to recoup R&D costs, tis a patent for a new version of its can- In the case of Gleevec, though, this yes, but the question is: Is it useful cer drug Gleevec (imatinib mesylate), or makes no sense, according to Paul R&D? If the R&D is just to tweak a Glivec, as it’s known in some countries. Herrling, chair of the board of the product to get more monopoly pro- Novartis claims the drug is more easily Novartis Institute for Tropical Dis- tection without really providing an absorbed into the blood and, consider- eases in Singapore. “There can be no improved medication, then maybe it ing it is used to fight leukemia, that is evergreening in India because there doesn’t deserve a patent,” says Keon.

“Generic drugs are equivalent to drug to market carries Vegas-like odds, mental,” adds Kierans. “The patent sys- brand-name drugs. They have the same he suggests, and putting up barriers to tem, all the way back to the Statute of medicinal ingredients. A me-too drug, protecting intellectual property will Monopolies [a British act passed in in some ways, is just a sophisticated only discourage innovators from taking 1624], recognizes that it is good for the generic drug. It is just tweaked a bit to those risks. economy to encourage people to take claim it as a new invention. Should they “A week doesn’t go by when you these risks and to bring new things for- get patents?” don’t open up a newspaper and see ward.” — Roger Collier, CMAJ Well, if that tweak advances medical that some company’s drug got wiped science in any way, then the answer to out in a phase-3 clinical trial, and by CMAJ 2013. DOI:10.1503/cmaj.109-4466 that question is “yes,” according to that time they had already sunk 800 Patrick Kierans, the global head of to 900 million bucks into that drug,” pharmaceuticals and life sciences for he says. Editor’s note: This is the second of Norton Rose, an international law firm “You are talking about extremely a three-part series on patents. Go to with offices worldwide and expertise in high risk to develop new therapies and cmaj.ca to read the first article: “Drug pharmaceutical IP (but not involved in compounds. Some are going to be revo- patents: innovation v. accessibility.” the India legal battle). Bringing a new lutionary. Some are going to be incre-

E386 CMAJ, June 11, 2013, 185(9)