'Evergreening' a blot on cheaper drugs law

TULOY NA: President Gloria Arroyo confirmed yesterday her plan — reported last Sunday in Postscript — to run for the congressional seat in the second district of Pampanga now held by her son Juan Miguel (Mikey).

“After much contemplation, I realized I am not ready to step down completely from public service,” she said over state radio. “Gaya ng alam ninyo, hiniling din ako ng mga mamamayan ng aking tahanang distrito sa Pampanga na manatili sa buhay publiko. So after much soul-searching I have decided to respond affirmatively to their call.”

Despite her denying it, her candidacy is widely linked to moves to amend the Constitution to shift to a parliamentary setup as well as to speculation that she is looking for protection from prosecution after she loses presidential immunity.

Her running locally will reduce the issues to a political question that only the people in her home district can answer. If they want her to represent them in the Congress, there is hardly anything the rest of us can do.

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PATENT TRICK: The noble intentions of the Cheaper and Quality Medicines Act (RA 9502) can be frustrated by “evergreening,” the practice of adding minor or token changes to an old drug and registering it as a new medicine under a new patent.

“Evergreening” can be used by the medicine’s inventor to block the production of generics. It perpetuates his exclusive hold on an expensive drug covered by a patent that is periodically renewed so the drug cannot be duplicated.

I looked into this practice after readers complained that makers of some important medicines have been resorting to “evergreening” and to pressure tactics in blocking alternative drugs that are much cheaper but just as effective.

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CHOLESTEROL: One of the drugs cited was Lipitor (atorvastatin), a member of the drug class known as statins. It is used for lowering blood cholesterol, stabilizing plaque and preventing strokes.

Atorvastatin was first synthesized in 1985 by Bruce Roth while working at Parke-Davis Warner-Lambert Co. (now Pfizer). In 2008, Lipitor chalked up sales of $12.4 billion worldwide. I have no Philippine sales figures.

After government price controls were imposed recently, Lipitor tablets are now being sold at the reduced prices of P34.45 (for 10 mg), P39.13 (20 mg) and P50.50 (40 mg).

Over the objections of Pfizer, United Laboratories produced a much cheaper generic version marketed as Avamax. Its prices are around 30 percent lower: P25 (10 mg), P30 (20 mg) and P35 (40 mg).

There are two other companies selling their generic versions of atorvastatin, one of which is Innogen.

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PATENT ISSUES: Pfizer lawyers have written drugstores threatening them with legal action if they sell generic alternatives. But while Mercury Drug stopped selling Avamax, other drugstores (e.g. Watsons, Rose, South Star, Negros, MedExpress) continue to sell it.

The controversy revolves around the Pfizer patents. Unilab challenged before the Intellectual Property Office what it said were “invalid and frivolous” patents that have disadvantaged millions of Filipinos by depriving them access to life-saving drugs.

Pfizer has asked the IPO for more time to answer. Separately, it filed a complaint for patent infringement and prayed for an injunction with the Makati Regional Trial Court.

Btw, Unilab honors several licensing agreements with existing and valid patent holders, including Pfizer with respect to another drug, for which it pays royalties.

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PUBLIC INTEREST: The Food and Drug Administration appears to be out of the picture since its function is just to issue a Certificate of Product Registration for drugs, which it has done for Avamax.

The real battlefield appears to be the market. Given all the facts, the public should be able to make an informed decision as to what medicine to buy and where.

Long burdened by expensive drugs, the people should be given maximum access to cheaper but effective alternatives. This is precisely one of the objectives of RA 9502.

Pressuring Mercury Drug to stop selling Lipitor generics is unfortunate as the chain controls some 80 percent of the market.

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MONOPOLY: For a new discovery to be patentable, it must be novel and inventive. While the patent system seeks to reward and protect inventors, there is no such thing as perpetual monopoly.

The patent holder’s privilege is limited to only 17 years under the old law, and 20 years under the new statute. When the period expires, or is abut to, others are allowed to use the invention.

But an inventor is sometimes able to hold on to his intellectual property indefinitely by inserting later a minor element or modification and passing off the result as a new invention deserving a new patent. This is “evergreening.”

Patent abuse has resulted in high prices of essential medicines, because the inventor’s extended monopoly prevents the entry of alternative and more affordable drugs. It prevents competition that can drive prices down.

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FASTER ACTION: In the interest of the public, especially patients needing cheaper medicine, the IPO and the courts should rush deciding the case, resolving among other issues if the patent for Lipitor is indeed invalid and frivolous.

If the IPO and the courts determine that the patent is indeed novel and inventive and not a mere attempt at “evergreening,” its exclusivity must be upheld and protected.

But if it is found to be flimsy and frivolous, others should be allowed to duplicate it and sell generic versions at a much reduced price. The case can then become a precedent in resolving similar patent disputes.

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