Press Release
March 27, 2007


Roxas Amendments consistent with US Appellate Court Decision on Norvasc

Senator Mar Roxas expressed victory over the recent decision of the United States highest appellate court invalidating the patent of Pfizer over amlodipine besylate, a hypertension drug under the brand name Norvasc.

He said the decision last week of the US Court of Appeals for the Federal Circuit is consistent with his proposed amendments to the Intellectual Property Code, or Senate Bill No. 2263, also known as the cheaper medicines bill.

The US Federal Circuits decision to invalidate the patent of Norvasc for obviousness also upholds one key principle in our bill, which is on the inventiveness or newness of medicine patents, he said.

It supports our position that the discovery of so-called new uses or new forms of existing drugswithout enhancing the efficacy of suchdo not deserve an extension of its patent life, he said.

Roxas said existing loopholes in the Intellectual Property Code had allowed multinational firms to have an extended hold over the patents of medicinesthe so-called ever-greening of patentsdenying generics manufacturers the opportunity to develop cheaper versions of said drugs.

Kung hindi naman talaga nagbago ang gamot o naiba ang bisa nito, bakit naman dapat pahabain ang buhay ng patent nito? Hindi tuloy makagawa ang mga lokal na manufacturer ng mga generic at mas murang gamot, he said. Ang pagbawal ng gawaing ito ay isa sa mga pangunahing layunin ng pagbabago sa Philippine Intellectual Property Code na nasa SB 2263.

On 22 March, 2007, a three-judge panel unanimously invalidated the patent of amlodipine besylate, referred to as the 303 patent issued in 1989. This, as Pfizer already had a previous patentreferred to 909 patent issued in 1982already disclosing amlodipine, but combined with a different salt with is maleate.

The Federal Circuit found that the superior property of amlodipine mixed with the salt besylate, compared to the previous amlodipine maleate, was not unexpected, thus, rendering the invention as obvious.

Roxas explained that for a product to deserve a new patent, it must involve an inventive step, which means that the invention is not obvious or not known to any person skilled in an artin the case of medicines, a chemistduring the date of application for the patent.


This means that if the so-called invention just results from the mere discovery of a new use, form or property of a known substancebut its efficacy is still the samethere is no inventive step, he said.

Among the Roxas Amendments in Senate Bill No. 2263 is a new provision specifying that there is no inventive step if the invention results from the mere discovery of a new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or, the mere discovery of any new use for a known substance or a known process unless such known process results in a new product that employs at least one new reactant.

Clearly, we are on the right track in our reforms to the patents and intellectual property rights of pharmaceuticals, Roxas said. The highest appellate court in the US has issued a decision in support of our position in SB 2263. We should thus not deprive the Filipino of the same legal coverage for more quality affordable medicines.

Other provisions of the proposed Roxas Amendments are: adoption of the early working doctrine, to allow generics manufacturers to study and develop generic versions of a drug before the patent expires; adoption of the international exhaustion principle to allow the parallel importation of medicines; and making government use of patented drugs more efficient and effective.

The amendments are compliant with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization.

The Senate has passed the bill on 3rd reading. The House is expected to pass its counterpart, House Bill 6035, when session resumes on June 4.

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