The Indian Pharmaceutical Alliance (IPA) has demanded the Indian Government to take appropriate action against Hank McKinnell, chairman and chief executive, Pfizer for making statements amounting to slander and racial discrimination.

In a letter to Shyam Saran, foreign secretary, Ministry of External Affairs, Government of India, IPA said that the statements made by the Pfizer chief on the Ranbaxy-Pfizer Lipitor recent judgement from a US court, are slanderous and outright malicious aimed to denigrate Indian companies. The false and defamatory allegation had the potential to cause irreparable damage to the Indian pharmaceutical industry. The government should study the defamation and its consequences and should take steps to mitigate the damage to India and the Indian pharmaceutical industry. The issue should be taken up with the appropriate authorities in the US on two counts, slander and racial discrimination.

While referring to the US court decision in the Lipitor case, Hank McKinnell had said, "This is a big win for Pfizer. It is also a big win for medical Innovators. This should be a message for companies in India that do have important scientific capabilities that they should not steal others' innovations but they should create technology for themselves," as reported in The Financial Times, US edition on 17th December 2005.

IPA noted that the statement is slanderous and outright malicious aimed to denigrate the Indian companies. The law suit related to filing of an application by an Indian company to market generic version of Pfizer's Lipitor (atorvastatin), is very much as per the US law (Annex-1) and does not in any way amount to 'stealing' as maliciously alleged in the statement. The Para IV challenge is a common practise and followed by many US and other global companies. However, by singling out Indian companies, the comment tends to be racist and tantamount to racial discrimination. Further by alleging that the US Court decision was a 'message to Indian companies not to 'steal others' innovations", Dr McKinnell has deliberately sought to distort the scope of the decision to imply that the legal proceedings were related to the stealing of Pfizer's innovations. Such statements are hindrance to improving bilateral trade and the commercial climate between the two countries, said IPA.

"It would obviously be hard for anyone to understand how a challenge to a patent, by following a process as per law could amount to 'stealing', particularly when a court of competent jurisdiction in the UK has held the equivalent patent invalid. By choosing not to refer to the UK decision, a reference which would obviously undermine his allegation and dilute the impact, Dr McKinnell has demonstrated that the defamation was deliberate and calculated to cause the maximum damage," noted DG Shah, secretary general, IPA in his letter.

Elaborating the legal background, he noted that the Food, Drug and Cosmetic Act (the Act) governs the approval of drug products in the United States. Section 505(j) of the Act, created as part of the Waxman-Hatch Amendments in 1984, established the process for approval of generic drug products through the filing of abbreviated new drug applications (ANDAs). The Waxman-Hatch Amendments were intended to balance the competing public policy goals of promoting innovation on the part of brand-name companies, while, at the same time, making lower priced generic products available to consumers as quickly as possible.

As a part of this process, innovator drug applicants are required to include in a new drug application (NDA), information regarding patents that claim the drug product that is the subject of the NDA. The US Food and Drug Administration (FDA) list the patent information as part of a publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations. A generic applicant must include in the ANDA, a patent certification as described in section 505(j)(2)(A)(vii) of the Act for each listed patent. The certifications must make one of the following statements: (I) No patent information on the drug product that is the subject of the ANDA has been submitted to the FDA; (II) that such patent has expired; (III) the date on which such patent expires; or (IV) that such patent is invalid or will not be infringed by the manufacture, use or sale of the drug product for which the ANDA is submitted.

The last certification referenced above is known as a paragraph IV (PIV) certification and indicates that the generic applicant intends to market the product prior to expiration of the relevant patents. Notice of the PIV certification must be provided to the patent owner, who may sue the generic applicant for patent infringement. If the generic applicant is sued, the FDA cannot approve the ANDA until the earlier of 30 months from the date on which the patent owner received notice of the PIV certification or until the generic applicant receives a favourable court decision.

In order to foster its policy goal of making generic products quickly available, the US Congress included section 505(j)(4)(B)(iv), which provides an incentive for generic manufacturers to file PIV certifications. If successful in its patent challenge, the first generic applicant to file a PIV certification may receive 180 days of marketing exclusivity during which time; the FDA cannot approve subsequently filed ANDAs for that particular drug.

It would obviously be hard for anyone to understand how a challenge to a patent, by following a process as per law could amount to 'stealing', particularly when a court of competent jurisdiction in the UK has held the equivalent patent was invalid. By choosing not to refer to the UK decision, a reference which would obviously undermine his allegation and dilute the impact, Dr McKinnell has demonstrated that the defamation was deliberate and calculated to cause the maximum damage.