The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act", is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah.
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act.as a result of which the would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic.
Although it has been a boon for the small players in the market and saved people from emptying their bank accounts fully......there are some loopholes which we cannot just ignore!! They require some action to be taken and the FDA needs to amend the act to prevent the discrepancies observed today......"
The major loopholes in the act which have been explored by the brand name manufacturers to gather full advantage are:
1. Warehousing patents and frivolous lawsuits:
The Buspar case (BMS vs Mylan Pharmaceuticals) relates to both the Para III and Para IV certifications.
Bristol Mayer Squibb (BMS) Co had patent number 4182763 with a primary claim of buspirone as an anxiolytic agent. This patent expired on July 21, 2000, and Mylan Pharmaceuticals filed a Para III certification and obtained a tentative approval to market the generic version of the drug not before July 22, 2000.
However, BMS obtained another patent just 12 hours before the expiry of its first (763) patent claiming the active metabolite of buspirone as responsible for the anxiolytic effect.
The patent was for the combination of the chemical compound in the drug with stomach acid which was produced naturally.
The patent was listed in the Orange Book and as per the laws was informed to Mylan that the ANDA was incomplete and needed justification that its generic version of buspirone would not infringe upon the new patent.
Mylan in anticipation filed a Para IV certification under the Hatch Waxman Act which led to the patent infringement lawsuit against Mylan immediately halting the final market approval of the generic and the associated stays and delays.
FDA could not approve the marketing of the generic that Mylan had already loaded on trucks for shipment.
It is also referred to as Evergreening or Warehousing of patents. An innovator may patent multiple attributes of a product (may be color, manufacturing process or the chemicals produced when the drug is ingested in the body) and keeps on adding patents in the Orange Book, essentially forcing the generic to hose between waiting for the patents to expire or file a Para IV certification which brings along the risks of litigation and associated costs and delays.
The provision of filing a patent infringement lawsuit gives the brand name manufacturer at least an additional two and a half years of product monopoly has resulted in a wave of such lawsuits.
2. Maneuvering the six month Generic Exclusivity
The practices commonly referred to as ‘Sweetheart deals’ allow the first generic manufacturer and the innovator to enter into an agreement and to have a control when to introduce the generic.
This would not trigger the 180 days generic exclusivity period offered to the first generic and the FDA is bound not to approve another generic until the 180 day generic exclusivity period perishes.
This will suspend the competition for an indefinite period of time. This extended brand name monopoly allows the brand name and the generic manufacturer to share the financial awards keeping other generic competitors in an indeterminate state.
Case study:-
Cardizem CD (diltiazem hydrochloride) is a prescription drug manufactured by Hoechst-Marion Roussel, Inc. (“HMRI”) that is used to treat angina and hypertension.
The Cardizem litigation arises primarily out of an interim “settlement” of patent infringement litigation brought by HMRI against Andrx Pharmaceuticals, Inc., the first ANDA filer for Cardizem CD.
In settling the patent infringement litigation, HMRI and Andrx allegedly agreed that, beginning upon final FDA approval of Andrx’s generic product, HMRI would pay Andrx $10 million per quarter not to enter the market with its generic product until the conclusion of the patent litigation.
The intention of this article is to bring to notice the exploitation of the loopholes of Hatch Waxman Act by several multinational companies. This in turn affects the common people as the generic products could not enter the market early and deprives them of the monetary relief (which they would be enjoying with generics). Its time to take action.....USFDA!!
( Several more cases have been observed.refer other cases from: Saigal N. et al, USFDA Generic Approval Process,Indian J.Pharm. Educ. Res.; Jul-Sept, 2009:232-238. available from the internet at:http://www.ijperonline.com/archives/IJPER_43_3_2009.pdf)
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