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The pharmaceutical industry is one of the most potential industry which has huge profit margins. Extensive growth and knowledge are required with frequent changes for better technology and results. Starting from early to the final stage there are gigantic chances of the product’s to face success or failure. Apart from these challenges, a large amount is invested to launch products in the market. In this entire process starting from drug designing to manufacturing, IPR plays a vital role. Intellectual Property Rights today are the most strategic and powerful asset of all large and Multinational Companies throughout the world, providing continued global market, economic dominance, and profitability. Multinational companies decide mergers and acquisitions on the basis of Intellectual Property Assets. All companies irrespective of their size get their technology Patented/Registered which makes their assets safe for a trading license, joint R&D/Production ventures, recognized globally.
Extension of Patent Life by Making Modification in Drugs
Pharmaceutical companies are playing smart by making slight modifications to their existing drugs in order to extend a patent life span which has resulted in calls for the government to not recognize process methods for patenting and allowing only molecular patents.
Pfizer’s Caduet is a perfect example, It is a pill used for the treatment of heart disease. Caduet is a simple combination of the blood pressure drug amlodipine besylate (marketed as Norvasc) and the cholesterol drug atorvastatin calcium (better known is Lipitor). Pfizer developed both Norvasc and Lipitor, with Lipitor holding the post of top-selling pharmaceutical in the world for several years. Pfizer’s patent on Norvasc and Lipitor expired in 2007and 2011, respectively, but due to Pfizer’s existing patent on the molecules, no other manufacturers could produce a combination medication containing the molecules. Caduet conveniently entered the market in 2004.
Another example is Prilosec, when the patent for Prilosec was near expiry, AstraZeneca in order to maintain the monopoly of the blockbuster drug Prilosec launched Nexium which was the same drug with minor changes in design and color.
Pharmaceutical R&D is an expensive and time-consuming process that may take 8-10 years to complete. Companies are well aware of the time consumed in the review and approval process by regulatory bodies before a new drug gets approval for marketing. So in order to recoup the considerable time and resources invested in the drug development and approval process, the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies.
There are many official and unofficial methods to extend the term of a patent beyond 20 years wherein,
Official methods include provisions by some regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate (European Medical Agency), whereas
Unofficial methods include altering or reformulate the existing compound to obtain a new patent by utilizing polymorphism, creating combinations, stereo-selective/chiral switches, conversion to NDDS, OTC switching, authorized generics, etc. This article aims at highlighting the strategies used by Pharma giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the regulatory provisions in different countries to check these practices.
However, the Pharmaceutical Association of Malaysia (PhAMA) is arguing with the government that modifications do make a difference because different salts carry different pharmacological properties which put forth different effects on patients. Moreover, different salts are patented alone as each carries different properties altogether.
As per PhAMA, nobody is able to predict which salt form is able to provide the desired therapeutic effects and both innovative and generic pharmaceutical companies do file their own patents which are further granted on the basis of novelty, inventive steps, and industrial applicability.
After discovering a compound and registering it as a patent, a drug company has 20 years of protection for the patent where it will then carry out pre-clinical trials, and Phases 1 to 3 clinical trials, all of which may take 10 to 12 years. After the trials, the company submits the results for product registration and the authority will evaluate the document.
Usage of Patented Technology in the Pharma Industry
Pharmaceutical companies are usually at high-risk as once a drug has been successfully created, it is susceptible to being copied by a third party through reverse engineering as pharmaceutical compounds can be easily imitated once they have been discovered hence, a patent protects the rights of the inventor and invention. If third-party voids their rights, they are bound to undergo Legal consequences.
Chin says that a strong IP regime is critical for Malaysia to boost its competitiveness, especially to attract foreign direct investment while at the same time encourage technological advancement and innovation.
Since drug development carries unknown risks and extensive research and development which consumes several years. For example, a pharmaceutical company spends some year’s time getting the Federal Drug Administration (FDA) approval for a drug. This means that when the drug comes up in the market, the patent could be good for only a few more years.
Some have considered whether it would be sensible to allow a solid 15 years of patent life after the drug has been cleared by the FDA. However, this is a complicated solution. Presently, drug companies already try to extend the patent life of their drugs as much as they can.
Most of the countries provide a 20-year exclusivity for a patented drug, so that innovator firm remits to undue practices such as evergreening in order to recover heavy costs incurred by them. These practices have become too aggressive with passing time.
Cooperative firms state to understand the pain of people and work for humanity, however, are not in any way humanitarian in their approach, even though they pose to be, their sole motive is to hold their monopoly in the market and increase the number of patents in their patent portfolios. To check this practice some countries have included certain provisions in their patent laws to extend the overall life of the patent so as to recover some of the time lost during regulatory processes, but in turn innovators firms have found loopholes in the laws and even started exploiting these official provisions.