Intellectual property (IP) is a buzz word in today’s knowledge based era. The value of IP is enormous and ever increasing, especially in the field of pharmaceutical industry. Moreover, thanks to computers and internet, which make transfer of information even faster than speed of light. The advent of e-communications has brought everyone on global level and the competition in each filed of technology is fierce.If we look at various patent related cases, which are filed in all Federal District Courts of USA, we would note that from June 01, 2007 to June 26, 2007, at least 224 new cases have been filed. The number is mind-boggling. Statistically it is approximately 10 new patent related litigations per day! A list of few of these cases, mainly related to Pharmaceutical field is given in Table – 1. By virtue of these litigations, multimillion-dollar molecules such as Oxaliplatin, Depakote are under generic attack. The battle of Sertraline is special as it involves fight of generic companies with each other.
The US generic market is definitely a lucrative option for generic companies and beyond any doubt, the provisions of Hatch-Waxman Act has catalyzed early generic entry. In fact all major life savings drugs have seen an early entry by the provisions of Hatch –Waxman in USA. Further, one should thank to the apex Court of USA, for raising the standard of obviousness in USA recently through a judgment in KSR case.
Therefore, patent battles would continue to drive pharmaceutical market in USA.
1 comment:
The U.S. patent system historically has provided the necessary incentive for the discovery and development of new drugs. However, due to the pressure for ever increasing profits at pharmaceutical companies, the U.S. patent system is being abused as never before. Pharmaceutical companies - brand name and even generic companies - are frequently pursuing patent protection for "inventions" which do not merit the grant of a 20 year monopoly. They pursue these patents with one goal in mind - to keep competition out of the marketplace for as long as possible, irrespective of whether the patent has any merit. For example, Schering's licensor Sepracor recently obtained a patent claiming a pharmaceutical composition containing 0.1 to 10 mg of desloratadine (U.S. Pat. No. 7,214,683). The USPTO granted this patent even though the prior art (U.S. Pat. No. 4,659,716) taught a "typical recommended dosage regimen is oral administration of from 5 to 100 mg/day, preferably 10 to 20 mg/day, in two to four divided doses to achieve relief of the symptoms." This type of patent is the reason why the U.S. patent system is under attack by the Supreme Court and Congress. It creates unnecessary litigation, solely for the purpose of delaying generic companies from entering the marketplace. Patents should be granted for significant contributions to society, not dribble such as this.
Post a Comment