PATENT INFRINGEMENT-A CASE STUDY OF BOLAR PHARMACEUTICAL INC VT

PATENT INFRINGEMENT-A CASE STUDY OF BOLAR PHARMACEUTICAL INC. VS ROCHE PRODUCTS INC.: 

PATENT INFRINGEMENT-A CASE STUDY OF BOLAR PHARMACEUTICAL INC. V S ROCHE PRODUCTS INC. PRESENTED BY- VISHWAMBHAR T. JOSHI DEPT. OF PHARMACEUTICAL ANALYSIS NIPER-AHMEDABAD

OUTLINE OF PRESENTATION: 

OUTLINE OF PRESENTATION INTRODUCTION CASE STUDY CONCLUSION

INTRODUCTION: 

INTRODUCTION Roche products Inc. is swiss multinational pharmaceutical company. Head quarter at Basel, Switzerland. The company introduced a class of traquilisers called benzodiazepines in 1957. First antidepressant drug iproniazide in 1956. The company is also credited for introduction of isotretinoin (for acne) and oseltamivir (for Bird flu).

Cont… : 

Cont… During 1960’s the company worked on developing substituted Benzodiazepines –a class of sleep inducing drugs, in order to prepare longer acting analogues. They ended up with – FLURAZEPAM. Roche obtained a patent on this novel substituted benzodiazepine and launched it under the brand name DALMANE. The patent was granted on 17 Jan. 1967 and was valid till 17 Jan 1984. The US patent no. 3299053.

Cont… : 

Cont… Bolar pharmaceuticals – a small US based generic drug manufacturing company, found that flurazepam had great sale and DALMANE had became a popular brand. Bolar decided to launch the generic version of FLURAZEPAM as soon as possible after expiry of Roche’s patent. Because the success of any generic product depends on How quickly it is brought in to the market after expiry of the patent.

Cont… : 

Cont… In early 1983, Bolar obtained 5 kg of flurazepam from a foreign manufacturer. With out waiting for patent to expire, Bolar formulated it in to capsules and started the stability , Dissolution rate and bioequivalence studies to generate Data required to file in FDA for generic product approval. Bolar intended to launch their product just next day after patent of DALMANE expires.

CASE STUDY: 

CASE STUDY Roche pharmaceuticals filed a case against Bolar in District Court for Eastern District, New York on 26 sep.1983. Roche pharmaceuticals said that as per rights granted under patent Act no one can make, use, offer for sale or import a patented invention. so Bolar has done infringement on their rights. Bolar used flurazepam in order to make it’s generic version ,so it was clear that there was economical intention behind there Experimental Use .

Cont… : 

Cont… Bolar pharmaceuticals argued and said that- “ suppose we start the bioequivalence studies after patent expiry, it will take time for studies and approval of the product by FDA. Say for eg . it will take 2 years. Mean while in that period also there will be monopoly of the patentee. Thus patentee will enjoy monopoly even after patent expires.”

Cont… : 

Cont… “ Govt. itself wants easy and cheap availability of all drugs as per policies adopted in Drugs and Cosmetic Act 1982. Launch of generic version quickly after patent expiry will help in reducing prices. So such use with a good faith is not an infringement”

Cont… : 

Cont… Court concluded that- “ As per Patent Act no one is allowed to USE the invention with the intention of business. Bolar pharmaceuticals infringed the rights of Roche Pharmaceuticals. So as per roche’s request of relief , the Data generated by Bolar during it’s study should be confiscated and destroyed and it will have to bear it’s loss by own.”

Cont… : 

Cont… At the same time on the basis of Bolar’s argument Court suggested American Congress to make provisions in this area and remove the policy conflicts between Drugs and Cosmetic Act and Patent Act. Shortly after this case, American Congress did passed a law permitting use of patented product in Experiments in order to obtain FDA approval data ( Drug price Competition And Patent Term Restoration Act 1984.) i.e. Hatch-Waxman Act.

INDIAN PATENT ACT: 

INDIAN PATENT ACT In May 2003 , Indian Patent Act was amended and new section 107 A was introduced. This provisions enables a generic manufacturer to use patented product to obtain marketing approval data though the patent has not been expired. This provisions are popularly known as Bolar Exemptions !

REFRENCE$: 

REFRENCE$ www.biotech.law.isu.edu.com www.knol.google.com www.law.harvard.edu www.wipo.int www.ptodirect.com