Flexibilities Patents (Amendment) Act 2005 By S Sumbhate & Dr S Nayak


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Flexibilities: The Patents (Amendment) Act, 2005:

Flexibilities: The Patents (Amendment) Act, 2005 Sandip Sumbhate Dr. S. Nayak Associate Professor Principal & Professor sumbhate@gmail.com principal.bcp@gmail.com BANSAL COLLEGE OF PHARMACY, BHOPAL www.bansalpharmacy.com

PowerPoint Presentation:

The Top 10 Pharmaceutical Companies Within India 1. Ranbaxy Laboratories 2. Cipla 3. Dr Reddy's Laboratories 4. Sun Pharmaceuticals 5. Nicholas Piramal 6. Zydus Cadila 7. Biocon 8. Glenmark Pharmaceuticals 9. Wockhardt Ltd 10. Orchid Chemicals

PowerPoint Presentation:

Value of API production and export by major API-producing countries, 2011. Country Total API production Generic API production Total API exports Italy $3,200m $2,450m 99% Spain $1,020m $820m 90% India $2,000m $1,820m 75% China $4,400m $4,200m 77%

Exceptions to Patentability:

Exceptions to Patentability Section 3(d) 1.Prohibits patent to mere discovery of new form of a known substance without the enhancement of the known efficacy of substance. Salts, esters, polymorphs, metabolites, isomers, complexes.

Compulsory Licensing:

Compulsory Licensing Section 84(1) 1.Allows any person for grant of compulsory license at any time after the expiration of three years from the date of grant of patent. Section 92a(1) 1.Provides compulsary license for manufacture and export of patented pharm. products to any country having insufficient mfg. capacity.

Mailbox applications:

Mailbox applications Section 11(A) 1.Safeguard Indian generic drug manufacturers to continue marketing the patented product by giving reasonable royalty to patentee.

Opposition to Patent:

Opposition to Patent Section 25(2) 1.Pre-grant opposition 2.Post-grant opposition For Pre-grant, six months period has been introduced for making representation from the date of publication.


Publication Section 11(A) 1.Prescribes initial publication requirement. This prevents use of data by other companies on pre-patent information. 2.Avoids publication of the complete specification available to public.

Data Exclusivity:

Data Exclusivity India has not introduced provisions pertaining to data exclusivity whereby generic manufacturers can use test and clinical data submitted by patent applicant to national health authority for obtaining marketing approval of new drug.

Bolar provision:

Bolar provision Section107(a) Introduces many limited exceptions to ptntee’s exclusive rights under article 30 of TRIPS. With this, GDM can produce or import patented drugs for the purpose of devlopment and submission of information for regulatory trials.

Parallel Imports:

Parallel Imports Section 107A(b) Allows import of patented medicines sold abroad without the consent of the owner and keeps out of the purview of infringements of patent rights.

Exceptions for educational purpose.:

Exceptions for educational purpose. Section47(3), Addresses experimental use of patented invention, solely for the purpose of research or education, under the name of “ imparting of instructions to pupils”

Impact on health consumer.:

Impact on health consumer. The amendments in the act could enable India to continue making drugs available at cheap prices to health consumers . The effective use of the compulsory licensing provisions could result in continued domestic access to medicines at cheap cost.

PowerPoint Presentation:

Thank You Sandip Sumbhate Dr. S. Nayak Associate Professor Principal & Professor sumbhate@gmail.com principal.bcp@gmail.com BANSAL COLLEGE OF PHARMACY, BHOPAL www.bansalpharmacy.com

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