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We examine whether or not the medical product is protected by a basic patent, as well as if an application for supplementary protection has been filed in US. In cases where supplementary protection has been granted, we inform you of the duration of validity
We also process NDA and ANDA filings for US markets
As one of the most dynamic industries for innovation in the global market, the Life science industry is constantly spinning innovations and techniques into a variety of consumer reliable products. From life-saving devices to advanced medications that people use to enhance their lives, medical device use is pervasive in our society.
Glide Legal has the expertise to protect innovative life sciences IP. We specialize in NDA and ANDA and SPC filings with the Food and Drug administration. We also provide orange book search for Generic and New drug molecule.
Supplementary protection certificate (SPC) for medical products
An invention can be protected by a patent for up to twenty years from the date of filing. Patents for medical products, however, can be extended by up to five years with a supplementary protection certificate (SPC). SPCs are available within the EU and the basic patent must be in force in the member state in question, in order to obtain an SPC.
An SPC covers the active ingredient or combination of active ingredients in a medical product, as defined in the appropriate EC regulation. A certificate can only cover a single product. Different products can be the subjects of different certificates even if they are protected by the same basic patent. The certificate is valid from the date of expiry of the patent, and the duration of the certificate is determined from the date of filing of the basic patent and the first marketing authorisation within the EES. SPCs can also be granted for plant protection products in the same manner as for medical products.
The term “basic patent” refers to the patent which constitutes the basis for an SPC application. The basic patent protects either the product as such, a process for obtaining the product, or an application of the product.