A number of biologic patents are set to expire in the near future. As in the pharmaceutical or “small molecule” drug market, the potential for generic or follow-on drugs now exists for biologics. Biologics typically include peptides and proteins, especially monoclonal antibodies, as well as vaccines. Although biologics are currently regulated under the Public Health Service Act, three different bills have been introduced that would impact follow-on biologics. Unlike conventional pharmaceuticals where bioequivalent chemicals are used, biologics use living cells. This raises issues of biosimilarity since, even if the original cells are available, phenotypic variations and differences in primary amino acid sequences make it difficult to apply the conventional notion of biosimilarity.
At the Trojan Law Offices, our talented Los Angeles Pharmaceutical and Biologic patent attorneys understand the issues and challenges pharmaceutical and biologic patents present. Our knowledge of bio-technology and the techniques and processes used in bio-medical research means we’re uniquely positioned to counsel and present clients in matters related to pharmaceutical and biologic patents and follow-on drugs.
To schedule an appointment and discuss how we can help you, contact the Trojan Law Offices today.
Under 35 U.S.C.A. § 112, pharmaceutical composition claims for biologics must be supported by a disclosure that would allow someone familiar with the art to create the biologic in question. The difficulty here is whether or not someone familiar with the art can actually create a follow-on biologic when the cell line used hasn’t been deposited or when the processes involved are not fully disclosed. If the processes necessary to create a biologic are not disclosed, this would seem to invalidate the “quid pro quo” nature of the patent grant.
While this may be an issue for regular pharmaceuticals, in the case of biologics the issues are different. Disclosure for biologics will likely involve descriptions of how genes are isolated in order to produce the amount of protein needed. If cell lines are deposited, this information could be used by foreign competitors. Our IP attorneys in Los Angeles can review these issues with you and take steps to ensure your patent provides the optimal amount of protection without running afoul of the quid pro quo nature of a patent grant.
Generic drugs are bioequivalent agents where active ingredients are identical and inactive ingredients different. At the Trojan Law Offices, our attorneys review the patent applications of generic drug manufacturers in order to ensure the patent involved meets the stipulations required for bioequivalence.
For more information regarding our practice and how we can help you, contact pharmaceutical and biologic patent attorneys at the Trojan Law Offices today.