- Patenting Biologic Drugs
- Pharmaceutical Patents and Generic Drugs
Numerous biologic patents are going to expire soon. As with the pharmaceutical or “small molecule” drug market, the opportunity of generic or follow-on drugs now are available for biologics. Biologics typically include peptides and proteins, especially monoclonal antibodies, in addition to vaccines. Although biologics are presently controlled underneath the Public Health Service Act, three different bills happen to be introduced that will impact follow-on biologics. Unlike conventional pharmaceuticals where bioequivalent chemicals are utilized, biologics use living cells. This raises problems with biosimilarity since, whether or not the original cells can be found, phenotypic variations and variations in primary amino acidity sequences allow it to be hard to use the conventional perception of biosimilarity.
In the Trojan viruses Law Offices, our gifted La Pharmaceutical and Biologic patent attorneys comprehend the issues and challenges pharmaceutical and biologic patents present. Our understanding of bio-technology and also the techniques and procedures utilized in bio-scientific research means we’re distinctively positioned to counsel and offer clients in matters associated with pharmaceutical and biologic patents and follow-on drugs.
To schedule a scheduled appointment and discuss the way we will help you, contact the Trojan viruses Law Offices today.
Patenting Biologic Drugs
Under 35 U.S.C.A. § 112, pharmaceutical composition claims for biologics should be based on a disclosure that will allow someone acquainted with the skill to produce the biologic under consideration. The problem here is if someone acquainted with the skill can really produce a follow-on biologic once the cell line used hasn’t been deposited or once the processes involved aren’t fully disclosed. When the processes necessary to produce a biologic aren’t disclosed, this could appear to invalidate the “quid pro quo” nature from the patent grant.
While this can be a problem for normal pharmaceuticals, within the situation of biologics the problems will vary. Disclosure for biologics will probably involve descriptions of methods genes are isolated to be able to produce the quantity of protein needed. If cell line is deposited, these details could be utilised by foreign competitors. Our IP attorneys in La can review these problems along with you and do something to make sure your patent offers the optimal quantity of protection without running afoul from the quid pro quo nature of the patent grant.
Pharmaceutical Patents and Generic Drugs
Generic medicine is bioequivalent agents where ingredients are similar and inactive ingredients different. In the Trojan viruses Law Offices, our attorneys evaluate the patent applying generic drug manufacturers to guarantee the patent involved meets the stipulations needed for bioequivalence.
To learn more regarding our practice and just how we will help you, contact pharmaceutical and biologic patent attorneys in the Trojan viruses Law Offices today.