Paragraph IV filings, generic drugs and Big Pharma

In April 2017 Minesoft was pleased to support the Raconteur Intellectual property supplement available in The Times newspaper. Among the covered articles was a breakdown on the changing face of the pharmaceutical sector with respect to Intellectual Property.

2016 was a difficult year for pharmaceutical patents, with patent expiration resulting in the loss of sales in excess of $125 Billion across the year.  Patenting is vital for the pharmaceutical industry, allowing a company to hold a functional monopoly on their property to recoup the costs of R&D and the investment needed to bring a drug to market. Crucially, pharmaceutical patents are the only category in which an patent term extension may be granted to compensate for the regulatory review period which involves two phases: clinical testing and regulatory approval. A maximum of 5 years extension can be obtained, depending on the time taken for the two phases of approval, and allows the company an additional period to profit from their invention and fund future research and investment.

For US patents however there exists an Achilles heel in patent protection: the paragraph IV certification and the Abbreviated New Drug Application (ANDA) process. ANDA’s are how generic drug companies gain approval for generic drugs and allows them to avoid having to complete their own costly trials, instead only having to show that their generic form shares “bio-equivalence” with the branded drug under patent protection.

A paragraph IV filing is a subset of an ANDA application, specifically covering a filing where the generic applicant is asserting that the patent they are targeting is i) invalid, ii) not infringed by their product or iii) not enforceable as written. Once an ANDA is filed, the patent holder has 30 days to respond and bring a counterclaim against the generic company. With millions of dollars at stake both for the generic companies (in revenue from sales) and the branded drug innovators (protecting their sales monopoly and avoiding potential loss of their intellectual property) paragraph IV filings are deadly serious to the US pharmaceutical sector and therefore to global health, as the US continues to lead the field in the number of new chemical entities invented annually worldwide.

Find out more in the article titled ‘Patents are the Lifeblood of Pharmaceuticals’ here.