How Paragraph IV Filings and ANDA Effect Pharmaceutical Patents
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.
How ANDA’s Effect Pharmaceutical Patents
For US patents, however, there exists an Achilles heel in patent protection: the paragraph IV certification and the Abbreviated New Drug Application (ANDA) process. In 1984, Congress enacted The Drug Price Competition and Patent Term Restoration Act, commonly referred to as the “Hatch-Waxman Act.” This legislation introduced a framework of rules and incentives for both brand-name and generic pharmaceutical companies to engage in patent challenges.
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.
ANDA’s are how generic drug companies gain approval for generic drugs and allow them to avoid having to complete their own costly trials, instead only having to show that their generic form shares “bioequivalence” with the branded drug under patent protection.
Why Generic Drug Companies Utilise AND to Challenge Patents
A significant aspect of the Hatch-Waxman Act actively promotes generic pharmaceutical companies to contest patents. When a generic company submits its Abbreviated New Drug Application (ANDA) with a Paragraph IV certification and successfully wins the ensuing legal battle, it is awarded a 180-day period of exclusive market access.
The obvious benefit of this is sales and revenue that can’t be contested by other generic drug companies, thanks to the exclusive market access. This method can prove to be profitable if there is a large volume of sales, since a costly clinical trial process wasn’t conducted by the generic drug company.
What is a Paragraph IV Filing?
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
- 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.
The Impact of ANDA and Paragraph IV Filings on the Pharmaceutical Industry
The potential impact of ANDA and paragraph IV filings potentially leaves millions of dollars at stake in revenue from sales for the generic companies. In addition to this, it also leaves branded drug innovators more vulnerable, as protecting their sales monopoly and avoiding potential loss of their intellectual property is now much more difficult.
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 our article discussing how patents are the lifeblood of the pharmaceutical industry.
Minesoft Can Help You Protect Your Pharmaceutical IPs
With how serious ANDA and paragraph IV filings can be, it is crucial to stay on top of patents in the pharmaceutical industry and make sure that you keep your own IP protected. Minesoft can give you access to powerful tools such as ChemX and Minesoft Origin, which allow you to search for and summarise millions of patents within the pharmaceutical industry.
You can use this information to stay ahead of the competition, and make sure your IP strategy is as informed as possible.
For more information on how Minesoft’s leading patent solutions can support your team, contact us today.