Dosage regimen research; is it worth it?

09.05.2020

A recent UK Supreme Court decision calls into question whether biotech companies should continue to invest in dosage regime research. Optimising dosing regimens is undoubtedly beneficial to patients as it can improve efficacy profiles and reduce side effects. However, the required pre-clinical and clinical research represents a large capital investment which the availability of patent rights helps to justify. The Supreme Court decision in Actavis v ICOS Corporation [1] addresses the availability of patent rights for dosage regimens and therefore also the value of existing patents that protect such research.

The Court’s decision

The drug in question was tadalafil, a bestselling treatment for erectile dysfunction. Tadalafil is authorised for use by patients ‘on demand’ where it is administered a period of time ahead of its effects being desired or, alternatively, at a lower daily dose which provides all day coverage. The Court accepted that Eli Lilly had conducted extensive research into ascertaining the lowest effective dose of tadalafil which could be used for daily dosing by patients, and this result was not predictable in advance. However, the Supreme Court found that Eli Lilly’s discovery was a result of “…pre-clinical and clinical tests [that] involved familiar and routine procedures and normally progressed to the discovery of the dose-response relationship…”. The Court therefore found the patent invalid and revoked the right.

Why does it affect me?

In reaching its decision the Supreme Court considered the patent protection which is provided for dosage regimens more generally so is equally applicable to the biotechnology industry. In particular, the Court reaffirmed that while there was no reason why patents should not be granted for the results of new and innovate research into dosage regimens, these criteria are typically not met when determining appropriate dosage regimens. This was because the target of such research is largely pre-determined.

What can I do?

At first glance patents protecting dosage regimens, especially those resulting from standard pre-clinical and clinical testing required to bring a product to market, are vulnerable to be being rejected or revoked and will be valued accordingly. However, this may not always hold true. In particular:

  • The Supreme Court confirmed that the burden and the cost of research is a relevant factor when considering whether a patent right is available. The courts should take into account that from a policy perspective it is important to facilitate expensive pharmaceutical
  • A distinction can be drawn for research which is not routine or where the target of the research is not pre-determined. This may encompass, for example, additional research on established medicines already on the market or where the research is being conducted on a drug which, without proprietary information, would seem commercially unviable.
  • It is sometimes possible to file additional patent rights or amend existing patent rights so that issues with the patentability of dosage regimens can be avoided or mitigated. However this is best assessed on a case-by-case basis.

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[1] Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15 – Bristows’ full legal analysis of this decision can be found at: http://patentblog.kluweriplaw.com/2019/03/27/the-supreme-court-decision-in-actavis-v-icos/ 

Adrian Chew

Author