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Genentech loses patent life for wet AMD blockbuster

Genentech loses patent life for wet AMD blockbuster

Industry news 01/04/2019

On 31 March 2020, The Court of Appeal of England and Wales published its unanimous judgement on Genentech, Inc (and Master Data Center, Inc) v The Comptroller General of Patents - [2020] EWCA Civ 475 in which it confirmed a High Court ruling deciding that Genentech could not correct a mistake made by one of its agents that would lead to the early expiry of a valuable Supplementary Protection Certificate (SPC).

The SPC in question, SPC/GB07/012, covers the monoclonal antibody fragment Ranibizumab (trade name Lucentis). Ranibizumab is an anti-angiogenic approved for the treatment of "wet" type age-related macular degeneration (AMD) - a common form of age-related vision loss. In 2019, global sales of Ranibizumab exceeded $3.9 billion.

The error in question was made by Master Data Center, Inc (MDC), who was employed by Genentech to attend to the payment of fees in connection with the above-mentioned SPC.

MDC, instead of applying for the maximum allowable term for an SPC, which would have expired in January 2022, mistakenly applied for a two-year term that would end on 2 April 2020.

Two separate appeals were filed by both Genentech and MDC against the original High Court ruling prohibiting the correction of this error.

MDC’s case relied upon Rule 107 of The Patent Rules 2007 which affords the Comptroller a discretion to rectify an "irregularity of procedure”. MDC claimed one such irregularity attributable at least in part to the Comptroller was the failure to notify Genentech they had not paid fees for the period of a maximum duration SPC. Furthermore, MDC claimed the IPO incorrectly indicated to Genentech and MDC that they could choose a duration of SPC that was shorter than that provided by the EU SPC regulations.

The Court of Appeal dismissed the arguments put forward by MDC. The shorter SPC period indicated in the relevant notice with a reduced fee, although non-typical, was deemed lawful and thus the comptroller was under no obligation to notify Genentech about a failure to pay fees for a maximum duration SPC.

Genentech’s case simultaneously presented several further grounds of appeal. Their counsel initially argued Rule 116(5) of The Patent Rules 2007, which states ‘no further fee may be paid to extend the term of the certificate unless an application for a paediatric extension is made...’, provides a mechanism with which to pay annual fees for the added two years, so long as a further six month paediatric extension is sought. However, the Court of Appeal ruled that, although, when taken literally, Rule 161(5) does not prohibit payment of further prescribed fees, the context as to what Rule 116(5) is seeking to achieve held precedence, i.e. a provision of reward for those who undertake the necessary research into paediatric indications. Thus, it was deemed “Genentech's construction would mean that an applicant for a paediatric extension was placed in a uniquely privileged position as to the payment of top-up fees as compared with other SPC applicants”.

Genentech also argued that Section 117 of the Manual of Patent Practice, concerned with the correction of errors in documents filed in connection with patents and applications, provides for a rectification of the mistakes made in the relevant SP2 form as to the length of time for which the SPC was to take effect and the corresponding fee. Despite the provision set out by Section 117, the Court of Appeal ruled payment of further annual fees remained specifically prohibited by Rule 116(5).

In response to Genentech’s further argument, the Court of Appeal ruled Genentech was not entitled to paediatric extension of six months from the date on which the SPC lapses. An extension of a shortened SPC was deemed incompatible with the EU regime, which treated the only possible extension as one which extended the maximum term of the SPC. The Court of Appeal thus refused the Appeal.

Several new drugs for the treatment of AMD have recently entered the marketplace. Novartis, who are responsible for the sale of Ranibizumab in Europe, have recently obtained EMA approval for Brolucizumab - an anti-VEGF single-chain antibody fragment. Brolucizumab, which can be administered less frequently than Ranibizumab, is expected to reach global sales of around $4.5 billion by 2026. It is expected to offer the stiffest competition to Regeneron’s AMD blockbuster - aflibercept – which first gained approval in 2011 and is expected to amass global sales of over $7 billion in 2020. Therefore future sales of ranibizumab may decline in the face of these competitor products.

Nevertheless, the Court of Appeal’s decision constitutes a huge blow for Genentech and reiterates the importance of correctly attending to payment of fees relating to patents and SPCs. As noted, ranibizumab is a highly successful drug and the loss of the full SPC term will be a significant financial loss to Genentech as it opens a door to early marketing of a ranibizumab biosimilar (if approved) in the UK.