HONG KONG – In a final ruling, the U.K.'s High Court of Justice ruled in favor of Tokyo-based Fujifilm Kyowa Kirin Biologics Co. Ltd. in a patent revocation proceeding against Abbvie Inc., which has been fighting to protect its blockbuster Humira (adalimumab).
"Fujifilm Kyowa Kirin Biologics commenced patent revocation proceedings against Abbvie for about one and half years," Hiroki Nakamura, a senior manager at Kyowa Hakko Kirin's corporate communication department, told BioWorld Asia. "The results of the U.K. high court [were] favorable for Fujifilm Kyowa Kirin Biologics, however we cannot comment on the impact of the result including forecasts of our biologics business."
Following the March 3 decision, shares in Kyowa Kirin Biologic's parent company Kyowa Hakko Kirin Co Ltd. jumped to ¥1,750 (US$15.40), its highest price in the past three months.
The patent revocation proceedings started on Oct. 29, 2015, and focused on the validity of certain adalimumab dosing regiments.
The action was brought in relation to FKB327, an adalimumab biosimilar candidate, a fully human anti-TNF-a monoclonal antibody referencing Humira that Fujifilm Kyowa Kirin Biologics is developing.
Adalimumab is sold under the trade name Humira, among others and it is used to treat rheumatoid arthritis, psoriasis and psoriatic arthritis. The drug is one of the highest-selling prescription drugs in the world, with net sales in 2014 in excess of $12.5 billion.
The drug's patent expired in the U.S. in December 2016, while in the European markets it will expire in October 2018.
In the U.K., Abbvie U.K., a company incorporated in England, markets Humira. The company hit turnover of £438.6 million (US$538 million) on Humira in 2014, approximately £1.2 million a day.
With these numbers in mind, it is not surprising that Abbvie would fight to protect its patent. The company has, in the past, issued strongly worded statements to its competitors.
"Any company seeking to market a biosimilar version of Humira will have to contend with this extensive patent estate which Abbvie intends to enforce vigorously. . . . In the event a biosimilar attempts to launch at-risk, Abbvie will seek injunctive relief," said Rick Gonzalez, Abbvie Inc.'s chairman and CEO in relation to its U.S. patent portfolio, during the company's third quarter earnings report on Oct. 30, 2015.
Under the development code FKB238, Fujifilm has been developing a biosimilar candidate of the anti-VEGF humanized monoclonal antibody Bevacizumab, a drug used to treat a range of cancers including colorectal and non-small-cell lung cancer.
A phase III global study of FKB238 is being conducted by Centus Biotherapeutics Ltd., a joint venture established by Fujifilm Kyowa Kirin Biologics and Astrazeneca plc.
So far, the company said it has achieved major objectives in the trial and is preparing to file its application for marketing authorization of its biosimilar, but patent litigations create a regulatory hurdle for Fujifilm Kyowa Kirin Biologics.
The company said its biosimilar and Humira performed equivalently in a trial at improving the disease activity of rheumatoid arthritis after 24 weeks of treatment, as measured by ACR20 response, and no major difference was observed in adverse events.
The parent company, Kyowa Hakko Kirin, has been aggressively expanding its bio-arms. It set up a new biosimilar subsidiary, Kyowa Kirin Frontier Co. Ltd. on Feb. 8.
Kyowa Hakko Kirin said the new subsidiary was its response to "changes in the social environment surrounding health care in Japan and the diversification of the needs thereof, and to meet social demands for medical cost containment."
The company will be selling a version of Aranesp (darbepoetin alfa) it is developing with Amgen, which has been filed for review in several countries according to an R&D pipeline update included in Kyowa Hakko Kirin's 2016 report.