Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.
On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once every two weeks by subcutaneous injection for the treatment of rheumatoid arthritis was obvious as of June 8, 2001 (the priority date awarded by the Court to European Patent No. 1406656) and that administration of 40mg of adalimumab subcutaneously every other week for the treatment of psoriasis and psoriatic arthritis was obvious and/or anticipated as of July 18, 2003 (the priority date of the European Patent No. 1944322).
The opinion notes that “Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$ 12.5 billion.” The case was originally filed in March 2016. During the course of the litigation, AbbVie revoked (abandoned) the ’656 and ’322 patents in Europe. AbbVie also de-designated a third patent in the UK that was going to be added to the litigation, European Patent No. 2940044. AbbVie offered to sign an undertaking in which it agreed, inter alia, “not to obtain patent protection in the UK that would be infringed by certain dosage regimens.” AbbVie asserted that in view of its agreed undertakings, declaratory judgment from the Court “would serve no useful purpose.”
The Court disagreed with AbbVie, however, characterizing the language of the proposed undertakings as “complicated and very long,” and specifically pointing out that “they do not refer to anticipation or obviousness, and they do not acknowledge that the Claimants’ products were anticipated or obvious at the priority date(s).” The Court further reasoned that “threats of worldwide litigation” by AbbVie’s CEO, Mr. Richard Gonzalez, “are intended to have, and are likely to have had, a chilling effect on competition from biosimilars, including on third-party suppliers.” The Court accepted Claimant’s allegations that such threats were “likely to impede the Claimants’ ability to market successfully their products in the United Kingdom.” Therefore, the Court found that under the circumstances, the grant of declaration from the Court “would serve a useful purpose.”
Justice Carr’s opinion included additional, “[s]pecial reasons for or against the grant of the declarations,” where the Court stated that:
[O]n the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.
The Court provided its conclusions at the end a 99-page opinion in which it separately addressed the facts and evidence in support of the request for declaratory relief, the priority dates, and the merits of the technical case.
The UK Court’s ruling does not have any direct legal effect in the United States. However, there is litigation pending before Judge Robinson in the United States District Court of Delaware involving ten of AbbVie’s patents and Amgen’s proposed biosimilar adalimumab product. See AbbVie v. Amgen, Civ. No. 1:16-cv-666, (D. Del.)(SLR). Several patents related to Humira® are currently being challenged in post-grant proceedings before the PTAB. A summary of IPR proceedings on patents related to Humira® can be found in the RFEM Biologics IPR Dashboard.