The unusual circumstances of Fujifilm and AbbVie’s Humira patent case and its potential impacts on the market

When every day of patent protection can mean millions of pounds of revenue, it is hardly surprising that patentees pull out all the stops to build and protect their patent portfolios.

It is now commonplace to file secondary patents to extend patent protection beyond the expiry of the original patent for a drug, protecting developments such as improved methods of manufacture, formulations and dosing regimens. AbbVie’s filing of secondary patents to protect its blockbuster drug Humira formed the basis of its hard-fought battle with Fujifilm.

Humira is a monoclonal antibody drug which inhibits cell signalling protein TNF alpha in inflammatory autoimmune diseases including rheumatoid arthritis, psoriasis and Crohn’s disease. Humira is a blockbuster in the truest sense. In 2016, its global turnover exceeded $16 billion, with daily UK sales of around £1.2 million, making it the highest-selling drug in the world.

Facing the expiry of the Humira antibody patent in October 2018, AbbVie filed a series of applications for secondary patents, including for Humira dosing regimens.

Several companies have now developed their own monoclonal antibodies biosimilar to Humira, in preparation for launch when the original Humira antibody patent expires in October 2018. To proceed to launch, those companies faced having to challenge, and clear the way of, AbbVie’s secondary patents.

Unusual circumstances

Fujifilm Kyowa Kirin Biologics was the first biosimilar developer to seek to revoke the Humira secondary patents in the UK courts. However, shortly after Fujifilm commenced proceedings, AbbVie abandoned one of its granted patents and three patent applications, while continuing to pursue applications for further patents claiming essentially the same subject matter (but those applications would not be granted for some time).

A few months before the trial of the case, AbbVie abandoned further patents which, by then, had been granted. Again, AbbVie retained patent applications which it could pursue, but which would not be granted for some time.

When a patent is an ungranted application, there is no mechanism in the Patents Act for a party to try to revoke it; that party must instead wait until the patent has been granted. This creates a significant risk for companies seeking to launch biosimilar or generic drugs where there are ungranted patent applications – if the drug is launched, it may later have to be withdrawn from the market if the patent owner commences infringement proceedings, or if the company fails to revoke the granted patent.

Fujifilm’s last resort

Facing AbbVie’s portfolio of ungranted patent applications, Fujifilm applied to the court for a new type of legal remedy – a declaration that using its own biosimilar in the relevant dosing regimen would have been obvious at the date of the patent. If it succeeded, Fujifilm would then be safe in the knowledge that if using its own biosimilar in a dosing regimen was obvious, AbbVie would be unable to obtain a valid patent for that dosing regimen (if the dosing regimen was obvious, the patent would be invalid).

In effect, this would give Fujifilm protection against infringement actions should any patents concerning that dosing regimen be granted.

While it is well-established that the UK court has discretion to grant declaratory relief, there was much debate over whether the court could award the type of declaration Fujifilm sought. AbbVie argued the court was not permitted to do so because, effectively, the declaration would challenge the validity of a patent, the Patents Act specifies the circumstances in which validity can be challenged, and this was not such a situation. Fujifilm argued that the Patents Act should not be read so restrictively, and the court had a wide discretion to grant declaratory relief.

This question was appealed to the Court of Appeal in an interim application, before the trial of the case.

The Court of Appeal confirmed that the UK courts did have jurisdiction to grant declaratory relief, at their discretion, but declarations of this nature would only be available in unusual circumstances, for instance when the normal statutory route to clear the way (such as seeking revocation of a granted patent) were not available.

In the High Court’s judgment of 3 March 2017, the judge then considered the factors relevant to deciding whether to exercise its discretion to grant the declaration: whether the declaration would serve a useful purpose; whether there are special reasons why the court should grant the declaration, justice to the claimant; and justice to the defendant. The judge focused on whether the declaration would serve a ‘useful purpose’, and the other factors were considered only briefly as most of the points overlapped.

‘Useful purpose’

At the time of its second abandonment of patents, a few months before the trial, AbbVie offered the court undertakings that it would not obtain any patent protection for the dosing regimens in the UK. AbbVie argued that, in light of these undertakings and its abandonment of the patents, Fujifilm had succeeded in clearing the way and there remained no ‘useful purpose’ for the declaration.

The judge, Henry Carr J, accepted Fujifilm’s argument that there must remain a useful purpose as AbbVie refused to submit to judgment. He found that there remained commercial uncertainty as a result of AbbVie’s practices of abandoning its granted patents and filing new applications, finding that “… AbbVie has made every effort to shield the claims of its patents from scrutiny in the EPO and in the UK Court”, and the declarations would resolve that uncertainty. The judge also recognised that the declaration would have valuable “spin-off” value, being a judgment which is persuasive in other jurisdictions. However, he cautioned that “it is important not to extend this principle too far” and “a declaration which is sought solely for the benefit of foreign courts will rarely be justified”.

‘Special reasons’

The special reasons supporting the grant of the declaration included that AbbVie had threatened infringement proceedings at the same time as abandoning its patents, there was a need for commercial certainty, and given the amount of money at stake for Fujifilm (its investment and potential damages if it was forced to launch without clearing the way). The court then granted the declaration that Fujifilm sought.

A new mechanism to clear the way

While the Fujifilm case marks the creation of a mechanism for clearing the way of ungranted patent applications, the Court of Appeal made clear that such remedies will not be available in every case. Where a company faces an ungranted application the course envisaged by the statute is that he should wait and see what, if any, patent is granted”. The patent can then be challenged once it has been granted.

The range of factual circumstances required to justify the grant of a declaration remains to be seen. The circumstances in the Fujifilm case were very complex and quite unusual, and caused considerable uncertainty in an exceptionally high-value market.

This new remedy may be useful to any companies facing ungranted patent applications, from biosimilar/generic manufacturers, to licensees and companies fending off patent trolls (provided ‘unusual circumstances’, ‘special reasons’ and ‘justice to the parties’ can be demonstrated). Patent proprietors should be mindful of patent filing strategies and public statements that may create commercial uncertainty.

The potential disadvantage of Fujifilm declarations is that they are personal to the party seeking the declaration. If one company obtains a Fujifilm declaration and another company wished to launch products of its own, the second company would either have to launch at risk in the hope that the patentee would no longer assert its patent (given that the subject matter of the patent had been shown to be obvious), or commence a case of its own, seeking its own declaration. The extent to which these secondary declaration cases may be streamlined by the courts remains to be seen.

Jenny Davies is a principal associate at Gowling WLG