What are the headline differences in patent term restoration systems across the main IP jurisdictions?
In the US, a patent can only be extended one time for development and regulatory review delays, regardless of whether the patent covers more than one product. Furthermore, only one patent can be extended for the same regulatory review period of a product, and the combined remaining patent term plus extended term cannot exceed 14 years. A patent claiming a combination product may be entitled to patent term extension (PTE) as long as one of the active ingredients in the combination has not previously been commercially marketed. And new salts or esters of a previously-approved product may also be eligible for PTE.
In the EU, that cap on the remaining patent term plus an extended term – via a supplementary protection certificate (SPC) – is a maximum of 15 years. The SPC Regulation has been interpreted to allow grant of an SPC even if the specific compound is not expressly named or mentioned in the patent as long as the active ingredient in question can be “specifically identifiable in light of the information in the patent”.
There is no corresponding cap to the combined patent-plus-extended term in Japan – up to five years can be added to the patent term. Furthermore, multiple patents can be granted extensions for the same approved product and, in fact, the same patent can be extended more than one time for new indications. Any new marketing authorisation (MA) may entitle a patent to a new extension as long as it differs from the previously approved product on the basis of ingredient, quantity, dosage form, or efficacy. However, it remains to be seen whether the grant of new PTEs for distinct aspects of a product will limit their value.
What are the pros and cons of allowing an SPC to a patent holder who is not the marketing authorisation holder?
As in-house counsel for a company that is most interested in protecting its own investment into clinical trials and efforts to develop new medicines, I find it hard to justify allowing a patent holder who is not the MA holder to obtain an SPC. However, there is a pending referral to the Court of Justice of the EU on the subject of third party SPCs, and I hope we will receive some clarifying guidance from that decision.
What are your views on the SPC manufacturing waiver?
The waiver, including the ability to stockpile medicines for up to six months, is a rather surprising development, particularly given the fact that the EU itself brought a WTO dispute against Canada for allowing manufacturing and stockpiling, albeit during the patent term. It is difficult to reconcile the manufacturing waiver with the original basis for creation of SPCs.
What will be the biggest challenge when it comes to managing the provisions of the SPC waiver?
There are a few: (1) there are some ambiguities in the new amended regulation, for which we will probably only get clarity after litigation and subsequent court interpretation; (2) the staggered entry into force of the new waiver provisions means some innovator companies are going to be affected first (and will have the attendant uncertainty that comes with seeking clarity via litigation); and (3) the requirement for innovator companies to monitor and ensure the waiver is appropriately used by generics manufacturers is an extra burden to innovator companies, which is not in anyone’s interest (and indeed, is antithetical to the reasons for which SPCs were developed in the first place).
Is the SPC regulation fit for purpose for new or upcoming therapeutic treatments such as (but not limited to) CRISPR-Cas9, CAR-T or other forms of personalised medicine?
The basis for SPCs is perhaps stronger for new therapeutic treatments; therefore, yes, the original SPC regulation is ‘fit for purpose.’ New therapeutics are more likely to undergo longer periods of regulatory review, and the longer term protection provided by SPCs was exactly the appropriate incentive for innovators to undertake the additional time and financial resources required for the development of such therapeutics. Of course, it would be impossible to create any legislation that could foresee every new technological advance; therefore, such advances will need to be addressed as they have been previously – that is, by interpretation of the SPC regulation by the courts.
Are unitary SPCs desirable? If so, which organisation should examine them?
Yes, industry continues to support the notion of a unitary SPC. Industry has previously taken the position that a unitary SPC should be examined by a new body, which could be composed of SPC experts from national patent offices.
What does the future hold for patent term extensions outside the EU?
China has recently introduced a bill that includes patent term extension (PTE) to allow the patent holder to recoup time lost in regulatory review. The proposed term is five years, with a 14-year cap. However, there are some ambiguities in the draft amendment that need to be further clarified. For example, the draft provision appears to include a requirement that the request for MA be submitted simultaneously in China and other countries, which is not practical and would undermine the value of the new provision. As with other provisions of Chinese patent law, the value of a new PTE provision will come down to how it is interpreted and applied in practice.
In Israel, a recent court decision clarified that PTE is available for an antibody product that targets the same antigen as a previously-approved antibody. The Israeli PTO noted that eligibility for PTEs should depend on structural differences between the antibodies (not the antigen to which they bind). Even if such structural differences are insignificant, a patent for a second antibody product may still be eligible for PTE if there are substantial differences in activity.
