Genentech owns an invention patent entitled “Dosages for Treatment with Anti-ErbB2 Antibodies” (Patent No. ZL 00814590.3, filed on 25 August 2000 and granted on 17 December 2008). In particular, the patent claims relate to the use of an anti-ErbB2 antibody, huMAb4D5-8, for the manufacture of a medicament for treating breast cancer in humans, and related products.
On 30 December 2011, Celltrion filed an invalidation request against the patent before the Patent Reexamination Board (PRB) on the ground that all the claims lacked novelty. The PRB, after identifying that the patent differs from the prior art only in the administration dosage and regimen, held that these differences only related to the selection of treatment protocol by the doctors, and would not necessarily relate to the medicament or formulation. Accordingly, the PRB issued a decision that all the claims of this patent were invalid for the lack of novelty.
The patentee filed a lawsuit with Beijing First Intermediate People’s Court (BFIPC) against the PRB decision, and on 19 December 2013, BFIPC issued an adjudication maintaining the invalidation decision.
The patentee then filed an appeal with Beijing Higher People’s Court (BHPC), and on 18 July 2014, BHPC issued a final adjudication and also maintained the adjudication of the first instance.
The patentee still did not agree with the final adjudication and filed a request of retrial with the Supreme People’s Court (SPC).
On 12 July 2016, the SPC issued an order refusing the patentee’s request of retrial. In the order, the SPC supported the PRB’s opinion that the administration dosage and/or administration regimen cannot distinguish the second medical use from the prior art. The order of the SPC reaffirmed the practice of the State Intellectual Property Office (SIPO) in this regard.
ISSUES AND LAW
This case is about novelty evaluation in respect of the second medical use claim (also called Swiss-type claim). The novelty requirement in article 22.2 of the Patent Law reads:
“Novelty means that the invention or utility model does not form part of the prior art, nor has any entity or individual filed before the date of filing with the Patent Office an application relating to the identical invention or utility model which is then disclosed in the patent application documents published, or the patent documents announced, after the said date of filing.”
Claim 1 of the patent is the use of anti-ErbB2 antibody for the manufacture of a medicament for treating breast cancer in humans. The only difference between claim 1 and the prior art is the administration dosage and regimen. Claim 11 of the patent is the related product comprising written instructions for administration. The difference between claim 11 and the prior art is the written instructions for administration.
During invalidation and litigation proceedings, the dispute is focused on whether the administration dosage and regimen have a restrictive effect on the second medical use claim, and thus they can make the patent distinguishable from the prior art.
DECISION AND ANALYSIS
The key point of the PRB’s decision lies in that the administration dosage and regimen only related to the selection of treatment protocol by the doctors, and would not necessarily relate to the medicament or formulation. These distinguishing technical features embodied only in the administration of medicament could not make the second medical use claim novel.
The courts of first instance and second instance upheld the PRB’s decision.
During the retrial proceedings, the SPC ruled that the second medical use claimed in the Swiss format belonged to the medicament-manufacture use claim. If the distinguishing technical features of usage, such as the object to be administered, administration mode, route, amount and interval of administration, are embodied only in the administration of medicament and have no restrictive effect on the manufacture of medicament, then the features cannot make the manufacture use claim novel.
In this patent, the administration dosage and regimen only related to the selection of treatment protocol by the doctors, and they were embodied only in the administration of medicament. In other words, such features have nothing to do with, or have no restrictive effect on, the manufacture per se. Thus, these features cannot distinguish claim 1 from the prior art. As for the product claim 11, the distinguishing technical features, i.e., the written instructions for administration, do not belong to the structural and/or compositional feature of the product, and thus, cannot make the product novel either.
Under the Chinese practice, a “Swiss-type claim” is a special type of claim that allows the applicant to seek protection for the new medical use of a known substance. The typical written form is “Use of substance X in the manufacture of a medicament for the treatment of condition Y”. Although such a claim format may make the subject matter of the second medical use patentable in China, attention should be paid to what features defined in the second medical use may contribute to the prior art.
According to the SIPO’s practice, if the contribution is only embodied in the administration of medicament and has no effect on the manufacture per se, the second medical use claim will have a risk of lacking novelty.
In this case, the SPC reaffirmed the practice of the SIPO. In evaluation of patentability of the second medical use claim, it makes clear that the use features without relation to the manufacture of medicament cannot be taken as having restrictive effect on, or contribution to, such a medical use when compared with the prior art.