Genentech owns an invention patent entitled "Dosages for Treatment with Anti-ErbB2 Antibodies".(1) The patent claims predominantly 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 December 30 2011 Celltrion filed an invalidation request against the patent before the Patent Re-examination Board on the ground that all of the patent's claims lacked novelty. After identifying that the patent differed from the prior art only with regard to the administration dosage and regimen, the board held that these differences concerned only the selection of treatment protocol by doctors and did not necessarily concern the medicament or formulation. As such, the Patent Re-examination Board issued a decision that all of the claims were invalid due to lack of novelty.
The patentee filed a lawsuit against the board's decision with the Beijing First Intermediate People's Court. On December 19 2013 the court issued an adjudication maintaining the invalidation decision.
The patentee subsequently filed an appeal with Beijing Higher People's Court. On July 18 2014 the court issued a final adjudication, which maintained the first-instance decision.
The patentee disagreed with the final adjudication and filed a request for a retrial with the Supreme People's Court. On July 12 2016 the Supreme People's Court refused the patentee's request for a retrial. In its order, the court upheld the Patent Re-examination Board's opinion that the administration dosage and administration regimen could not distinguish the second medical use claim from the prior art. In this regard, the Supreme People's Court's order reaffirmed the practice of the State Intellectual Property Office (SIPO).
This case concerned the evaluation of novelty in respect of a second medical use claim (also referred to as a 'Swiss-type' claim). In this regard, the novelty requirement in Article 22.2 of the Patent Law reads as follows:
"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 Genentech's patent concerned the use of the 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 was the administration dosage and regimen. Claim 11 of the patent concerned related products, comprising written instructions for administration. The difference between Claim 11 and the prior art was the written instructions for administration.
The dispute at issue in the invalidation proceedings and subsequent litigation focused on whether the administration dosage and regimen had a restrictive effect on the second medical use claim and could thus distinguish the patent from the prior art.
The key point of the Patent Re-examination Board's decision was that the administration dosage and regimen related only to the selection of treatment protocol by doctors and did not necessarily relate to the medicament or formulation. These distinguishing technical features embodied only in the administration of the medicament did not make the second medical use claim novel.
The first and second-instance courts upheld the Patent Re-examination Board's decision.
During the retrial, the Supreme People's Court 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; the administration mode, route and amount; and the interval of administration – are embodied only in the administration of a medicament and have no restrictive effect on the manufacture of the medicament, the features cannot make a manufacture-use claim novel. As regards Genentech's patent, the administration dosage and regimen concerned only the selection of treatment protocol by doctors and were embodied only in the administration of the medicament. In other words, such features were unrelated to and would have no restrictive effect on the medicament's manufacture per se. Thus, these features could not distinguish Claim 1 from the prior art. As for Claim 11, the distinguishing technical features (ie, the written instructions for administration) were not part of the product's structural and compositional features and thus could not make the product novel.
In Chinese practice, a 'Swiss-type' claim allows patent applicants to seek protection for a 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 which features defined in the second medical use may contribute to the prior art. According to the SIPO's practice, if the contribution is embodied only in the administration of the medicament and has no effect on its manufacture per se, the second medical use claim will risk lacking novelty. In the case at hand, the Supreme People's Court reaffirmed the SIPO's practice. In its evaluation of the patentability of the second medical use claim, the court clarified that use features which do not relate to the manufacture of a medicament cannot be considered to have a restrictive effect on or make a contribution to such a medical use when compared with the prior art.
