April, 2016｜News Letter

To What Extent Can Disclosures on Disease be Considered in Examining Inventive Step of Claimed Invention Relating to Another Disease when Pathogenesis Thereof are in Common with Each Other?

Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals and Teva Pharmaceutical Industries Ltd., Case No. 2015 (Gyo-Ke) 10033 (Decision rendered on April 20, 2016)

The Patentee, Merck Sharp & Dohme (MSD), obtained a patent relating to a pharmaceutical composition for treating androgenic alopecia in 2000. Against the MSD's patent, Mylan filed an invalidation trial with the JPO in 2013, and Teva intervened in the trial. During the trial proceedings, MSD demanded a correction of claims, and the JPO admitted the correction, but rendered a decision of invalidation in 2014 on the grounds of lacking inventive step over prior art reference (p.a.r.) 1 in view of p.a.r.s 2 to 5, followed by MSD's appeal against the JPO's decision to the IPHC in 2015.

The corrected Claim 1 of the MSD's patent at issue claims as follows:
An oral form pharmaceutical composition for treating androgenic alopecia in human comprising 0.05 to 1 mg of 5-reductase 2 inhibitor as An oral form pharmaceutical composition for treating androgenic alopecia in human comprising 0.05 to 1 mg of 5α-reductase 2 inhibitor as a unit dose and a pharmaceutically acceptable carrier.

One of the main issues in this case lied in to what extent disclosures on a disease could be considered in examining inventive step of a claimed invention relating to another disease when the pathogenesis thereof were in common with each other. The IPHC answered to the issue as follows:

First, having reviewed Claim 1 of the patent at issue and p.a.r. 1 in detail, the IPHC found (i) that there were three differences between them, and the third one was that the former specified a dosage as “0.05 to 1 mg … as a unit dose”, while the latter demonstrated “0.5 mg/day” in working examples, and (ii) that p.a.r. 1 suggested that there could be any correlation between the decrease of dihydrotestosterone (DHT) concentration in blood serum and the increase of weight of hair of scalp.  Further, regarding the dosage, the IPHC carefully considered p.a.r.s 2 to 5 and found that p.a.r. 2 demonstrated that all administrations of doses of 0.04 mg/day, 0.12 mg/day, 0.2 mg/day and 1.0 mg/day for 14 days showed remarkable suppression of DHT concentration in blood serum; p.a.r. 3 demonstrated that all administrations of doses of 1 mg/day, 5 mg/day, 10 mg/day, 50 mg/day and 100 mg/day for 7 days showed decrease of DHT concentration in blood plasma and in prostate gland; p.a.r. 4 demonstrated that the single administration of dose of 0.5 mg/day or 1.5 mg/day decreased DHT concentration in blood plasma by 50% after 24 hours; and p.a.r. 5 demonstrated that the administration of dose of 1 mg/day or 10 mg/day for 7 days decreased DHT concentration in blood serum.
On the basis of the above findings, the IPHC decided that those skilled in the art could have easily conceived the third difference as the dosage which could decrease DHT concentration in blood serum in view of p.a.r.s 2 to 5.

In this connection, during the court proceedings, MSD asserted that all of p.a.r.s 2 to 5 were literatures relating to the treatment of benign prostate hypertrophy and they had no disclosures relating to the treatment of androgenic alopecia, thus they had no disclosure or suggestion which could be associated with the treatment of androgenic alopecia.  However, the IPHC rejected the MSD's assertion by pointing out that prostate hypertrophy occurred with excess accumulation of androgen as is the case with androgenic alopecia, thus that those skilled in the art obviously referred to p.a.r.s 2 to 5 when they tried to determine the dosage in an effort to decrease DHT concentration in blood serum which could have some correlation with the increase of weight of hair of scalp for the treatment of androgenic alopecia, and therefore that the above fact asserted by MSD constituted no disincentive factor against considering p.a.r.s 2 to 5.

Conclusively, the IPHC dismissed the MSD's appeal and maintained the JPO's decision.

An appeal to the Supreme Court was filed against this decision, and thus the decision is NOT final and binding.

K&P’s CommentsThe above IPHC's decision found that disclosures on doses for a disease could be considered in examining inventive step of a claimed invention relating to another disease when the pathogenesis of them were in common with each other. Accordingly, when inventive step of a claimed invention relating to a disease is considered, attention should be paid not only to disclosures on the same disease but also to disclosures on different diseases having a common pathogenesis in various aspects.

In April 2016, the IPHC handed down 11 decisions including the above case on patent, and maintained all of the previous decisions.

In April 2016, the IPHC handed down 6 decisions on trademark, and overturned the previous decisions in 1 case.