Legal disputes between PMG Pharm Korea and generics companies including Mother’s Pharm have intensified over Layla, medication for osteoarthritis originally developed by PMG Pharm한국PMG제약 that sells 20 billion won a year in Korea.
Following the July decision of the patent court that nullified the Layla’s usage patent, a Seoul court recently dismissed PMG Pharm’s petition for an injection against generics firms over the composite patent. This allowed generic firms to launch their generics products in the near future.
Ten generics makers including Mother’s Pharm have already received medical coverage and plan to release copies of Layla in September.
However, PMG Pharm immediately appealed to the supreme court about the patent court’s dismissal over the usage patent. The company said it will also appeal the latest decision by the Seoul court over the dismissal of the injunction. Accordingly, legal disputes between PMG Pharm Korea and generic companies are expected to continue.
The Seoul Central District Court on Friday dismissed the PMG Pharm’s petition for a preliminary injunction against 10 drugmakers including Mother’s Pharm. Nine others are Kukje Pharma국제약품(Ostera), Daewon Pharm대원제약(Onenella), Mother’s pharmaceutical마더스제약(Laybone), Binex바이넥스(Skella), Aju Pharm아주약품(Osfen), Arlico Pharm알리코제약(Laystar), Inist Corp.이니스트바이오제약(Raynt), Kora Global Pharm한국글로벌제약(Guardbone), Hutecs Korea Pharmaceutical한국휴텍스제약(Nailloc), Hanlim Pharmaceutical한림제약(Leas).
PMG Pharm filed for the petition the injunction over the composite patent that expires on June 24, 2029. To defense against generics firms, PMG Pharm the registered additional patents in October last year over the restoration of cartilage, pain control and swelling control. Even when the usage patent expires, generics firms have to delay the release of their copy products if they fail to avoid the composite patent.
But the court dismissed the petition, saying “the progression of the patent is denied.” Generics companies including Mother’s Pharm have registered their copy products to the insurance coverage and are in preparation to release their copies in September.
With the imminent release of the generics, PMG Pharm said it would appeal immediately.
Mother’s Pharm is currently appealing to the court about the invalidity of the court’s decision over the Layla’s composite patent. Mother’s Pharm predicts the latest dismissal of the composite patent will affect the appeal.
PMG Pharm’s usage patent of Layla expires on Dec. 20, 2022 and the composite patent on June 24, 2029. Generics firms obtained preferential rights to sell the first generic of Layla on July 19.
“I think there was an error in the court’s interpretation on the composite patent of Layla. There was misunderstanding about standards of acanthoside D content. I think it is right to cancel the dismissal,” said an official at PMG Pharm Korea.
As the Intellectual Property Trial and Appeal Board(IPTAB) will rule on the Layla patent and the trial on the merits of a case is underway, the official expected the court would make a right judgment,
The official also expected that the supreme court would cancel the lower court’s decision that called the usage patent of Layla invalid.
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