16 Korean pharma win first appeal against 'Rinvoq' crystal-form patent

16 companies, including Chong Kun Dang, have successfully circumvented the patent expiring in 2036

After the expiration of the substance patent in 2032, generics can be launched early

Product photo of 'Rinvoq (upadacitinib)'

Generic companies won the first trial against the crystal-form patent for 'Rinvoq (upadacitinib),' AbbVie's oral autoimmune disease treatment.

According to the pharmaceutical industry on the 16th, the Intellectual Property Trial and Appeal Board (IPTAB) recently issued a favorable ruling in a passive scope-of-confirmation trial filed by 16 companies, including Chong Kun Dang, against AbbVie's crystal-form patent for Rinvoq (10-2753815).

Chong Kun Dang initially filed for the trial against the Rinvoq crystal-form patent in August last year. Following Chong Kun Dang, 15 other companies, including Daewoong Pharmaceutical, Alico Pharm, Genuone Sciences, Genupharma, GC Biopharma, Samjin Pharm, Sama Pharm, Kolon Pharma, Whan In Pharm, Ildong Pharmaceutical, Pharmbio Korea, LitePharmTech, Hanlim Pharm, Dong-A ST, and Huons, joined the dispute by filing identical trials.

With this ruling, the patent-challenging companies have moved a step closer to securing exclusivity for the first Rinvoq generic entrant. To qualify for the exclusivity, three conditions must be met: ▲first to file for trial ▲first to win the trial or subsequent litigation ▲first to apply for marketing authorization. Among these, the companies have now satisfied the requirements of being the first to file and winning the trial.

The patent-challenging companies plan to launch generics prematurely following the expiration of the substance patent in May 2032. Currently, two Rinvoq patents are registered: a substance patent expiring in May 2032 and a crystal-form patent expiring in October 2036. The generic companies have successfully circumvented the latter.

Rinvoq is a JAK inhibitor used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action involves inhibiting inflammatory cytokines to block inflammation, pain, and cell activation.

According to UBIST, a pharmaceutical market research firm, Rinvoq's outpatient prescription sales reached KRW 36.2 billion last year. This represents a 39% increase over the past year, up from KRW 26.1 billion in 2024. After claiming the top rank in the JAK inhibitor market in the fourth quarter of 2023, Rinvoq has steadily expanded its market share.