Dongyangguang's first imitation patent challenge was successful, and fingolimod capsules were approved for sale in the United States
Dongyangguang's first imitation patent challenge was successful, and fingolimod capsules were approved for sale in the United States
Release time: 2022-10-12 Number of views: 2068
At the end of June 2022, the U.S. Court of Appeals for the Federal Circuit ruled that Oriental Sunshine successfully invalidated Novartis' indication patent. On October 14, 2022, the first batch of fingolimod capsules produced by Guangdong SUNSHINE LAKE PHARMA CO., LTD. Industry Co., Ltd. successfully arrived at the U.S. distributor's warehouse after a long journey. On October 18, 2022, the U.S. court officially declared that the "405 patent" was invalid, and fingolimod capsules began to go on sale. So far, Dongguan Sunshine is the first local Chinese company to challenge original drug patents in the United States and succeed.
(Figure 1: Fingolimod capsules produced by Dongguangguang)
Fingolimod is an earlier product deployed by Dongguang Sunshine and one of the earliest pharmaceutical companies in China. The project was established in July 2011 and was applied for in China, the United States and the European Union. Europe (Spain, Germany and Italy) and the United States have been approved; the Chinese registration application has been accepted in February 2020. Due to restrictions by laws and regulations, it is expected to be approved in 2025. Dongguan Sunshine submitted a first generic ANDA application to the US FDA with a PIV patent statement in September 2014, and then issued a letter of challenge to the originator Novartis, challenging the validity of two of the OB patents (US5604229 patent and US8324283 patent). Novartis used these two patents to sue Dongguan Sunshine in February 2015. Among them, the "283 preparation patent" was invalidated by other manufacturers during the litigation process. After the appeal court confirmed, the patent was ultimately invalid. The other '229 patent is a compound patent with strong stability. It went through the first instance and appeal in the district court, and finally the two parties reconciled at the end of 2017.
In December 2015, Novartis added the newly authorized US9187405 patent to the OB. At the same time, other manufacturers proposed that the IPR was invalid. In July 2018, the IPR result maintained the validity of the patent, and other companies settled and withdrew from the lawsuit. Only Dongguang Yang insisted on the trial. The first instance upheld the validity of the patent, but Dongguan was dissatisfied with the judgment and appealed to the Federal Circuit Court of Appeals; in January 2022, at the second instance, Dongguang lost the case; subsequently, Dongguan filed a request for review; on June 22, 2022, the Federal Court overturned the initial decision and ruled The '405 patent was determined to be invalid, and Novartis subsequently applied to the Federal Court for en banc review, but was rejected by the Federal Court on September 20, 2022; on October 18, 2022, a formal decision was issued that the '405 patent was invalid. So far, Dongguang Sunshine has become the only manufacturer to challenge the fingolimod patent in ANDA litigation in the United States and persist in winning the lawsuit in the end!
The successful patent challenge of fingolimod is of great significance to Dongguan.
On the one hand, fingolimod, as the world's first oral drug for the treatment of adult multiple sclerosis, has broad market prospects. The global drug market for multiple sclerosis is approximately US$23 billion. According to the GBI SOURCE global drug database, global sales of original drugs will reach US$2.79 billion in 2021. Novartis predicts that once generic drugs are launched, it may lose US$300 million in fiscal year 2022.
On the other hand, it marks that Dongguan has opened a new chapter in its internationalization journey. Dongguan Sunshine is the domestic pharmaceutical company that has challenged the most patents in the United States. It can learn from its successful experience in patent challenges and continue to develop more excellent products in the future. In the field of innovative drugs, Dongguang Solar has long been deployed in multiple fields and has a strong product pipeline in the fields of anti-infection, oncology and metabolism. Dongguang Solar has strong international research and development capabilities for U.S. first generic drugs, overseas generic drugs and improved new drugs. Through the dual engines of "innovation" and "internationalization", Dongguang Solar has become a leading domestic and internationally renowned leading pharmaceutical company.
Guangdong SUNSHINE LAKE PHARMA CO., LTD. Industry Co., Ltd. is actively promoting IPO work. The valuation of the Series A in 2021 will exceed 20 billion yuan, attracting investment from well-known institutions such as IDG Capital, Guangdong Hengjian, and Cinda Assets. The successful listing of Fingolimod in the United States will bring a large amount of cash flow to the company, bring confidence to investors, and will also put the company's asset securitization on the fast track.