HEC has successfully challenged the first generic drug patent, and Fingolimod capsules have been approved for sale in the United States
2022-10-22
After the US Court of Appeals for the Federal Circuit ruled in late June 2022 that HEC had successfully invalidated Novartis’ patent for indications, the first batch of Fingolimod capsules, manufactured by Sunshine Lake Pharma Co., Ltd. arrived at the US distributor’s warehouse after a long journey on October 14, 2022. On October 18, 2022, the US court officially declared the ’405 patent invalid, and Fingolimod capsules began to go on sale. So far, HEC is the first Chinese local enterprise to challenge the original medicine patent in the United States and succeed.
Fingolimod is one of the earlier-distributed products of HEC and one of the earlier-distributed pharmaceutical companies in China. The project was approved in July 2011 and applied in China, the United States and the European Union, among which Europe (Spain, Germany and Italy) and the United States have been approved; the application for registration in China was accepted in February 2020 and is expected to be approved in 2025 due to the restrictions of laws and regulations. In September 2014, HEC submitted the ANDA first generic drug application to the US FDA with the PIV patent declaration, and then issued a letter of challenge to the original Novartis to challenge the validity of two OB patents (US5604229 patent and US8324283 patent). Novartis sued HEC with these two patents in February 2015. Among them, the ’283 preparation patent was invalidated by IPR claims from other manufacturers in the process of litigation, and the patent was finally invalid after the confirmation of the appeal court. The other ’229 patent is a compound patent with strong stability, which has experienced the first instance and appeal of the district court, and finally reached a settlement by both parties at the end of 2017.
In December 2015, Novartis added the newly authorized US9187405 patent to OB, while other manufacturers raised IPR invalidity. In July 2018, the IPR result upheld the validity of the patent, other companies settled and withdrew from the lawsuit, only HEC insisted on the trial. The first instance upheld the validity of the patent, HEC refused to accept the judgment and appealed to the Court of Appeals for the Federal Circuit; in January 2022, HEC lost the second trial; subsequently, HEC put forward a review request; on June 22, 2022, the Federal Court reversed the initial decision and ruled that ’405 patent was invalid. Novartis subsequently applied to the Federal Court for full court review, which was rejected by the federal court on September 20, 2022; on October 18, 2022, the official decision on invalidation of ’405 patent was issued. So far, HEC has become the only manufacturer that challenges the patent of Fingolimod in the American ANDA lawsuit and insists on winning the lawsuit at the end!
The success of the Fingolimod patent challenge is of great significance to HEC.
On the one hand, as the world’s first oral drug for the treatment of adult multiple sclerosis, Fingolimod has broad market prospects, with the global drug market for multiple sclerosis of about 23 billion dollars. According to the GBI SOURCE global drug database, the global sales of the original drugs reached 2.79 billion dollars in 2021. Novartis predicts that once the generic drugs are listed, it may lose 300 million dollars in 2022.
On the other hand, it marks a new chapter in the internationalization of HEC. HEC is the domestic pharmaceutical enterprise that challenges patents most in the United States. It can learn from the successful experience of patent challenge and continue to develop more excellent products in the future. In the field of innovative drugs, HEC has a long-term layout in many fields, and has a strong product pipeline in the fields of anti-infection, tumor and metabolism; HEC has strong research and development capabilities of the first generic drugs in the United States, overseas generic drugs and improved new drugs in the world. Through the twin engines of “innovation” and “internationalization”, HEC has become a leading domestic and internationally renowned pharmaceutical enterprise.
Sunshine Lake Pharma Co., Ltd. is actively promoting the IPO work. In 2021, the valuation of round A exceeded 20 billion yuan, attracting investment IDG Capital, Guangdong Hengjian, Cinda Assets and other well-known institutions. The successful listing of Fingolimod in the United States will bring a lot of cash flow to the company and confidence to the majority of investors. At the same time, it will also make the company’s asset securitization enter a fast lane.
About HEC: HEC is a high-tech large-scale joint-stock enterprise with hopeful and focus on industry, and in the process of founding a century enterprise. After years of development, it has built three business segments covering new electronic materials, biomedicine and health care. Sunshine Lake Pharma Co., Ltd., a subsidiary of the company, was established in 2003. It is a pharmaceutical innovative R&D enterprise with innovative drug R&D, production and sales as its core business and is committed to the three fields of infection, metabolism and cancer. It is a national intellectual property rights demonstration enterprise and a provincial high-tech enterprise. In 2021, HEC has successfully merged Hong Kong listed company HEC Pharmaceutical (01558.HK) as a controlling subsidiary, and has become one of the powerful and large-scale drug research and development institutions in China. HEC is developing 50 class 1 new drugs, one of which has been approved for listing, and six of which have entered clinical phase III. HEC has 109 preparation products approved for listing in the United States and the European Union, and many products have been sold in Europe and the United States under its own brand, creating a highly mature and competitive R&D pipeline. HEC has applied for more than 2500 invention patents all over the world. It was rated as the State Key Laboratory of New Anti-Infective Drugs and the National Technology Center for Internationalization and Industrialization of Preparations. It has successively undertaken 29 national “major new drug discovery” special scientific and technological projects, and built a perfect research and development platform.
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