Before entering the court, Eli Lilly and Company (Eli Lilly) should have known that it was a battle to lose. In the ten years of litigation, it gradually became aware that its rival, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (hereinafter “Hansoh Pharma”) had established strong and comprehensive patent portfolio protections for its intellectual properties. Hansoh successfully defended the accusation from Eli Lilly and demonstrated to the world its advanced process for oncology drug production. Eli Lilly failed in its effort to stop Hansoh from going global while Hansoh Pharma won the lawsuit and successfully established itself in overseas markets.
“Staying focused, dedicated and professional as a domestic forerunner of innovative drugs” is the purpose that Hansoh Pharma has always kept in mind.” Said Mr. Lyu Aifeng, Vice President of Hansoh Pharma.
In Mr. Lyu Aifeng's view, the victory is the inevitable result of Hansoh Pharma's well-developed overseas patent strategy. Lyu Aifeng told the reporter that the product that had successfully defended the accusation by foreign enterprise was gemcitabine hydrochloride (trade name: "Zefei"), an oncology drug that had won the second prize for the Advancement of Science and Technology Award in 2013. According to him, NSCLC, the indication of Zefei, has the highest incidence rate among all malignant tumor types in China. Gemcitabine hydrochloride, an effective drug for treatment of the disease, had long been under global patent monopoly. Hansoh Pharma, after many years’ efforts, finally overcame challenges including low stereoselectivity in core processes, low yield and purity of the key intermediate ribulose (4b), and difficulty in mass production of pharmaceutical grade products. In 2008, the API gained international recognition and approvals from US FDA, Japan PMDA and South Korea KFDA, the first ever in China.
After its launch, Zefei soon gained widespread praise from the society for its cheap price and better therapeutic effect. Eli Lilly, not happy with the loss of its monopoly position, filed a lawsuit against Hansoh Pharma claiming that its patent right was infringed. “The success of a product is based on R&D of innovative technologies and guaranteed by a reliable patent strategy.” Lyu Aifeng said that the well-developed patent strategy prepared Hansoh Pharma for the battle well before it began. In the face of a sudden lawsuit, Hansoh Pharma was not even a bit intimidated; instead it actively responded citing the patented production process as a defending evidence, effectively and strongly refuting the accusation from the originator drug manufacturer. The Supreme People's Court of China ruled that Hansoh Pharma did not constitute an infringement; and the three patents of Eli Lilly related to the litigation were invalidated by the Patent Reexamination Board of CNIPA. The lawsuit is a model for successful defense of alleged patent infringement by multinational pharmaceutical companies, and has been selected by the Supreme People's Court as “China top 10 cases of judicial protection of intellectual property in 2011”.
“R&D and patent protection are equally important for an intellectual property.” With its efforts in both aspects, Hansoh Pharma has successfully broken foreign monopoly and become a global knowledge leader of oncology drug. Also, with its well-developed patent strategy, it has established strong protections for its intellectual properties. In 2011, the exports of Zefei exceeded 1,000kg, accounting for 1/4 of total consumption worldwide, accumulated foreign earned income exceeding USD100 mm. Zefei had successfully established itself in the international market.
A Long Journey
"A new drug has to go through various difficulties in the long R&D process as well as patent challenges from foreign enterprises before it finally establishes itself in overseas markets." Recalling the patent litigation that Hansoh Pharma encountered, Mr. Lyu Aifeng has mixed feelings. Hansoh Pharma did not stand still in the joy of victory. Instead, in order to further explore technical advantages of the product, it has done a lot of R&D work on the basis of gemcitabine hydrochloride, and submitted 12 relevant and improvement patent applications, of which 7 have already been approved. “Comprehensive patent portfolio better protects the product and helps effectively maintain market competitiveness in the long run, allowing our product to go longer and further.” Mr. Lyu Aifeng said with pride.
Hansoh Pharma has built a domestic pharmaceutical industrial park in accordance with EU standards and introduced world-class production and testing facilities. It also has established a drug information center and an analytical test lab in New Jersey, USA. In addition, Hansoh Pharma has set up a patent affairs department as well as schemes for R&D achievements protection and for smooth communications between technicians and patent personnel. Now all API production lines of Hansoh Pharma have been officially recognized by US FDA, EU EPDM, as well as Japan and South Korea authorities, a model for Chinese pharmaceutical companies “going global”.
In 2013, Hansoh Pharma was listed as “China’s Leading Pharmaceutical Enterprise in the Internationalization of Preparation”. But Hansoh Pharma’s footsteps don't stop there. "It is our responsibility to provide patients with cheaper and better oncology drugs." Lyu Aifeng said, "We hope to break foreign monopoly through independent R&D to address the root cause of the social problem of 'expensive medical care', and transform from exporting low value-added APIs to exporting high value-added pharmaceutical products. By producing high quality locally-made medicine and promoting Hansoh brand, Hansoh tries to make its own contribution, along with other domestic pharmaceutical companies, to the transformation from 'Made in China' to 'Created in China'!”