On February 26, 2020, the Patent Reexamination Board issued No. 42606 Invalidation Decision, declaring No. 201110327798.7 invention patent, "Antibody Purification", of which the patentee is “AbbVie Biotechnology Co.”, completely invalid. At this point, the litigation team of Lecome won the initial victory in helping to challenge the patent rights of international pharmaceutical giants and clear obstacles in the listing of domestic biosimilar drugs.

　　Humira, the King of Drugs

　　The corresponding product of the above patent is Humira, the so-called “King of drugs”. It was developed by AbbVie the US biotech giant and listed in the United States in 2003, entering the Chinese market in 2010. Humira is one of AbbVie's super-powerful products and the world's best-selling drug, which has been marketed in more than 90 countries and has been widely proven for its efficacy and safety. In the industry, Humira is widely known as the "King of Drugs". Its global sales in 2018 was $20.5 billion and expected to reach $20.97 billion in 2019, ranking the first place in the global best-selling drugs for eight consecutive years.

　　Current Situation of biosimilars in Europe and the United States

　　Humira has supported half of AbbVie's business, and AbbVie has tried to create overlapping patent portfolio barriers for Humira in various markets around the world in terms of pharmaceutical compounds, formulations, indications and preparation processes. With these patent advantages, Humira has been "on the rampage" internationally for many years, and has often been subjected to patent challenges from biosimilar drug companies, which resulted in deep involvement of all parties in patent litigations.

　　In Europe, Humira lost patent protection on October 16, 2018, and there are currently four adalimumab biosimilars available in Europe, namely, Amgevita (Amgen), Imraldi (Samsung Bioepis), Hyrimoz (Sandoz), and Hulio (Mylan/Kyowa Hakko Kirin).

　　In the US market, three adalimumab biosimilars have been approved: Amjevita (Amgen, September 2016), Cyltezo (Boehringer Ingelheim, August 2017) and Hyrimoz (Sandoz, October 2018). In the U.S., although Humira's core patent expired in 2016, AbbVie has successfully delayed the biosimilar threat until 2023 through a series of follow-on derivative patents and litigations. AbbVie has left no stone unturned in defending the US franchise of its flagship product Humira, achieving an eight-win streak. Albervi has reached agreements with Amgen, Samsung Bioepis, Mylan, Sandoz, German pharmaceutical company Fresenius Kabi, US biopharmaceutical company Momenta and US biosimilar company Coherus BioSciences. Under the terms of these agreements, adalimumab biosimilars developed by Amgen, Samsung Bioepis, Mylan, Sandoz, Freseniuscabi, Momenta and Coherus BioSciences were allowed to hit the U.S. market as early as January 31, June 30, July 31, September 30, September 30, November 20, November 20 and December 15, 2023, respectively.

　　Development of Adalimum bioidenticals in China

　　Adalimumab has low market penetration in China because high prices and fewer approved indications limit its use by a large number of patients. The drug has been on sale for nearly a decade since it was launched in the country in 2010, but in 2018 less than 5,000 Chinese patients were using it. Seeing the huge market potential, many domestic pharmaceutical companies invested heavily in research and development. As of May 2019, fifteen Chinese pharmaceutical companies have conducted clinical trials of adalimumab biosimilars in China, and four of them have completed clinical trials to start registration filings for adalimumab biosimilars.

　　Direct challenge to patent rights

　　Given the potential patent hurdles that may exist after the drug goes to market, three drug companies that are filing for listing in May 2019 decided to face potential patent risks and launch invalidation challenges to Adalimum formulation patents, two of them appointing Lecome’s litigation team as their agents.

　　Following the filing of the patent invalidation petition in June 2019, the Patent Reexamination Board set up a five-member panel as necessary for significant cases, held an oral hearing on the same day for the three invalidation petitioners' invalidation petitions against the same patent, and issued an invalidation decision in December 2019, invalidating the patent in its entirety on the basis that the disputed patent claims did not comply with Article 26 paragraph 4 of the Patent Law.

　　Domestic biosimilar drugs successfully entered the market, price of the "King of Drugs" significantly reduced, and domestic patients benefited a great deal

　　In November 2019, the first domestic adalimumab biosimilar drug obtained approval for the market, and several other drug companies’ biosimilar drugs are also on the way to the market. In order to fight for market share, the "king of drugs" also lowered its head. On November 28, 2019, results of the "2019 national health insurance negotiations" were announced. Humira entered the health insurance coverage at 1290 yuan per dosage, the price being 83% lower than before (7600 yuan per dosage). One subcutaneous injection every two weeks, the monthly cost is 2580 yuan, which is already below the price level of similar products.

　　The patent attorney for the patent invalidation claim was Huang Renmin, and the assistant attorney was Wei Zi.