Prepare a forum for the exchange of views on patents, the core of the pharmaceutical industry, including strategies to protect the patent rights of ‘Humira’ and ‘Keytruda’, which compete for the main global pharmaceutical sales, and prepare a patent system for development drugs with digital and artificial intelligence (AI) technology in the future is done.
In the 3rd day conference of Bio Korea 2023 (BIO KOREA 2023), ‘Evergreen’, strategy for patent term extension and patent expansion, and preparations for the patent protection system for drugs developed in virtual space (in in silico) rather than in vitro, etc. this was presented
Humira expands 79 patents to 746… 42 years ‘unique position’
Humira (ingredient: adalimumab) is the first fully human monoclonal antibody treatment developed and currently owned by AbbVie. Kim Tae-kwon, head of the Korea Patent Technology Promotion Institute, announced that Humira had expanded the original application patents from 79 at the time of release to 746 through substances, medicinal uses, formulations, compositions, and manufacturing methods, and as a result, ensured monopoly position for 42 years.
“Even if the patent on Humira were to expire, it would maintain its monopoly position by holding patents on medicinal uses and manufacturing methods,” said Kim Tae-kwon, a senior manager. We implemented a strategy to block the entry of Miller (a bioreplicable drug),” he explained.
According to him, starting with the substance patent ‘US6090382A’ in 1996, Humira will expand its medicinal use patents from rheumatoid arthritis to psoriatic arthritis and ankylosing spondylitis in 2001, and from moderate to severe chronic plaque psoriasis in 2014.
After that, a family group was formed with patents related to manufacturing methods, and expanded to include △ a method for producing fed-batch culture △ a method for increasing the galactosylation level of antibodies △ a method for purifying antibodies and removing acidic species. Since then, between 2002 and 2038, when antibody drug conjugates (ADCs) were first approved by the US Food and Drug Administration (FDA), protection rights were secured for 35 years (42 years after substance patents).
Keytruda secures a ‘unique position’ by 2040
Keytruda (ingredient: pembrolizumab) is an immune checkpoint inhibitor that acts on PD1. A patent was registered in 2013, and FDA approved in 2014 as a melanoma treatment. Since then, the indications have been expanded to include non-small cell lung cancer and triple-negative breast cancer.
In the case of Keytruda, starting with 67 original patents, it has secured 345 patents to date. In particular, Keytruda has a total of 17 indications, two of which are so-called disease-free indications. Director Kim Tae-kwon explained that this is possible because the ingenuity of the treatment mechanism is different from that of chemical anticancer drugs and targeted anticancer drugs as anticancer drugs.
Chief Kim Tae-kwon explained, “In the case of Keytruda, we are using an ‘evergreen’ strategy in the form of a higher patent barrier for medicinal use, and the patent protection period has been secured until at least 2040.”
He said that the biggest difference between a biopharmaceutical patent protection strategy and a chemical medicine strategy lies in the manufacturing method patent, and that this should be reflected in the patent strategy for targeting the global market in the future. Responsibility Kim said, “Synthetic drugs have many improvement patents such as crystalline, polymorph, and intermediate patents, but biopharmaceuticals have antibody or protein improvement patents, but the number is small and the distribution of manufacturing process patents is large.” In order to move forward, we need to address patents related to formulations, formulations, and therapies as well as the end of substance patents.
Drugs to be developed in virtual space… The in silico strategy should come out
As the purpose of patents is to guarantee exclusive rights by recognizing contributions to industrial development through technology development, this should be reflected if the method of technology development changes. Cho Kyung-joo, head of the biopharmaceutical patent team at the Korean Intellectual Property Office, said bio-field inventions are grafted on information technology (IT) and artificial intelligence (AI) technologies.
Team leader Cho Kyung-ju said, “Current medical practices (treatment, diagnostic surgery) were not recognized as patents, but software (SW) or AI, which is not a medical person, has been patented, and inventions for medical use related to personalized medicine are also recognized as new medical uses. Following the enhancement of the audit criteria in 2019, we are currently considering a new audit approach for devices that use computers.”
According to him, inventions made by conventional methods, such as inventions using existing computers, were excluded from the subject of patents, but recently, digital manipulation devices and technologies using computers such as protein tertiary structure prediction are developing, and recently, the use of digital drugs and AI alone have been developed There is a growing awareness that the form of a patent application, such as this design, should also be tailored to this.
He said, “As digital is being applied to general biopharmaceutical devices as well as new digital devices, the market is growing, so we want to create specific standards.” We anticipate the device description requirements using
