Dr. Janet (Jian) Xiao, co-chair of the global Life Sciences Group, was quoted in MedCityNews article “Drug patents expiring in 2017? It’s all smoke and mirrors” regarding drug patent expirations complexity.
“I see a lot of articles talking about, ‘this patent for this biologic expires in 2020,’ said Janet Xiao, ‘That may not be the complete story.’ There are many ways to achieve a longer patent life, said Xiao in a phone interview, including through the use of second generation patents. These are filed later and last longer. The new IP could cover anything from manufacturing processes to a new drug formulation.”
“For biologics, it’s even more complex,” Xiao said. “By nature, they are very complex large molecules, so there are a lot of strategies that you can try to get patent protection.”
Xiao gave the example of an antibody drug. The inventor would have patented the original antibody very early on. But as the company advances the molecule, it may see an opportunity to patent a particular antibody sequence. Later on, the scientists could claim a small but meaningful therapeutic modification. They could file to protect the manufacturing process or claim rights to a second disease application.
If all of these patents are filed strategically, over time, the drug won’t lose exclusivity when the original formulation becomes a free-for-all.
“Savvy drug developers keep the patent filing strategy in mind as the research and development progress,” Xiao said. “They don’t just freeze at the time when the antibody was discovered, they constantly communicate with the research team and see what’s new, what’s the lead candidate, are there any patents that we can file on that? So it’s a dynamic process.”