Knowing when to file patents and devising a corresponding strategy are essential when entering the US market, according to speakers at the 4th China Pharma IP Summit in Shanghai.
“The advantage with delaying filing until a drug is close to the investigational new drug stage is that you can get rid of any freedom-to-operate (FTO) issues,” said Andy Zhang, senior corporate counsel at Sunovion Pharmaceutical. By this stage, it’s possible to draft claims with strong validity, he said. Additionally, the project team can generate data to support the invention and there is a more effective patent term for the drug, Zhang added, but he pointed out that the drug may miss out on patent term extension.
On the other hand, it might be advantageous to build in a developed drug candidate and file early to avoid being stopped by any competitors, Zhang said. For secondary filings, he added, it is still best to file earlier because generics will be watching the pipeline more closely and there might be FTO issues.
Focusing on startups, Teresa Lavoie, principal at Fish & Richardson, said that it is best to delay filing as much as possible. “Startups want to have a longer term because they need to have a portfolio to build interest with key opinion leaders and investors. It’s important to establish yourself in the target space to attract big pharma.”
Caihui Li, senior IP director at 3SBio Group, shared from her experience that it is best to file as soon as possible, both in China and the US, on the premise that the drug data is sufficient.
An important point to remember for generics going into the US is the on-sale bar provision, which specifies that a drug can’t be patented if it has been on sale for over a year before the filing. “This is something to keep in mind for companies that are outsourcing production or have contract manufacturing because it could affect patentability,” said Lavoie.
One question to ask is where to file when there are multiple inventors, for instance if a drug was developed by both Chinese and US inventors. Lavoie suggested that in this situation, it would be best to do a PCT filing in China as such filings are in English, meaning there is no burden of translation, and then ask for an expedited review in the US. Zhang added that sometimes senior executives may be nominated as inventors, which could make a patent unenforceable, so having accuracy on who the inventor is key.
Having a good analysis of a country’s industry landscape is key. “It’s important to have a deep understanding of where the product will be made and sold, prospective partners, and how easy it is to get protection in the country,” said Zhang. Other issues to keep in mind are the patentability of the drug in the country, the difficulty of prosecution and whether enforcement is a problem. It’s about balancing and adjusting based on the business’s interests, he said.
“Each company should have a filing list and adjust according to the geographical area,” said Zhang. “For instance, for some drugs targeting infectious disease, it might be better to file in Southeast Asian and African countries because of the commercial opportunities.”
