Top-10 Producer of Sterile Injectables
The global sterile injectable drugs market was valued at approximately US$486.6 billion in 2020 and it is expected to increase to US$929.3 billion by 2027, growing at a CAGR of 9.7%. An ‘injectable’ refers to a compound that is administered into the body of a patient using a needle and syringe, via one of several routes of administration including intramuscular, intravascular, and subcutaneous among others. One benefit of sterile injectables is their high absorption rates inside the body and quick therapeutic response.
American Regent, Inc. is a rapidly growing top-10 producer of branded and generic sterile injectables to treat humans and animals in the U.S. and Canada. American Regent is a subsidiary of the Daiichi Sankyo Group of companies and, for more than 50 years, has set high standards for responsiveness and reliability as a US-based manufacturing company. Applying their innovative thinking in response to customer needs enables American Regent to develop and deliver complex, hard-to-manufacture injectable drugs, some of which address shortages.
Joseph Wang, Assistant General Counsel at American Regent, has been with the company since 2016 and is actively involved with their patent work, and supporting R&D teams as well as the clinical, pharmacovigilance, and regulatory teams. He says, “Having access to innovation data and analytics is very important, as it helps us to understand the patent landscape”. These insights play a critical role when they are developing new products.
Preventing Duplication of Work
Prior to using PatSnap, the American Regent team relied heavily on outside counsel, and other resources. However, they needed a database to conduct their own searches where they could be confident in the data and save their work. Since bringing PatSnap on board, their team has been able to rely less on their outside counsel and bring more of their patent work in-house. With PatSnap’s Connected Innovation Intelligence solution, Wang can do a quick search and, when applicable, take a deeper dive into the prior art and conduct freedom to operate analyses. To get similar results with their previous processes, it would have taken a lot more time and effort, and there was no way to save their work for future reference.
American Regent excels at delivering difficult to manufacture drugs to market, including drugs experiencing shortages. As a result, many of their product lines are updated regularly, and they experience frequent changes in priorities. Wang says, “The ability to save our work and previous searches saves us a lot of time and effort. For various reasons, a project may go on the back burner, and we end up circling back months later – using PatSnap workspaces has saved me from having to redo a lot of my work.”
Innovation Intelligence for R&D vs. Legal Teams
When utilizing innovation intelligence, Wang describes how R&D and IP teams use this data differently. “Often R&D teams are trying to come up with new formulations or new indications – sometimes working with the clinical or medical affairs teams – and for them it is useful to look at the landscape and see where a technology may be heading.” Using PatSnap’s tool Synapse, R&D teams are provided with meaningful intelligence beyond patent data, and enables them to analyze the different delivery systems, different formulations and chemical structures, and different drug profiles as well (i.e., extended release, slow release, extra strength, etc.).
When we think of innovation intelligence for legal professionals, they would use this data differently. Wang says, “Using Workspaces, I am able to analyze competitor patents, which I can keep a database of and get alerts anytime a new patent is filed. Further, I can see the whole patent family globally, if there is litigation or legal actions, licensing etc., and this is also very useful. Additionally, being able to look at the abstract for each patent gives me a quick overview of the patent expiration, when it was published, and who the inventors are.”
Enabling legal professionals with data about competitors, legal actions, and patents all in one place allows the American Regent team to be confident when conducting freedom to operate or patentability searches, and further saves valuable time and resources.
Transforming Innovation
Since American Regent transitioned to PatSnap, they have provided professionals across the business with the tools necessary to gain a 360-degree view of the injectables landscape and industry, transforming the way they look to innovate. Some of the key features that help Wang and the team obtain this picture are:
- Email alerts: The email alerts are useful when tracking a competitor or specific patents. Wang says, “I can get updates weekly sent straight to my inbox without having to log into the platform.”
- Workspaces: Customizable workspaces have been imperative in avoiding duplication of work, as “I can go back and look at my previous searches and projects, which I would not be able to do with the free tools that are available.”
- Detailed Search: The search capabilities are great for quick analysis. “If we find a patent on PatSnap, there are different buttons we can use to search for prior art related to that patent, freedom to operate, and we can also just put in a few terms and it will come up with similar patents, and this has been very useful.”
He also enjoys that PatSnap takes feedback seriously, saying, “I can provide feedback and suggestions on features that would be helpful to me, such as organizing workspaces alphabetically. I previously was unable to do this, but I made a suggestion, eventually the product was updated, and now the tool has this capability.”
When asked, Wang says, “Overall, the tool is very impressive. Everybody can compare and contrast the different services and vendors out there, but I think PatSnap’s ease of use is what makes it stand out, and this will probably push many people to choose to go with Patsnap.”
The Need
- The ability to perform FTO analysis in house
- Save their work and previous searches
- Enable R & D Professionals with meaningful intelligence beyond patent data
