Inventors are facing new legal challenges that can continue well after the grant of provisional or non-provisional patents. Invalidation of patent claims has become a familiar tool used by companies that are vying for market position. By leveraging administrative challenges, companies can invalidate existing intellectual property (IP) claims and clear legal paths to produce new IP for themselves.
Now, inventors are applying freedom-to-operate large language models to prior art research as a bulwark against future novelty issues.
The Rise of Patent Claims Invalidation
Many believe that the long and frustrating process of protecting their invention ends once the patent office grants a patent. They are confident that after waiting an average of three years from filing) and paying hefty fees (mostly to lawyers), their ordeal is finally over. They can continue doing business, believing they are protected from imitation or competition.
Unfortunately, these inventors don’t realize how wrong they are.
On September 16, 2011, the Leahy-Smith America Invents Act (AIA) was signed into law by President Barack Obama. The main purpose of the AIA was to improve patent quality, simplify the patent process, and harmonize the U.S. patent system with other countries.
One key aspect of the act changed the U.S. patent system from "first to invent" to "first to file" (see also the importance of provisional patents). Another key change was the introduction of the Patent Trial and Appeal Board (PTAB).
PTAB is a panel within the U.S. Patent and Trademark Office (USPTO) that focuses on hearing administrative challenges to the validities of patent claims. Through the AIA, Congress amended the ex parte and inter partes reexamination proceedings and added post-grant review (PGR). Each of these court functions are types of post-grant proceedings facilitated by the USPTO.
The PTAB and the amended post-grant proceedings have had a consequential effect on patent defense and protection. But what most people didn’t expect when the AIA was passed is that the PTAB would end up invalidating patent claims in more than 60% of the cases.
Merck v. Halozyme
As the PTAB becomes a more prominent source of patent disputes (96% IPRs, 4% PGR), we see more and more companies leveraging PTAB proceedings across multiple verticals. A recent example comes from the Bio/Pharma world in the case of Merck v. Halozyme.
Halozyme Therapeutics is a company that researches and develops drug delivery technologies, including enzymes for drug injections. Their technology is protected by U.S. patents. Utilizing hyaluronidase enzymes to develop injectable versions of various drugs has allowed for collaborations with drug companies such as Roche, Johnson & Johnson, and Pfizer.
Merck, the pharmaceutical company, is the developer of the blockbuster drug Keytruda, which has market dominance backed by patents set to expire in 2028. To extend its lifetime (and extend the revenue stream, which is expected to generate nearly $30 billion annually), Merck is working on an easier-to-administer, injectable version of Keytruda (still in clinical testing, with an expected launch by early 2026). To develop the injectable version, Merck partnered with South Korea-based biopharmaceutical company Alteogen, a competitor of Halozyme, also using a variant of the hyaluronidase family of enzymes.
Realizing that Halozyme’s patents may pose a threat to injectable Keytruda, Merck recently filed petitions with the PTAB, effectively admitting these patents might be a problem for them. Merck claims that Halozyme’s relevant granted patents are too "broad" and therefore should not have been allowed, seeking to invalidate these claims and remove the potential risk of infringement.
The practice of using the PTAB as a way to remove potential IP risks is becoming more common, though it draws controversy and criticism from lawmakers. Even though PTAB proceedings are usually faster than U.S. court proceedings, the battle over these patents is expected to be heated, with major revenues at stake.
How To Protect Patents from Post Grant Challenges
A PGR can challenge a patent's claims or validity. The basis may include lack of novelty, obviousness, written description, enablement, indefiniteness, or ineligible subject matter. The best way to avoid PGRs is to beat them in advance with a great drafting process covering base IP concepts and patents on through to prior art research. And conduct strategic analysis during the patent drafting process to understand the patent’s strengths, or weaknesses relative to competitors.
The inventor’s IP protection journey does not end with the patent grant. In many cases, the patent grant is the formal beginning to a period of IP management that may last the lifetime of a product or business. The current quality of patent examination and drafting results in a high ratio of patent claim invalidation during litigation (whether in PTAB or in court).
Better drafting of patents – by taking into account all prior art with careful review of all potential novelty issues – is critical. So is a continuous review of freedom-to-operate and potential IP competition and risks. Executing these steps requires a new approach and new tools that leverage large language models and modern approaches to IP.
To protect against invalidation claims, IP holders and inventors are applying new technological methods to three key stages in their IP lifecycles.
1. Start the IP protection journey strong. Use concept ideation to avoid losing time and money at later points in the IP lifecycle.
2. Preserve the concept with fast and efficient patent drafting. Draft patents with AI support that applies prior art research and real-time freedom-to-operate (FTO) analysis.
3. Stay up to date on your IP landscape with real-time updates on competitors and risks.
Such tools can withstand the severity of the patent examination process and provide real business value that aligns business strategies with IP strategies.
The tools you need to successfully protect your IP already exist, and you’ll be surprised how fast you can benefit from them. Try senseIP for yourself!
