A few examples from the generic pharma sector are helpful to understand the value a good patent portfolio can bring to business. From early 2000, until almost 2012, we saw Teva Pharma create and assert patents related to crystal forms and processes for active ingredients, against potential competitors/players, and make money through licensing/royalty payments. A few examples will help.
In 2021, Pfizer’s Chantix® (varenicline tartrate) was discontinued due to presence of impurities. Endo/Par, with a generic of varenicline, remained the sole player on the market. They created a patent portfolio (US11717524, US11602537, US11779587) around their varenicline product, which had acceptably low impurities, and asserted the same against potential competitors. The granted claims of this patent portfolio are such that a competitor cannot design around these and still obtain a regulatory approval. As a result, the competitors are compelled to invalidate the patents, which is always an uphill task. This can therefore create a good source of licensing/royalty for Endo/Par.
Cipla, an Indian pharma major, had strategically obtained a patent that broadly covers a pure form of levalbuterol tartrate (the original process claims were amended through a reissue application to obtain broader protection). This was then asserted against Sunovion for infringement caused by sales of Sunovion’s Xopenex HFA, a product that made billions for Sunovion. A settlement followed, and it would only have monetized the patent for Cipla.
Another example is that of Janssen benefitting from Momenta patents covering processes which control post-translational modifications (US9475858, US8852889, US9217168, US9663810) – patents that Janssen inherited from their acquisition of Momenta, and asserted against biosimilars to Stelara®. These patents are seemingly difficult to design around, and have been helpful to Janssen in protecting their USD 6 billion+ Stelara® franchise. Without these patents, Janssen may not have had sufficient arms to file for preliminary injunction, and settlements thereafter.
Yet another example from the biosimilars world is that of Coherus initiating a litigation against Amgen, asserting infringement of four Coherus patents (US10155039, US10159732, US10159733, US10207000), which relate to "stable aqueous compositions comprising adalimumab as the active ingredient and other components as inactive ingredients.” Amgen was the first biosimilar to Humira® and had obtained a launch date of January 2023, upon settlement with Abbvie, and Coherus has a launch date of December 2023. While details of their settlement are not public, it can be safely assumed that Coherus used this to their advantage in US and Europe.
Interesting patent portfolios can be seen from Azurity pharma, for example, especially the patents covering their products Katerzia, Epaned, Firvanq kit (see Orange Book patents for these products). Each product is covered by at least 4-7 patents, all of which expire on the same day, but have different claim scope, and have been effective in creating barriers for generic competition.
Typical patents we see are those covering formulation and its aspects, drug-device combination, purity, stability, process, crystal form, and the like. But it is worth considering filing claims around aspects that are important – and closely related to – regulatory aspects, business development issues and market dynamics. The patent drafting team, apart from the R&D, must understand the needs of the patient, must know and own the market, and must carefully understand the competition and its pain points. An early mover advantage will always be helpful. Strategic patenting raises barriers to competition, making it very difficult for competitors to overcome them, and is not considered to be anti-competitive – it is a valid tool for protection against competition, value creation.
Monetizing IP effectively is the need of the hour. Do not just be happy with the grant of a patent – see what you can do next. More patents covering same invention differently, or covering different aspects, are important in leveraging your position. It is also equally important to create different IPs for the product, such as trademarks, trade dress. Look out for partners, parties to out-license to, undertake policing, track your competition, pitch to investors, and use the patent portfolio to generate revenue to fund R&D.
