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How Companies Can Extract Value from Expired Drug Patents

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Copyright © DrugPatentWatch. Originally published at https://www.drugpatentwatch.com/blog/

We happen to be living in a time of rapid and intense digital transformation, when computing power, data storage, and communication bandwidth have coalesced to produce technological leaps.

The greatest scientific breakthroughs are built upon lessons learned in the past.

Similar technological revolutions happened in the past, like with the commercial availability of penicillin in the 1940s and the standard model of physics that resulted from Albert Einstein’s papers on relativity and quantum mechanics in 1905.

New technological revolutions begin all the time, and the new research revolutionaries stand on the shoulders of those who made breakthroughs in earlier eras. After all, you don’t need to reinvent the wheel to make a self-driving car. Hence, older research and patents in the public domain can be invaluable to innovative breakthroughs of today and tomorrow.

Finding Expired Drug Patents

In pharmaceuticals, companies can learn about compounds and delivery methods others have developed through their patents and patent applications. Expired and lapsed patents (those for which maintenance fees have not been paid, but which have not run their 20-year patent term) can offer tremendous intelligence about competitors, and also about what has not been developed and disclosed through patents.

There are several online search tools that help the curious learn which patents have entered the public domain. The United States Patent and Trademark Office (USPTO) has a full-text and image database you can search, optionally selecting the time frame for patents that have passed their 20-year term. Google Patents is a search engine for patents, which can also be set for a time frame appropriate to expired patents, and NASA offers a search engine for its own public domain patents.

Example Use Case

Say a pharmaceutical company wants to solve a problem by developing a new small-molecule drug. A patent search is mandatory for obvious reasons of avoiding infringement, but researching expired drug patents makes sense as well. Others may have done work on the problem that can be valuable in terms of avoiding mistakes. If technology already exists and is available in the public domain due to patent expiration, significant R&D resources may be saved. In pharmaceuticals, with its especially complex regulations, thorough searches through expired drug patents can help bring products to market at a far lower cost than would be possible otherwise.

Expired patents can inform you if someone else has already done work toward solving your problem.

Diligence Still Necessary

Abandoned drug patents are trickier to work with than expired drug patents are. Should you, for example, create a new product based on information in an abandoned drug patent, the patent owner has 24 months in which to revive the patent by paying any fees that have accrued. If the original owner does this, there’s still a good chance you’ll retain your rights to sell the product, but there are no guarantees, and a legal challenge certainly won’t help your launch go smoothly.

Furthermore, it is critical to do searches on patents for products similar to those covered in expired drug patents. The original patent owners may have filed patents for highly similar inventions, and you run the risk of infringing on those patents. Many companies protect their interests further by filing continuation applications, which are new and complete patent applications that are derived from applications filed earlier. These so-called “child applications” can complicate the legal environment if you are building on existing research.

Patents as Teaching Documents

Patents are designed to communicate knowledge. Indeed, they can serve as their own form of technical literature. Patent expiration, rather than diminishing the value of the information contained in a patent, could, in fact, increase its teaching value because of greater utility to new researchers using and building on work that has already been completed.

Expired drug patents are no exception. However, it’s essential that anyone interested in building upon research contained in expired drug patents be vigilant in searching for closely related patents that may still be active. And special care is needed when working with information in lapsed, unexpired patents in the event the original patent holder decides to pay the necessary fees and revive the patent before it expires.

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