Biopharma companies working with the microbiome are running into patent obstacles due to the difficulty in using the system to protect naturally-occurring substances.
Protecting intellectual property is a priority for companies in the life sciences industry due to the significant revenue potential. However, companies that focus on the gut microbiome are running into problems in attempting to protect their own work.
Citing legal experts, the Boston Business Journal reported this morning that companies are facing complications when it comes to protecting their microbiome research due to the problems in patenting naturally-occurring substances. Drug manufacturers depend on patents to protect their revenue streams from competition. Many companies have gone to great lengths to establish a thicket of patents around the drugs that generate the most revenue, such as AbbVie and the protection around Humira, which brought in $20 billion last year. Other companies, such as Allergan, have attempted unusual legal maneuvers, such as the attempt to circumvent patent laws by selling the patents for Restasis to the Saint Regis Mohawk Tribe in New York. The company made the move as part of an attempt to take advantage of the Mohawk tribe’s sovereign immunity in hopes it would shield the drug from challenges to Restasis patents.
But with difficulties of patenting the microbiome, companies in that sphere, such as Seres Therapeutics, Ubiome, Merck and others, are finding other ways to protect their intellectual property, the Journal reported.
The first method is called non-natural selection. As the Journal explains, the microbiome companies are protecting their methods by filing for protection for treatments that combine natural microbes with other bacteria they do not mix with, or using the microbes in methods not found in nature. Another non-natural method is by using synthetic microbes, such as those developed by Gingko Bioworks, the Journal noted.
The second method to protecting microbiome research is to keep part of it secret. David Resnick, an attorney specializing in intellectual property, told the Journal that companies are simply not including some aspects of the manufacturing process in patent filings in order to protect them. Resnick said it’s similar to what Coca-Cola has done with its soft drink formula.
The third method that companies are using focus on patents for parts of the procedure they use in applying the microbiome research. By focusing on using patents to protect the application process, versus the microbes themselves, companies can establish barriers to defend their revenue streams. This method is similar to protections surrounding gene therapies, the Journal noted, “controlling when and where the micro-organisms work.”
