Breaking down phage patentability

You may have heard through the grapevine that “phages can’t be patented”, and yet, several phage patents exist, and biotech and pharma are starting to invest in phage-based therapeutics. What’s the deal?

This week, we’re starting a multi-part issue on what the issues and possible solutions are when it comes to patenting phage therapeutics. To begin, we’re delving into a paper by Kelly Todd, Duke University School of Law J.D. / M.A.

Why are patents so important?

It costs BILLIONS and YEARS to make a drug. Often, the drug won’t even work. Why would anyone get into this business? Enter patents.

• Patents have historically allowed companies to recoup the costs of making a drug by giving the company a monopoly (for a while) so they can set their price and not worry about competitors.
• Put another way, patents are a way to incentivize HUGE investments into something by providing companies who make these investments with a fighting chance that they’ll get their money back (and make money).

Bottom line: patents protect risky INVESTMENTS

Phage therapy development needs special consideration

Developing any drug is expensive and risky. But phage therapies face an even steeper uphill battle than other drugs face. Why? Here are two reasons:

• A big reason drug development is expensive is because clinical trials are expensive, in part because they take so long. First, phages evolve over time making them tricky to work with. What's more, to show they work, you have to test them on a very specific patient group. Finding this patient group depends on sophisticated bacterial diagnostics, but quick/cheap ones don’t really exist. So clinical trials that deal with phages will likely be slower and thus more expensive than regular clinical trials.
• Phages count as antimicrobials, which people aren’t accustomed to paying much for, and which people don’t typically take for very long.

Bottom line: phage therapy development will probably cost even more than regular drugs, and these costs will likely be harder to recoup.

Phage patentability called into question

So if patents protect risky investments, and phages are extra-risky, it could be said that phage therapies are even MORE in need of patent protection than other drugs.

However, the patentability of phage therapies has been called into question. Several patents in the same category as phages have actually failed to hold up in court. This suggests that even if companies can find ways to successfully file phage patents, these patents may end up being worthless.

So phages may need protection in other ways.

Next week, we’ll continue this discussion, and talk about some possible alternative ways of incentivizing phage development. If you can’t wait until then, read Duke University School of Law J.D. student Kelly Todd’s article on phage patentability here.

Citation: Kelly Todd, The Promising Viral Threat to Bacterial Resistance: The Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives, 68 Duke Law Journal 767-805 (2019) Available at: https://scholarship.law.duke.edu/dlj/vol68/iss4/3

Thanks for reading! – Jessica <>={