Repeat After Me: My Genes are Patentable and That's Alright

By Maxxwell A.R. Chatsko - September 12, 2012 | Tickers: BMY, INCY, MYGN, PFE | 0 Comments

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The recent Association for Molecular Pathology v. Myriad Genetics patent dispute involving two genes for breast and ovarian cancer, BRCA 1 and BRCA 2, has been widely followed by the media over the last several years. According to some the case highlights a potentially devastating future where humans have no control over their very own genetic code. Even worse, they say, patenting sequences of human DNA limits academic research and delays inevitable benefits to society. While there is certainly cause for concern I believe the recent attacks on Myriad Genetics, Inc. (NASDAQ: MYGN) have been a bit overdone.

What is Patentable Material Anyway?

The first distinction to make is between the two different types of patents in play: (1) composition of matter claims and (2) method claims. In general, (1) is more valuable and easier to prove than (2). A valid composition of matter claim for a human gene is described by the U.S. Patent and Trademark Office (PTO) as:

“Like other chemical compounds, DNA molecules are eligible for patents when isolated from their natural state and purified, or when synthesized in a laboratory from chemical starting materials... The courts interpret the statutory term ‘useful' to require disclosure of at least one available practical benefit to the public.”

A method claim would be used to patent a diagnostic test, but it is often difficult to prove novelty. On August 16^th, 2012 the Federal Circuit ruled 2-1 to uphold Myriad’s composition of matter patents (BRCA 1 and BRCA 2) while invalidating the company’s method claims (diagnostic testing) because they were mere “mental steps.”

Put the Pitchfork Down

Consider the following truths. The race to discover BRCA 1 and BRCA 2 – set off by U.C. Berkeley in 1990 with evidence of cancer susceptibility protein production – would never have occurred without the incentives of a patent system. In other words, if human genes were not patentable then society may still be without these important early detection systems. Why would Myriad spend millions of dollars trying to learn everything possible about BRCA if their end technologies could be copied by an unlimited number of competitors?

While I do believe that sometimes the high costs of administrating patented drugs or diagnostic tests are fueled partially by greedy management teams, companies do have a right to reclaim hefty R&D costs. Let’s not forget that a successful drug or entity can help support R&D into future drugs and discoveries that ultimately help society. Take a look:

Source: Company websites

Myriad’s high profile case involves only two genes, while approximately 4,000 (20%) of the nearly 24,000 human genes have been patented. It seems a bit silly to lose your mind over just two of those genes (that’s potentially 0.0083% of your genome). Astonishingly, Incyte Corporation (NASDAQ: INCY) owns half of all human gene patents. Has your life been negatively altered by any of their human gene patents? (They have more problems to worry about.)

Does academic research suffer due to big corporations’ patents? Hardly. Nearly 28% of all human gene patents belong to universities, while 63% belong to private companies. Although in rare cases universities have been sued for infringement, many companies choose not to pursue litigation against research labs. In fact, more than 9,000 scientific papers have been published on BRCA genes in the last two decades. It is also important to point out that Myriad is the defendant in the case, not the plaintiff.

Lastly, Myriad’s patents on the BRCA genes are set to expire in 2015. If it was such a big issue, then why didn’t it come up in 1994 when the discoveries were made?

Foolish Bottom Line

An overhaul of patent laws is unlikely (but that’s ok). Many of the laws that govern human gene patents were created decades ago and extended to cover continually more advanced technologies. The issues surrounding “isolated” material in the Myriad case were first used to describe and successfully defend a patent of purified human adrenaline in 1906.

Despite their patina many of these laws are surprisingly adequate for current use. It wasn’t until the Human Genome Project was completed in 2001 that the U.S. PTO addressed some loose ends and clarified patents on human genes. Any questions about the agency’s confidence in current laws were dismissed last year in the America Invents Act, which made no mention of human gene patents.

When I first heard of the Myriad Genetics case a few years ago I could not believe that human genes were even patentable in the first place. But after taking a step back and researching the issue I realized that it is usually portrayed through a biased lens that intends to incite an emotional response. The fact that human genes are patentable does not deter advancements in medicine or innovation – quite the opposite really.

Did you enjoy this post? Follow me on Twitter to keep up with my future posts on energy, sustainable chemicals, and biopharmaceuticals @BlacknGoldFool.

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