A Myriad of Tips on Biotech Patent Prosecution

“It’s never good news when your area of the law is on 60 minutes,” says Courtenay Brinckerhoff, partner at Foley & Lardner LLP at the 2013 AIPLA Annual Meeting. It’s no secret that the Association for Molecular Pathology v. Myriad Genetics case had more than its fair share of media buzz. The decision, holding that isolated DNA was not patent eligible, left many of us wondering how to best address the needs of our biotech clients going forward.

First, a quick recap on Myriad for those of you that have been busy focusing on the fallout of CLS Bank v. Alice Corp. (For more on CLS Bank see here, here, here and here.

The main claims at issue in this case are the isolated DNA claims. Claim one is broad enough to cover naturally occurring DNA, and claim two is specific to synthetic DNA. In 2010, the district court came out with a decision holding that DNA was not patent eligible subject matter, which was a bit of a shock to us. Most of the rationale was focused on the idea that DNA embodies information, and regardless of what the actual molecule looks like, Myriad’s claim is for that defining characteristic. The case went up to the Federal Circuit where former chemist Judge Lourie held that technically the isolated DNA is different than natural DNA, because you have to break the covalent bonds to isolate the methylated gene. There were, of course, also policy reasons to uphold the claim like the reliance of the biotech industry on the USPTO already having granted these sorts of patents for nearly 20 years.

In the dissent, Judge Bryson, looking at things through the lens of a molecular biologist, focused on the fact that genes encode a protein, finding that isolation was an irrelevant distinction. He did however uphold the claims to the cDNA, which is the synthetic sequence, covered by claim two. Myriad went up to the Supreme Court, who vacated the Federal Circuit’s decision and remanded the case back down, in light of the Mayo v. Prometheus decision. The Federal Circuit issued another decision, which pretty much repeated their original decision. Then earlier this year the Supreme Court tackled the issue and came to a unanimous decision. “It’s interesting while Federal Circuit can’t agree on §101 issues, the Supreme Court has been unified– perhaps not in the right direction.” says Brinckerhoff.

Their holding was that natural occurring things are not patent eligible, and isolation isn’t enough to make the naturally occurring DNA into a patent eligible invention, regardless of the hard work and money Myriad may have put in. They ruled that CDNA however is a synthetic sequence, which can be non-natural and therefore can be patent eligible. Drawing this line between something that’s natural and something that’s not presents unresolved questions about the eligibility of proteins, antibodies, small molecules, and so on. We’ll have to see how far Myriad is extrapolated to answer many of these questions.

On the method claims, the test, derived from Prometheus, is whether the claims add enough to a natural principle/law of nature/ natural phenomenon to make them go beyond claiming just the natural principle/law of natural/natural phenomenon alone and to ensure practical application. If they do and if that extra stuff isn’t just routine or conventional steps known in the field, the claims are patent eligible. So, are diagnostic method claims acceptable, or what about personalized medicine claims outlining which drugs work better for specific patient populations? How about a kit with instructions?

We can look to the PTO Guidelines and to the case history after Prometheus to give us a some tips on what may not be eligible and how put our best foot forward when preparing biotech process patent applications.

1. Don’t give up. “I think first and foremost our advice [to biotech clients] is not to give up. We were surprised after the Prometheus decision the types of claims that we were able to obtain from patent office,” says Brinckerhoff. Of course, claims could always be subject to challenge in court later on. However the Supreme Court’s holdings for all the cases in this field are based on the view that categorical rules are to be avoided, says chair of AIPLA amicus committee Jerry Selinger. So, until we get a little more case law to determine a trend, there’s little harm in trying.
2. Look out for things that are not patent eligible on their own. Abstract ideas, naturally occurring compositions, natural principles and previously unknown natural phenomenon are not patentable but application of any of these to a new, useful end passes muster under § 101. Similarly, a patent on a new drug or a new way of using an existing drug would not have any problems.
3. Focus on having a step that’s not routine or conventional. When you’re in that routine or conventional step test, it’s important to remember that it doesn’t have to rise to the level of non-obviousness. Analysis of §101 precedes and is independent of the analysis of §103. As long as you can show steps that are novel you should be able to pass by that aspect of it.
4. Define your unconventional step narrowly and specifically. For example, ‘it was not routine to look for this marker in this patient population at risk for this condition.’ An instruction that tells doctors to “apply” applicable natural laws when treating their patients would not work.
5. Relatedly, don’t try to add fluff to make an invention patent eligible. You can’t just tack on meaningless steps onto a natural law or phenomenon to make it patent eligible. For example, “recording the diagnosis on a chart” would not make your invention eligible.
6. Limiting a law of nature to a particular field will probably not work. This comes from Parker v. Flook, where limiting a formula for use only in catalytic conversion systems was not sufficient to make the claim patent eligible.
7. Passing the machine-or-transformation test is probably still a good idea. “While the court is not going to rest its hat on the machine-or-transformation test, if you don’t pass it you’re probably in trouble,” says Brinckerhoff. All that being said, even though the machine-or-transformation test does have its imperfections and is not the sole test, so you’re not hopeless if you can’t fit into that framework. *Bonus points for describing the relationship between the machine/transformation and the natural principle. For example, “the parts of an internal combustion engine apply the concept of combustion to produce energy” or “using ionization in a manufacturing process” would both be patent eligible, according to the PTO Guidelines.
8. Write a spectrum of claims. Think of the invention from as many different angles as possible and write as many different types of claims as you can. This is a good practice for claim drafting that dates back to the days of O’Reilly v. Morse. If Morse had only bothered to write one claim for electromagnetism instead of eight claims, we may not have had the telegraph. When we talk about the biotech world, the case is no different. A spectrum of claims may ensure you get some of the specific ones, if the broad ones are rejected.
9. And finally, differentiate your claims from those in Prometheus as much as you can. The big problem in Prometheus was that the drug was around, and people were already studying metabolite. It was really just the dosing “sweet spot” that was novel. Also, not having specific application hurt. Following Prometheus and Myriad there was an unpublished decision, Intema, that rejected the claims because of similar problems. In that case, there were diagnostic method claims for determining the risk of Down’s syndrome. There were measuring, determining, and comparing steps. Much like the Prometheus claims, here a person also makes a decision based on information about levels of things he determined, and then he correlates that to the risk of a condition. Not surprisingly the court said this is a preemption issue. “The claim also didn’t have any specifics as to what factors you were looking for and what levels you were looking for, so that may have colored the court’s decision also,” says Brinckerhoff.