Pace maker

The current level of Section 101 litigation shows that this area of law is still evolving. Mika Reiner Mayer, new partner at Cooley in Palo Alto, explains

Congratulations on your new role. Where do you see your focus being in terms of patents owners in the next few years?

Thank you, I am very excited to be at Cooley. My practice has always focused on the life sciences sector, and Cooley has one of the largest life sciences practices of any firm in the world. I am looking forward to helping to continue to grow that practice by working collaboratively with all the different practice groups we have here.

As for the next few years for patent owners, it’s a very dynamic time. In the life sciences sector in particular, we have seen an incredible convergence of traditional life sciences with high tech and I expect to see this trend continue.

Technologies have emerged ranging from sensors on pills for patient compliance to smart contact lenses to measure glucose, and the pace of innovation seems to be ever increasing.

I feel fortunate to be able to work with the people on the front lines in these fields.

Has the introduction of inter-partes review proceedings become a help or a hindrance to medical device makers and pharma patent owners?

While we are seeing inter-partes reviews with increased frequency in the life sciences space, they have not yet hit the fever pitch they have in other industries such as software and high tech. In those industries, the volume of litigation is extreme and corresponding inter-partes reviews have become a commonplace litigation strategy to counteract non-practicing entities.

Over time, I expect to see more inter-partes reviews filed in the life sciences space, but I think it is unlikely the numbers will ever reach the numbers filed in the high-tech space, where historically, there is far more litigation.

We have also seen abusive inter-partes review proceedings in the pharma space, where non-practicing entities file inter-partes reviews in an effort to manipulate stock price and lower company value. It will be interesting to see what comes of the efforts to enforce standing requirements to thwart this practice.

Now that it’s been five years since passage of the American Invents Act, have US courts and the USPTO clarified and improved the system?

Since the passage of America Invents Act in 2011 and the creation of the Patent Trial and Appeal Board (PTAB), which oversees inter-partes reviews, it feels like the US Patent and Trademark Office (USPTO) has been reaching out more to the patent community.

With road shows, satellite offices, participation in various conferences, and solicitation of input and feedback, it appears that the USPTO is trying to encourage additional community involvement and engagement. From my perspective, I think it’s having a positive effect on the overall patent process.

The US Supreme Court recently declined to hear Sequenom v Ariosa, while the Federal Circuit has also reaffirmed the two-part test for eligibility and restored a patent directed to natural phenomena—is the Section 101 patentability debate over as far as natural phenomena and diagnostics are concerned?

I think the fact that there have been so many Supreme Court and Federal Circuit decisions attempting to clarify the Section 101 standard shows that this area of law is still evolving. District courts have been applying the current standard differently as well, so it doesn’t seem like this area is well-settled just yet.

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