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Life science strategies in the US



Alice O'Donkor, London


At Managing IP’s European Life Sciences Forum, Finnegan’s Jennifer Roscetti and Erin Sommers covered issues of patent eligibility in the US and tips for IPR proceedings

The US patent litigators led the panel at Managing IP’s first European Life Sciences Forum in London, which was held at Le Méridien Piccadilly. Throughout the day, in-house and private practitioners from across the continent shared updates on topics including final preparations for the UPC, an analysis of notable SPC cases from the past year and key risks for life sciences clients with consideration to Brexit.

To begin, Finnegan’s Jennifer Roscetti and Erin Sommers offered a US perspective on patent eligibility as defined by Section 101 and discussed the relevance of recent PTAB developments. The panel highlighted the efficacy of the Mayo/Alice two-step test and encouraged delegates to take advantage of advice offered by the Federal Circuit on how to implement the framework.

Developing your claim

Roscetti reviewed the Federal Circuit’s April 2016 decision in the  Genetic Technologies v Merial  case, in which the Court affirmed that diagnostic method patents held by Cleveland Clinic were "directed to ineligible subject matter". This case raised a number of concerns for the Federal Circuit, one of them addressed the defendant’s claim regarding the lack of pre-emption. 

Jennifer RoscettiThe rationale behind the court’s decision, Roscetti told delegates, illustrates its concern about a claim hinged on issue of pre-emption, which could impede the use of the same type of technology for patentees "developing lots of uses, as opposed to one specific area".

In affirming the decision of the district court, the Federal Circuit also took issue with the fact that the claim "took the correlation between the coding regions and the non-coding regions without adding significantly more". Namely, the amplifying step and the analysing step had already been revealed in prior art and were not required in the narrative.

Sommers urged delegates to learn from past Federal Circuit cases, particularly if "in looking at your claim, the patent office or a defendant in litigation can argue that your claim elements start and end with natural law of natural phenomenon and nothing more".

"Considering that law, if you have these methods that are routine in nature, they are likely to end up being ineligible subject matter," she added.

The panel highlighted the importance of considering whether the method was "occurring in nature before, even if it has not been recognised". Further to this, delegates were also encouraged to consider searching for "something more" to circumvent questions of patent eligibility altogether.

Make use of your contacts

Sommers added: "When you are searching for something more, the more that you can put that into the claim language from the get-go, that can help you have a conversation earlier on with the examiner and prosecuting to see where more than one issue is coming up, and what exactly you need to add to your claim to get outside the ineligible subject matter."

Erin SommersParticularly during prosecution, says Roscetti, if you get a 101 rejection: "It is important to communicate directly with the examiner and perhaps pull one specialist from each art. The USPTO keeps releasing new guidance and examples as to what is eligible and ineligible. Have a conversation with the examiner to make sure that you are trying to marry yourselves with the examples that have been provided."

In Cleveland Clinic v True Health in June this year, the Federal Circuit concluded that there was no infringement of method of treatment patents. While the Federal Circuit’s decision was not in favour of Cleveland Clinic or particularly ground-breaking in itself, Roscetti notes: "The important thing here is that True Health, the testing facility, never even challenged the patent eligibility of those method of treatment claims and they were also linked to the idea of correlating myeloperoxidase with cardiovascular disease." This outcome was considered a favourable outcome for developers of diagnostic methods who could face similar hearings in the future. In addition, Roscetti advised companies developing diagnostic methods to consider types of conventions they could introduce to the subject matter to present their patents as eligible.

It was also observed that the district courts are increasingly reliant on the Alice/Mayo framework in their decisions. Examples of patent ineligibility can be found in Roche Molecular Systems Inc v Cepheid and Esoterix Genetic Labs LLC v Qiagen Inc. Decisions of patent eligibility can be seen in Vanda Pharm Inc v Roxane Labs Inc and Idexx Labs Inc v Charles River Labs.

The future of inter partes challenges

The panel used a number of studies to illustrate the growing rate of biotechnological/pharma patents being challenged at the Patent Trial and Appeal Board in the US. Between September 2012 and March 2017, the USPTO reported that 296 of 456 petitions (63%) originated from the biotechnology/pharma field. According to Finnegan’s research on biotechnological/pharma inter partes review (IPR) petitions filed, 65% of petitions are "granted in whole or in part across different types of claims".

Oil States Energy Services, LLC v. Greene’s Energy Group was said to be an important case to follow, for its potential bearing on future proceedings. As private rights, under the Constitution, need to be adjudicated by a judicial branch and public rights are adjudicated before an executive branch, the case considers the question of whether IPR violates the Constitution by "extinguishing private property rights through a non-Article III forum without a jury". As put by Roscetti, the discussion of private right versus public right will be the focus and main debate of the Supreme Court: "It’s about sensational as patent law gets!"

The first round of briefing is due towards the end of July.


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