Industry leaders anticipate that the use of artificial intelligence in medical imaging will have a substantial clinical impact, ushering in an opportunity to significantly improve decision support in medical image interpretation. In this post, we cover a variety of promising medical imaging applications for AI and machine learning—including diagnosing cancer and brain aneurysms—as well as recent regulatory developments.

Metrics Climb

CB Insights reports that healthcare-related AI investment totaled $1.44 billion in the first half of 2019, putting investment in the space on track to surpass the prior year, in which investment reached $2.5 billion. Much of the attention to date has surrounded applications in medical imaging or radiology.

VC-backed deals and financing to healthcare AI startups, Q1'18 - Q2'19 ($M)

The National Center for Biologic Information (NCBI) reports that publications covering AI in radiology have steeply increased in recent years. Between 2016 and 2017, the number of articles published on the topic ranged from 700 to 800. That’s compared to 100 to 150 articles published between 2007 and 2008. In addition, more than half of recent articles focused on applications related to magnetic resonance imaging (MRI) or computed tomography (CT). And January saw the launch of a peer-reviewed journal devoted to AI in medical imaging: Radiology: Artificial Intelligence
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At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent applications in the areas of precision medicine and bioinformatics, disciplines that are at the epicenter of rapidly changing law on patent eligibility of software and medical diagnostic inventions. In this post, we share some of their tips for applicants in both the United States and Europe.

At the September 21, 2017 symposium, Fenwick’s Kevin Kabler moderated the panel. Sharing insights* into patent eligibility and obviousness considerations in the U.S. were speakers Marjorie Moran (USPTO) and Andrew Whitehead (Fenwick). On the European side, our guests were Georg Wimmer (EPO) and Frances Salisbury (Partner, Mewburn Ellis, UK). 

Following are edited highlights from the program.

Q: What is considered a bioinformatics invention by the EPO?

A: Examples of bioinformatics inventions can include a method of determining a genotype, or a method of diagnosing based on the presence of one or more biomarkers. Generally, bioinformatics inventions include at least one step that is carried out on a computer, where the technical purpose of the invention as a whole relates to some sort of biological or health-related aspect. These types of inventions, as long as they comprise at least one so-called technical feature—like a physical step of measuring or an execution by a computer as well as algorithmic mathematical steps—are often called mixed-type inventions.

Q: What type of considerations exist with respect to exclusion to patentability in Europe?

A: In addition to other considerations under novelty and clarity, the two most common hurdles for bioinformatics-based inventions before the EPO are the exclusion from patentability, governed in the European Patent Convention under Article 52, and inventive step, governed under Article 56. Patent applicants trying to address these two hurdles often fall victim to two pitfalls: one is insufficient detail in the claims and the other is insufficient detail in the original application.

Q: In the United States post-Alice, what are the key takeaways when addressing an eligibility challenge?

A: Our approach to addressing eligibility rejections in the U.S. is generally similar regardless of whether the application has an Alice-type rejection or a biological or diagnostic Myriad or Mayo-type of rejection. What helps get claims to patent eligibility is specificity in the claim. It is not so different from the EPO where what matters is your actual “technical purpose” of the invention and how the specificity of your claim helps achieve that technical purpose. Unlike the EPO, however, simply having such specific steps performed by a computer often is not sufficient to achieve eligibility in the U.S.

To get to eligibility, it has proven effective to tell U.S. examiners what the improvement is and provide evidence that the claims achieve that improvement. Examiners look to your specification, so specificity in the disclosure is important as well. If the application illustrates a sufficient improvement relative to the art, then often no further steps are needed. However, we do have a concern for those claims where the end result is merely the acquisition of information alone. Currently, claims along the lines of “data in, perform analysis, information out” are generally going to be difficult to obtain in the U.S. in the face of an eligibility rejection.


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Subject matter eligibility in the United States has recently become a key issue in patent law that has impacted a wide range of technologies in both the life sciences and technology industries. Despite the increased importance of eligibility, there remains a great deal of uncertainty and confusion surrounding the tests that have been implemented by the courts and the U.S. Patent and Trademark Office to assess eligibility.

Following the U.S. Supreme Court’s Mayo and Alice decisions, the USPTO adopted a divergent eligibility analysis framework as it relates to particular forms of subject matter. In particular, one key distinction that exists within that eligibility framework is an apparent “detour route” only available to products of nature — which, not surprisingly, skews heavily to the life sciences industry and is largely irrelevant to the technology industry. This “detour route” involves initially assessing whether a composition claim is “directed to” a product of nature exception via a “markedly different” test.

The USPTO Diverges in Use of the Markedly Different Test

The “markedly different” test focuses on whether claimed subject matter is structurally or functionally different relative to a naturally occurring counterpart or set of counterparts. If the claimed subject matter is different, the USPTO does not consider the claim to be “directed to” an exception, which can conclude the eligibility inquiry in the applicant’s favor. As such, the “markedly different” test serves a de facto gating function for assessing whether a claim is “directed to” a product of nature exception. Such a gating function remains (from the USPTO’s perspective) unavailable to the other exceptions based on its current guidance memoranda even though many claims in technology-focused patent applications encompass functional differences relative to the state of the art. Instead, the inclusion of a law of nature or abstract idea exception in a claim is more often than not regarded as sufficient to consider the claim as being “directed to” the corresponding exception in the context of the eligibility framework analysis.

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Responding to the Supreme Court’s request for its views, see prior post, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). 

The case involves issues central to the application of the Biologics Price Competition and Innovation Act of 2009

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Section 271(e)(1) exempts certain pharmaceutical-related activities from patent infringement, stating that “[i]t shall not be an act of infringement to make, use,

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product. This time, however, the court elaborated that such notice is required even if a biosimilar applicant fully participated in

On September 15, 2014, New York Attorney General Eric Schneiderman filed an anti-trust lawsuit against the specialty pharmaceutical company Forest Laboratories and its new owner, Actavis. In the suit, Schneiderman alleges the companies’ plans to remove from the market a soon-to-be generic version of the Alzheimer’s medicine Namenda are “manipulative” and “illegal”.

“Purely to squeeze

On October 5, the United States Supreme Court agreed to review the case Bowman v. Monsanto Co., Docket No. 11-796 (USSC 2012). The high court will be taking on the question of patent exhaustion in seeds, specifically Monsanto’s “Roundup Ready” seeds. Monsanto sells the seeds, which grow into plants resistant to the herbicide glyphosate,