Coming off a year that saw a record number of new drug approvals, significant scientific breakthroughs and a year-end tax reform package that both significantly lowers corporate taxes and provides the long-awaited tax repatriation holiday, it’s not surprising that biotech investors, executives and advisers were in a good mood as they gathered in San Francisco
Fenwick corporate lawyer Julia Forbess discussed biotech investment and financing trends with the BIO Buzz Center at the 2017 BIO Investor Forum.
“For 2018, we’re still expecting to see investment in core areas—oncology, orphan drugs and neurology. One thing that could be new is the number of tech investors interested in diagnostics and other…
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.
It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the Center for Devices & Radiological Health released an action plan about its Digital Health Program and posted a notice for comment for a Software Pre-Certification Pilot Program.
The pilot program is a first step in the FDA’s reimagined digital health product oversight approach. What makes it stand out from the FDA’s prior regulatory approach is its aim "to develop a new approach toward regulating this technology – by looking first at the software developer or digital health technology developer, not the product."
Under its firm- and developer-based approach, the CDRH could "pre-certify" eligible digital health developers who "demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review."
In his blog post, the FDA’s Scott Gottlieb announced that in August companies can submit a statement of interest that includes the qualities listed above and request participation in the pilot to FDAPre-CertPilot@fda.hhs.gov. The FDA’s Digital Health Team will evaluate submissions and select companies that reflect the broad range of software developers later in the month. “A critical component is that we will include small and large companies, traditional and non-traditional medtech companies, and products that range in risk,” Gottlieb said in his post. (Read more about how the CDRH is recruiting participants to the pilot program.)
The FBI arrested Shkreli in December 2015, and the U.S. Attorney’s Office for the Eastern District of New York charged him with securities fraud, securities fraud conspiracy and wire fraud conspiracy for interrelated schemes “to ensnare investors through a web of lies and deceit.” The schemes, allegedly executed over a five-year period, involved…
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.
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 Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views of the Solicitor General (CVSG).
The case involves issues central to the application of the Biologics…