New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

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The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is a national effort to dramatically accelerate efforts to prevent, diagnose and treat cancer that take advantage of recent advances in molecular medicine and information sciences. This initiative is unique in its emphasis on public and private collaboration:

“The Cancer Moonshot aims to realize this promise by leveraging public and private efforts focused on building a system in which patients, researchers, and clinicians can seamlessly share information on treatments and outcomes to accelerate research, guide treatment decisions, and improve cancer outcomes for people across the Nation, and ultimately the world.”

Report at page 2.

Five Goal Approach

The Report, authored by the Moonshot Task Force, noted the need to have an organizational framework for addressing and uniting efforts to reach the goal of improving cancer diagnosis and therapy. Five goals emerged, each of which is noted to be critical to the overall mission, but also intended to build on and augment the success of the other goals. Report at page 5.

Strategic Goal 1: Catalyze New Scientific Breakthroughs

New scientific breakthroughs will be accelerated by: 1) promoting interdisciplinary approaches for elucidating the biological mechanism underlying cancer onset and treatment; 2) aligning research and care as a seamless and iterative process; and 3) maximizing the collection and research use of longitudinal data and biospecimens.

Strategic Goal 2: Unleash the Power of Data

A stated goal of the Task Force is to maximize access to and usability of data now available due to advances in genomic information and health record information.  This will be achieved by: 1) enabling a seamless data environment; 2) supporting open publication and storage platforms; and 3) developing a workforce that can take advantage of the open and connected environment.

Strategic Goal 3: Accelerate Bringing New Therapies to Patients

New effective therapies are the ultimate goal of the President’s initiative. The Task Force seeks to remove impediments by: 1) finding efficiencies in regulatory review and licensing processes; 2) enhance data sharing and incentivize pre-competitive collaborations; and 3) strengthen oncology clinical research.

Strategic Goal 4: Strengthen Prevention and Diagnosis

Cancer prevention and diagnosis can be strengthened by: 1) promoting public access to health programs, policies and outreach; 2) gaining a better understanding of the environmental determinants of cancer; and 3) enhancing cancer screening and testing.

Strategic Goal 5: Improve Patient Access and Care

Strategic goal 5 seeks to build on the improved access to health care provided by the Affordable Care Act. The Task Force seeks to identify areas with the greatest potential for meaningful patient impact by: 1) improve efficiencies of current programs; 2) improve cancer prevention, treatment and quality of care by applying current knowledge into workable policies; and 3) ensuring each patient receives quality care.

Creating New Paradigms

The Report sets out a blueprint with a series of activities to accelerate gains for cancer diagnosis and therapy – that is, to achieve ten years of progress in five. The Report summarizes the aspirations, conceptual and practical, that can be achieved:

“Ultimately, through the creation of new paradigms for generating, sharing, and integrating research and clinical data to enhance patient care, the Cancer Moonshot can accelerate the delivery of effective cancer prevention strategies, diagnostics, and treatments to patients in communities around the world.”

Report at page 29.

Inherent Disclosure Satisfied Written Description

In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35 U.S.C. § 112 (written description) when the partial sequence is combined with other identifying characteristics of the protein.

A Purified and Isolated TNFα Binding Protein

Yeda Research and Development Co., Ltd. (Yeda) appealed two decisions by the U.S. District Court for the District of Columbia, that were in turn appeals of two decisions by the USPTO Board of Patent Appeals and Interferences, regarding Yeda’s allegation that Abbott Gmbh & Co. KG’s (Abbott) U.S. Patent No. 5,344,915 entitled “Proteins and Preparations Thereof” (‘915 Patent) is invalid as anticipated by an intervening prior art reference. Yeda and Abbott did not dispute that the reference anticipated the claims if the claims were entitled to its earliest priority.

The ‘915 Patent, was filed on September 26, 1991 and claims priority to two German applications, P39 15 072 (the ‘072 application), filed on May 9, 1989 and P39 22 089 (the ‘089 application), filed on July 5, 1989.

The ‘915 Patent issued with three claims. Claim 1 was determined to be representative:

  1. A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence

Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu

where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

Inherent Disclosure Can Provide Adequate Written Description

Prior to addressing the substance of the challenge, the court first reviewed the legal standard for written description. Citing its en banc decision Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010), the court held that for the claims of an application to benefit from a priority application’s filing date, the claimed invention must be “disclosed in a way that clearly allows a person of ordinary skill to recognize that the inventor invented what is claimed and possessed the claimed subject matter at the filing date.” Id. at 1351.

Yeda argued that to gain the benefit of the earlier application’s filing date, Abbott must show that at the time of filing the priority application (here, the ‘072 application), a person of ordinary skill in the art would have understood that the claimed protein contained more than the partial sequence disclosed in the ‘072 application, i.e., the additional amino acids described in the ‘915 Patent specification. Abbott disagreed and argued that the ‘072 application need only describe and enable the claimed protein, and that a protein can be adequately described when a partial amino acid sequence is disclosed along with other biological characteristics.

The court agreed with Abbott, explaining that under the doctrine of inherent disclosure, “when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.” Slip Op. at 6. The court determined that the doctrine applied because it was “undisputed that the invention described in an earlier application was the exact invention claimed by the later patent.” Slip Op. at 7.

Finally, the court rejected Yeda’s argument that Abbott cannot rely on inherent disclosure on the ground that the inherent limitation cannot be material to the patentability of the invention. Yeda argued that the amino acids absent from the priority application are material because Abbott relied upon their absence to distinguish prior art during examination. During examination, the claims were rejected on prior art that disclosed a protein with the same source, weight, and function of the protein claimed in the ‘915 Patent. The court disagreed, noting that Abbott’s response did not rely on only the information absent from the priority application and that the sequence disclosed in the priority application was sufficient to distinguish the prior art.

Adequate Written Description

The court’s decision is a reminder that there is more than one way to describe an invention to satisfy written description, and, as here, to obtain the benefit of an earlier filing date. Automated DNA sequencers have simplified the sequencing of proteins such that it is common for an application disclosing a protein to disclose its complete amino acid sequence. Nevertheless, where a prior application discloses the same protein as the later filed application, and the prior art application provides sufficient description to characterize the protein and distinguish the prior art, along with a description of how to obtain it from its biological source, the prior application supports the later filed application. Of course, should Abbott assert the claim against an alleged infringer, the separate question of whether the claim is patent eligible as required by 35 U.S.C. § 101, would be an primary issued for consideration.

Personalized Medicine: Insights Into Current Legal Issues

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Guest Post by:  Nate Beaver, Esq.; Gary Koch, Esq.; Antoinette Konski, Esq.; and Judy Waltz, Esq., Foley & Lardner, LLP.

In his January 20, 2015 State of the Union address, President Obama brought to the nation’s attention the promise of personalized medicine when he announced the Precision Medicine Initiative (the “PMI”). In announcing this initiative during his address, which was to be funded with $215 million in the President’s 2016 budget, the President gave many in the nation their first hint of the tremendous benefits to be gained by physicians being better able to tailor medical treatments to individual patients. This focus on the unique attributes of each patient – the patient’s environment, lifestyle, and, most notably, genetic characteristics – allow targeted therapies to be deployed that are more likely to be efficacious, less likely to lead to adverse side effects, and, in many circumstances, more cost-effective for both the patient and society at large than current approaches to many different illnesses. Continue reading this entry

USPTO ANNOUNCES CANCER MOONSHOT CHALLENGE

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The USPTO announced a public challenge in support of the National Cancer Moonshot Initiative. The USPTO is asking the public to investigate and leverage the intellectual property data within the USPTO and combine it with other economic and funding data (e.g., SEC filings, FDA reporting, National Science Foundation grants and other funding sources) to “reveal new insights into investments around cancer therapy research and treatments.” Issues that may be explored include the peaks and valleys in the landscape of cancer treatment technologies, insights revealed by correlating R&D spending/funding to breakthrough technologies, and whether trace studies of commercially successful treatments from patent to product would informative.

A workshop will be held on Thursday August 25th, 2016 to assist participants with the challenge. The challenge concludes on September 12th and winners will be announced on September 26th, 2016.

The USPTO hopes that the information gleaned from the challenge will support cancer research and the development of new commercialized therapies. As noted by the office “[t]his will empower the federal government—as well as the medical, research, and data communities—to make more precise funding and policy decisions based on the commercialization lifecycle of the most promising treatments, and maximize U.S. competitiveness in cancer investments.”

 

Ariosa Loses Verinata Patent Challenge

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Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board (PTAB) concluded that Petitioner Ariosa Diagnostics (Ariosa) failed to demonstrate the unpatentability of challenged claims 1-30. Ariosa Diagnostics, Inc. v. Verinata Health, Inc., IPR2013-0027/-00277 (PTAB Aug. 15, 2016).

U.S. Patent No. 8,318,430

The decision is the latest in a long-running challenge by Petitioner Ariosa seeking two inter partes review of the claims of U.S. Patent No. 8,318,430 (the ‘430 Patent). Ariosa initially sought review of the ‘430 Patent on the basis of three prior art documents:  Shoemaker,[1]  Dhallan,[2]  and  Binladen.[3] After trial and oral argument on the original petitions, the PTAB issued a Final Written Decision concluding that Petitioner Ariosa had failed to demonstrate by a preponderance of the evidence that all claims of the ‘430 Patent were unpatentable over the combined teachings of Shoemaker, Dhallan, and Binladen. Ariosa appealed to the Federal Circuit.[4] In Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015), the Federal Circuit noted in its review that the PTAB might have erred by failing to consider an additional piece of prior art, namely an Illumina Brochure for the Illumina Genome Analyzer, “‘simply because the brochure had not been identified at the petition stage as one of the pieces of prior art defining a combination for obviousness.'” Decision, page 4, quoting Ariosa at page 1365. The Federal Circuit vacated the PTABs finding of non-obviousness and remanded the case to allow the parties to brief how the PTAB may have overlooked the relevance of the Illumina Brochure.

Patentability of the Claims

On remand the PTAB again determined that Petitioner failed to establish the unpatentability of the ‘430 Patent claims from the combined teachings of the cited references, including the teachings of the Illumina Brochure. Importantly the PTAB stated that:

Petitioner, however, provided no further explanation of the combination in the Petition, such as a reason with rational underpinning as to why the ordinary artisan would have combined the references to arrive at the method of the challenged claims, but only presented a claim chart demonstrating where the limitations of each challenged claim could be found in the prior art.

Decision, page 16.

The decision serves as a cautionary tale to patent challengers to not only map the elements of the claims to the prior art but also to clearly articulate the rationale why the art would be combined by one of skill in the art to arrive at the claimed invention.

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[1] Shoemaker et al., Pub. No. US 2008/0090239 A1, published April 17, 2008 (Shoemaker).

[2] Dhallan, Patent No. US 7,322,277 B2, issued February 19, 2008 (Dhallan).

[3] Jonas Binladen et al., The Use of Coded PCR Primers Enables High-Throughput Sequencing of Multiple Homolog Amplification Products by 454 Parallel Sequencing, 2 PLOS ONE 1-9 (2007) (Binladen).

[4] The procedural history has been abbreviated for the sake of brevity. The appeal was a consolidation of two proceedings initiated by Ariosa at the PTAB.