Deerfield Institute

Established in 2006, the Deerfield Institute delivers sophisticated and timely market research, which enhances the insights available to the investment team and its partners. The Institute develops and analyzes data to advance understanding of innovations and emerging products, and it also informs on trends within the healthcare market. It has published important scientific findings in peer-reviewed journals to extend learnings to the scientific community and benefit public health at large—and  ultimately patients in need. The Institute is guided by Deerfield’s core values: integrity, the pursuit of objective and unbiased research, commitment to excellence, precision and accuracy.

Deerfield Institute Capabilities: 

  • Epidemiology
  • Scientific Evaluation
  • Biostatistics
  • Clinical Trial Design, Analysis
  • Intellectual Property Evaluation
  • Commercial Market Assessment
  • Market Access (Pricing, Reimbursement, Access)
  • Territory Mapping
  • Physician Targeting Plans
  • Brand Positioning and Strategic Planning
  • Forecasting
PUBLICATIONS
We publish research data to help advance healthcare and to enable researchers to have access to recent, relevant information.
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Confidentiality

Deerfield Institute believes that market research is a valuable resource to the growing healthcare industry. A critical component of this research is assuring respondents that their information is being used properly and within standard industry guidelines. Individual responses from any market research effort are kept confidential and are reported without individual identifying information. During our research process, we collect, aggregate, and analyze information from respondents in various healthcare-related fields. We then prepare reports based on these answers for the purposes of understanding market level dynamics.

When participating in Deerfield Institute market research, respondents may be asked to provide personally identifiable information (such as name, email, and mailing address). This information will only be used to provide respondents with services or information that they have requested. When preparing reports or analyzing the results of our market research, personally identifiable information is always removed and will not be given or sold to a third party without the respondent’s consent.

All Deerfield Institute research is conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

As part of our research process we seek the insight of key opinion leaders and other expert advisors in the healthcare field. Our compliance framework is designed to avoid the receipt by Deerfield Institute of confidential information and strict policies and procedures must be followed in the engagement of these advisors. All paid advisors are required to sign terms and conditions that clearly define their responsibility to not disclose information to which they have a duty of confidence.

All Deerfield participants in an advisor interaction are trained in our compliance procedures and are required to give compliance reminders to expert consultants prior to each interaction. These policies and procedures extend to all of our partners that facilitate access to our advisors.

Deerfield Foundation

An affiliate of Deerfield Management, the Deerfield Foundation is a New York City-based not-for-profit devoted to advancing innovative health care initiatives. Since 2007, the Foundation has formed 56 partnerships and invested in the advancement of children’s health, from clinics in the South Bronx to Nepal. Funds are provided through employee contributions and directly from Deerfield’s profits. With these anticipated funds, the Foundation will have resources to fund the development and availability of therapeutics in areas in which philanthropic funding is needed to expand patient treatment options.

Executive Committee

CHAIRMAN: Alexis Cazé

PRESIDENT: Andrew ElBardissi, MD

VICE PRESIDENTS

TREASURER: Kerri Seacord

SECRETARY: Kathryn Wilson 

Academic Collaborations

Deerfield Management recognizes that investigators at academic research institutions provide much of the novel insights that advance our understanding of disease. However, at any research institution, the most commercially promising innovations eventually outgrow the lab, requiring greater resources and more focused development expertise than an academic setting can typically provide.

To bridge that gap, Deerfield partners with leading academic research centers from across the country, providing critical funding and expertise to further sustain and accelerate the commercialization of discoveries toward meaningful societal impact by advancing cures for disease.

Together with its academic partners, Deerfield has created 16 spin-off companies to date that are supporting key avenues from concept to spin-out of novel therapeutic discoveries, as well as an incubator focused on innovative cardiovascular devices.

Deerfield’s 16 academic partnerships, involving 18 institutions, include Boston Children’s Hospital, University of Michigan, Yeda Research and Development Co. Ltd., the commercial arm of the Weizmann Institute of Science; Duke University; Columbia University; Northwestern; Harvard; Vanderbilt; Johns Hopkins; Dana Farber; the Broad Institute; University of North Carolina-Chapel Hill; University of California-San Diego; and the University of Illinois at Chicago. Deerfield also has a combined association with Rockefeller University, Cornell, and Memorial Sloan Kettering Cancer Center through their joint discovery unit, the TDI. Finally, Deerfield has a project-specific collaboration with MD Anderson Cancer Center.

Far beyond its financial resources—with its long vision, operational expertise, and command in the life science and healthcare space for more than two decades, Deerfield is uniquely positioned to support all stages of development from early-stage to market—advancing science and enabling the translation of ideas into medicines.

Break into the Boardroom

Despite the high aptitude of this representative sample of female leaders, the stark reality is boards are only made up of 20% women. Deerfield and Oxeon founded the Break into the Boardroom program (BiB) based on a shared belief that their organizations are uniquely positioned to not only cultivate new female board candidates but to also connect these women with concrete governance opportunities.

Deerfield and Oxeon focus on identifying talent, building companies, and deploying capital within the healthcare ecosystem, which enables BiB to create the perfect intersection of supply and demand. This framework naturally mitigates the classic chicken and egg problem that has proven such an intractable obstacle to the goal of increasing female board representation.

Please visit our website where you may submit inquiries regarding potential board roles or nominate a female executive from your organization to participate in our program.

Funding models

Deerfield tailors flexible financing options designed to meet the needs of its corporate partners most optimally. Some of our funding options include:

CURE.

At CURE. — Deerfield’s innovation campus on 345 Park Avenue South — we’re transforming healthcare. Here, innovators from across the industry and around the world work shoulder to shoulder to develop treatments to eliminate deadly diseases and create new healthcare delivery models to lower cost and improve care for those in need.

For CURE. inquiries, please email us

Legal Analytics for Counsel Selection

When a company enters litigation, it must select litigation counsel. The management of the company would usually call its peers and ask about past experiences, review counsels’ fields of technical expertise, evaluate their success rates, and then invite a handful of law firms to make a pitch. The invited attorneys would propose a case strategy and predict their probability of success. The management would then select a counsel based on the presentations given and their personal impressions.

Ex Parte is a start-up formed about two years ago that is trying to change appellate counsel selection for patent cases.[1] The company collects data for every appellate case since 2004 and combines it with a database of all practicing lawyers. It then uses a proprietary algorithm to identify a lawyer with the highest probability of success for a specific case. When Ex Parte analyzed the recent appeal by 10X Genomics, the company predicted that an average lawyer would have a nine percent probability of winning the case but hiring one particular litigator would increase the probability of success to 25 percent.

The attorney recommended to 10X Genomics by Ex Parte expressed concerns over the ethical implications of this analysis. For one, the lawyer no longer did patent appeals. Also, according to the American Bar Association’s model rules for professional responsibility, lawyers should not create an “unjustified expectation” of a future result based on their part performance.[2] But this is what Ex Parte may be doing – creating expectations of future performance based on past statistics.

In the U.S., the work of Ex Parte is protected by First Amendment rights and companies are not restricted in using its predictions to choose a litigation counsel. However, if a lawyer were to project his own probability of success based on his past record, that would be considered unethical. France has a law completely banning software companies from providing legal and judicial analytics.[3]

Additional concerns revolve over the ability of the software to account for specific facts of the case and the quality of data available from law firm websites. In the case with 10X Genomics, Ex Parte recommended a lawyer who no longer practiced patent appeals because the law firm website had not been updated with his current status. Ex Parte’s information may also interfere with the client’s relationship with counsel, where the software analysis of the probability of success in a case contradicts the counsel’s.

Also, “the law of small numbers” cautions that percentages may appear greatly superior or inferior based on small data sets – the appellate practice is so small that most lawyers only get a few cases in their lifetime. In the example of 10X Genomics, the counsel recommended by Ex Parte had litigated 34 cases, of which 20 were identified as patent appeal cases. The Court of Appeals for the Federal Circuit, which is the sole appellate court for patent appeals, has heard more than 4,000 patent cases since 2004.

With computers infiltrating almost every aspect of our lives, the use of computer-assisted legal analytics is only expected to increase with time. With new technology comes the need to evaluate new ethical considerations. On one hand, making predictions about future success based on past legal achievements may be considered borderline unethical by the legal community. On the other hand, it can be argued that a company such as Ex Parte merely provides additional information and another viewpoint for clients with which to make informed decisions. Litigations are sometimes driven by unfounded beliefs in the strengths of a company’s position, and data from Ex Parte may inject rationality into corporate decision-making and facilitate settlements.

In addition to companies that are entering litigation, Ex Parte’s services are also retained by law firms seeking better marketing positions and financial firms that fund litigation. With litigation being a $100 billion a year industry, any attempt to help quantify outcomes is an understandable goal. The question is whether and where the lines should be drawn for an ethical balancing act.

[1] Roy Strom, “The algorithm will hire your patent lawyer now,” Bloomberg Law, 8/1/2019.

[2] ABA’s Model Rules of Professional Conduct, Rule 7.1.

[3] Sam Skolnik, “France’s judicial analytics ban unlikely to catch on in the U.S.,” Bloomberg Law, 6/5/2019.

Does Artificial Intelligence Dream Of Collecting Royalties?

English mathematician Alan Turing introduced the concept of a thinking computer in a paper in 1950, and American computer scientist John McCarthy coined the term “artificial intelligence” (or AI) during the Dartmouth Conference in 1956[1]. For a while, the idea of thinking machines was confined to the realms of science fiction, but recent gains in computational power and data access have made AI the most disruptive technology of the 21 century. The influence of AI has permeated numerous historically human activities, including farming, manufacturing, commerce, transport, medical care, rescue, and education[2]. AI is capable of analyzing ever-growing volumes of data in ever-shortening times, and has also become capable of generating creative ideas. The Creativity Machine, developed by Stephen Thaler in 1994, was the first known machine that generated an invention resulting in the US Patent No. 5,852,815[3]. The Invention Machine created by John Koza in 1995 created an invention described in US Patent No. 6,847,851. Thaler and Koza named themselves the inventors and did not disclose the involvement of AI to the Patent Office.

The American patent law system was praised by Abraham Lincoln as one of the three great advances in world history[4].However, the system is facing significant conceptual challenges with the advancement of artificial intelligence. Under current legal system, patents are granted to inventors who contributed to the conception of the invention. Conception is defined as a “formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention,” a clearly human-centric concept[5]. The Federal Circuit has repeatedly ruled that to be deemed to “perform this mental act, inventors must be natural persons and cannot be corporations or sovereigns”[6].

So, who is the inventor when the creative idea is produced by artificial intelligence? Under the current legal framework, it is not the programmer because (s)he did not conceive the creative idea produced by the computer and may not even know the problem posed to the computer by the user. It is not the user, who also did not personally come up with a solution. Accordingly, under the current legal framework there can be no patent for an invention generated by AI because no “natural persons” conceived the invention.

In some fields, expensive developments do not happen without patent protection. The prospects of obtaining lucrative license agreements or a competitive advantage provide strong economic incentives to innovate and to patent inventions. The goal of the patent system is to provide these economic incentives, and there is ample evidence that the U.S. patent system has been working as intended. The rise of AI will force us to reevaluate our definitions and criteria for patentability in the near future.

Despite the uncertain future of patentability of AI-generated inventions, many firms are invested heavily in the development of AI systems. As of March 3, 2019, there were at least 127 start-up companies focused on application of AI in drug discovery[7]. Sanofi signed a $300 million dollar deal with Exscientia. The VC firm Andreessen Horowitz launched a $450 million dollar fund focused on applications of AI in drug discovery. Recognizing the insufficiency of the current legal system in addressing AI, the United States Patent and Trademark Office held a meeting on “Artificial Intelligence: Intellectual Property Policy Considerations” on January 31, 2019. Possible considerations include changing the law to allow listing AI as the inventor or listing no inventors on the face of the patent, or changes to the law of obviousness. While no solutions were developed at the meeting, the growing recognition of the issue is the first step to developing new laws to meet the challenges created by advances in technology.


[1]   Exec. Office of the President Nat’l Sci. and Tech. Council Comm. on Tech., Preparing for the Future of Artificial Intelligence (2016.)

[2]   European Parliament resolution of 16 February 2017

[3]   Ryan Abbott, “I Think, Therefore I Invent: Creative Computers and the Future of Patent Law”, B.C.L. Rev. 57(4), 1079 (2016)

[4]   Abraham Lincoln, “Second Lecture on Discoveries and Inventions” at the Phi Alpha Society of Illinois College at Jacksonville (February 11, 1859), https://www.thenewatlantis.com/publications/second-lecture-on-discoveries-and-inventions

[5]   Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (1986).

[6]   University of Utah v. Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften EV, 734 F.3d 1315, 1323 (Fed. Cir. 2013); see also Beech Aircraft Corp. V. Edo Crop., 990 F.2d 1237, 1248 (Fed. Cir. 1993) (“[O]nly natural persons can be ‘inventors.’”); New Idea Farm. Equip. Corp. v. Sperry Corp., 916 F.2d 1561, 1566 n.4 (Fed. Cir. 1990) (“people conceive, not companies”).

[7]   https://blog.benchsci.com/startups-using-artificial-intelligence-in-drug-discovery

What Makes A Good Patent?

Patents are filed for various strategic reasons and sometimes observers have difficulty discerning patent quality. What makes a good patent? There is no universal answer or formula. Reasonable people can look at the same patent and disagree on whether the patent is good or not. However, in the case of therapeutic patents, experimental data is vital to patent quality.

Unlike other types of patents, patents on therapeutics should have some experimental data in order to withstand challenges. In one case, Dr. Bonnie Davis invented a treatment for Alzheimer’s disease solely while reviewing the literature. The literature described that galanthamine had anticholinesterase properties. The literature also described an increase in short-term memory in dogs after administering galanthamine and a correlation between Alzheimer’s disease symptoms and a reduced level of acetylcholine in the brain. Dr. Davis deduced that galanthamine can be used to treat Alzheimer’s patients, and she was correct. She filed for a patent using prophetic examples, and the patent was granted on May 5, 1987. The experimental proof of her theory was completed two months later in July of 1987. In 1995, Dr. Davis licensed the invention to Janssen. Generic pharmaceutical companies seeking to market generic versions of Janssen’s drug successfully challenged the validity of this patent. The Federal Circuit affirmed the invalidity determination by the district court because relevant animal testing experiments were “not finished…by the time the ‘318 patent was allowed”. Judge Dyk wrote that “[t]ypically, patent applications claiming new methods of treatment are supported by test results,” and “under appropriate circumstances, . . . the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question.” This case highlights the crucial importance of data to the validity of therapeutic patents. In re ‘318 Patent Infringement Litigation (Fed. Cir. 2009).  

The next consideration is how much data should be included in the patent application. Generally, broader coverage requires more data. In any case, more data is better, but this creates a dilemma. On one hand, the U.S. has a “first inventor to file system” – the first to file gets the patent. Wait too long to accumulate data and somebody else may get the patent first. File before you have sufficient data and the application may get rejected, or a weak patent may get issued that cannot withstand subsequent challenges. The latter comes with the wasted costs of the developing a therapeutic product only to see the benefits go to generics. A fact finder may find that there was insufficient proof that the invention would work for the intended purpose. For Star Trek fans, a patent application may describe a tricorder, but without more – it is still only science fiction. Even when credible, the details must be thorough enough to allow others to copy the invention after the patent expires. Finally, when very little data appears sufficient, a fact finder may view the invention as obvious. The decision on the quantity and quality of data needed is a balancing act usually decided with the help of counsel who is up-to-date on industry standards.

A patent applicant is required to submit enough data to show the inventor is in possession of the invention, the invention will work for the intended purpose, and that others will be able to practice the invention without undue experimentation. The level of data required in the patent application depends on the nature of the invention, but all therapeutic patents should have some data. A patent attorney helps to determine the sufficiency of the data by reviewing court cases where similar patents were upheld or invalidated. In many cases, it is still an educated guess. However, based on the current interpretation of the law, it is prudent to err on the side of having more data, especially in the case of therapeutic patents.

Patent Musings In Numbers And Figures

In 2017, 352,585 new patents were granted and 374,731 patent applications were published by the US Patent and Trademark Office. The publication number represents a roughly 5% decline from the previous year. One trade publication comments that one reason for the decline is “patent owners are getting smarter and doing a better job of filing patent applications that are more useful.[1]” Regardless of the decline, there are still on average over 1,000 new patent applications published daily. Patent owners and inventors continue to see high value in obtaining patent exclusivity and are willing to pay the costs. Despite all the criticism of the US patent system and all the uncertainty, patent owners continue to trust that the system is reasonable and useful.

While the pro-patent mentality has a long history in the U.S., originating in the U.S. Constitution, it is also interesting to look at IP activity from other parts of the world. US patentees continued to dominate patent grants at the US Patent Office with 179,522 patents last year (patent owners from the rest of the world received 173,063 patent grants). South Korea came in second with 23,525 patents followed by Germany (17,545), China (13,120) and a tie between Japan and Taiwan (12,622 each). European countries, such as the UK, France, an Italy produced significantly fewer patents. The worldwide patenting activity, however, is different. According to the World Intellectual Property Organization Report for 2016[2], that year Asia produced just over 2 million patent applications or 64.6% of all patent applications filed world-wide, three times more than North America.

The same report shows China emerging as one of the lead innovators, with over 1.2 million patent applications filed at its home office in 2016, predominantly from residents of China, followed by ~600,000 applications filed in the US, split roughly evenly between residents and non-residents. Rounding out the top 3 is Japan, which also had roughly 300,000 domestic applications, and a smaller proportion of applications from non-residents.

Looking more closely at China’s patent office, Chinese entities filed four times more patents in China than U.S. entities did in the U.S. However, numbers alone may be misleading, as some commentators suggest that Chinese companies are required to file a certain number of patents and the pressure from this requirement produces low quality patent filings. On the other hand, the increased patent activity from China and other countries in Asia may indicate a drastic change in the IP enforcement attitudes from anti- to pro-patent. The numbers may reflect a genuine boom of the Chinese IP economy.

In the U.S., two areas remain as pillars in the U.S. intellectual property system – innovative activity at academic institutions, and IP enforcement by the U.S. Federal courts. In 2016, 9 of the top 10 most innovative universities by the number of issued patents are in the U.S, led by the University of California system, MIT, and Stanford. The lone OUS academic institution to crack the top 10 is Tsinghua University[3].

In 2017, 4,072 new patent cases were filed in district courts, down from a peak of 5,874 in 2015, but up from the low of 2,582 in 2005. Last year patent cases also saw renewed interest by the US Supreme Court. The highest court reviewed and clarified several memorable issues. In Life Technologies. Corp. v Promega Corp., infringement by a single component of a multi-component system assembled abroad was reviewed. The topic of laches, or unreasonable delay in bringing a suit was revisited in SCA Hygiene Products v First Quality Baby Products, LLC. Patent exhaustion (Impression Products Inc. v Lexmark International Inc.) and proper litigation venue (TC Heartland LLC v Kraft Food Group Brands LLC) were also revisited. Even the constitutionality of IPR proceedings was taken up by the Supreme Court in Oil States v Greene’s Energy Group for review.

The rate of innovation in the U.S. appears robust and healthy and there is hope that the renewed interest from the Supreme Court will inject even greater predictability into U.S. patent litigation.

[1] https://www.anaqua.com/learn/anaqua-perspectives/2017-patent-analysis-patentees-are-making-more-informed-filing-renewal

[2] http://www.wipo.int/edocs/pubdocs/en/wipo_pub_941_2017-chapter2.pdf

[3] National Academy of Inventors, “Top 100 Worldwide Universities Granted U.S. Utility Patents” 2016