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Inspirations for BioPharma IP Strategy

May 22, 2012
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Reid Adler

on 10 January 2013

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Transcript of Inspirations for BioPharma IP Strategy

IP Licensing Inspirations for Biopharma IP Strategy Presentation to the Chicago Chapter, Licensing Executives Society on May 22, 2012

by Reid Adler, attorney & consultant
(and member of the Maryland Chapter, LES) Some Questions and Examples to Consider What is IP strategy?
How does IP strategy connect to IP licensing?
Big-picture biopharma trends
Notable examples of IP strategies
Where to find IP strategies:
disruptive changes in technology
changes in law/regulations
compelling new business models
Other sources of strategy inspiration?
How to take the lead in developing IP strategies! Understand business opportunities

Choose the direction, vision and goals of an enterprise (or program)

Select a path to reach these goals

Develop a plan to connect operational activities to organizational goals

Consider business as a chess game (or war) Strategic Thinking Is a subset of corporate strategy and a product of strategic thinking!

The objective of IP strategy is to develop an exclusivity portfolio that will:
extend a product's life cycle (days matter)
capture market share
provide flexibility in changing/improving product
cover what’s on the FDA-approved label to deter or delay generics
discourage competition in general
provide a tool to enforce exclusivity rights So What Is IP Strategy? IP Strategy: And operationally? By Ralph Eckardt, 3LP Advisors. In a briefing note for Int’l IP Strategists Ass’n Valuation of the IP component
Control (or influence) over IP asset management
Exit strategies and contingencies for the deal
How and when to settle ANDA disputes, a popular alternative to litigating to a final judgment
Early design of clinical trial strategy to generate IP that corresponds to the product label
Management of "Brand Plan" and "Shark Fin Team" to address lengthened exclusivity potential Nexus Between IP Strategy and Licensing Practice External vs. internal R&D shifts
Reimbursement is critical to product success
Product differentiation increases probability of success
Companion diagnostics may qualify a product for approval and also reimbursement
One more day of exclusivity can be immensely valuable
What’s on the label can be protected by IP to exclude competitors
Patient compliance is a growing challenge
Potential impact of iPhone and Android apps?
Is there a once-a-day technology delivery platform to create or dominate? Biopharma “Mega” Trends and Realities You can extend a product's market share quite dramatically by undertaking a carefully planned multidisciplinary strategic plan. In 1995, AstraZeneca established its Shark Fin Project Team which developed and marketed Nexium. This preserved a multi-billion dollar product market! Sanofi filed a Citizen Petition with FDA in Feb 2003 seeking to delay approval of enoxaparin until the generics had been fully characterized or their manufacturing process was shown to be the equivalent of Sanofi’s process or the product passed clinical testing
The “innovator” Sanofi lost its patents on Lovenox (a low molecular weight, enzymatically digested heparin anticoagulant)
FDA’s approval of the ANDAs took several years because the product’s structure included complicated sugar molecules not naturally found in heparin, and raised concerns about immunogenicity
Ultimately, Momenta Pharmaceuticals (an ANDA approved generic) enjoined two other generic companies in 2011 from marketing enoxaparin The Lovenox Story “A method for analyzing an enoxaparin sample for the presence or amount of a nonnaturally occurring sugar…” that was characteristic of enoxaparin

In January, the US Court of Appeals for the Federal Circuit stayed an injunction against otherwise infringing competitors pending an appeal.

The Court's had been asked to invoke the "safe harbor" provision of the patent law (Section 217(e)(1) If the strategy works for Lovenox, it should also protect biologics and "biobetters" Patient Protection and Affordable Care Act (2010) created abbreviated approval pathway for biosimilars that are interchangeable with FDA-licensed biological products, analogous to generic medicine

"Reference" products have 12 years of market exclusivity, independent of patents

FDA draft guidelines issued in Feb 2012, comment period recently ended Biosimilars may be the "new" generics If a clinical trial is needed, why not make a biobetter when the incremental cost is relatively small?

When is a a mixture of proteins the "same" and how would the patent enablement requirement be satisfied? What about post-translational modifications?

What choice of IP will best protect a biological product -- patents or trade secrets?

Selection and protection of manufacturing QC steps or assays for identification of active moieties may be determinative of market success

Remedies for the innovator are changed, too Or maybe not? Momenta’s patent on Lovenox claimed: Who makes fundamental decisions about product differentiation, marketing strategies, innovator vs. generic, biosimilar vs. biobetter
Rethink allocations of risk?
Consultation with regulatory agencies? National differences in guidelines?
Some of the players have changed, e.g, Fujifilm and Samsung and others may join the market
Other players have switched sides, e.g., generics now develop proprietary products and big pharma competes for biosimilars
IP and technology alliances may become important (Open Source technologies?) Other thoughts about IP Strategy and IP Licensing Provisions to Negotiate IP-related court decisions in the US and major markets
Avoid other companies' business and litigation mistakes
www.clinicaltrials.gov
www.patentdocs.com
Strategic Management Society (Chicago)
Int'l IP Strategists Association (www.intipsa.com is a new, UK-based professional society)
IP strategy consultants, blogs and the like
Conference symposia such as CHI, ACI, etc Other Sources of Inspiration for
IP Strategizing with the "Team" 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. The Prometheus Patent Claim Don't overestimate the Supreme Court's understanding of patent law, or the speed of FDA's implementation of biosimilar rules What's different for biosimilars? 1. A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising:
(a)  providing patient information to a computing device comprising:a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition;a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition;a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and
(b)  generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient; and
(c)  generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules.  Spawn of Prometheus SmartGene vs Advanced Biological Labs (March 2012) The most expansive changes to US patent law since 1952
US now joins the world with first-to-file
Creates simplified and more useful procedures to challenge the validity and scope of granted patents
Yet the substantive requirements for patentability are the same
Together with the new biosimilars law and regulations, legal challenges involving biosimilar products will follow a different and as yet uncertain litigation path America Invents Act of 2011 Implications for companion diagnostic strategies? And business complications? Myriad A method for predicting the response of a patient to a drug comprising:
obtaining a biological sample from a patient;
measuring the level of dysfunction or disequilibrium in the sample as compared with a control sample; and
advising the subject or his/her medical advisor that the patient will not respond to the current first line drug when the level of dysfunction is elevated in the first sample relative to the control sample A better patent claim strategy? Or pursue Lovenox claims, too? It's hard to know where the Supreme Court's concerns about "mental correlations" and "products of nature" will end! .... surveying the road ahead with an interdisciplinary team is critical, including marketing, legal, business development and IP. Given the complexities of legislation, regulation, litigation, technology and biology ... Vacated and remanded to the Federal Circuit to reconsider the patentability of DNA sequences in view of the Supreme Court's Mayo decision www.RAdlerLaw.com and www.practicalipstrategy.com
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