Moving in the Right Direction: Cocrystals and the FDA

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Using Solid Form Patents to Protect Pharmaceutical Products — Part I

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Using Solid Form Patents to Protect Pharmaceutical Products — Part II

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Continuing Legal Education Course- 1.0 Hr Credit
Vaccine Emergency Use Authorization, Approval, and Liability - Exploring the Science and Law Behind Vaccines for SARS-COV-2
February 4th, 2021
12:00-1:30PM ET
This seminar will be divided into two primary portions.  In part I, Professor David Sanders, of Purdue University, will discuss scientific aspects of the vaccines and SARS-COV-2 and explain how the various vaccine technologies are designed to defend againstSARS-COV-2 infection.  In Part II, Eyal H. Barash, a patent attorney who has an extensive pharmaceutical practice, will discuss the regulatory framework behind the Emergency Use Authorization and how it differs from the approval of a pharmaceutical product.  In addition, the talk will also discuss the Countermeasure Injury Compensation Program, the federal framework for covering injuries due to health countermeasures taken in public health emergencies and how it relates to COVID vaccines. This event is a fundraiser for the Jewish Federation of Lafayette, and donations would be greatly appreciated.
AAPS eChalk Talk:
Emergency Use Authorizations of Coronavirus Vaccines – Similarities and Differences between and EUA and Approval and Legal Ramifications of potential Vaccine Injury
Emergency Use Authorizations as we know them now were borne out of the terror attacks on 9/11 and subsequent anthrax mail incidents and came into law in 2004 and have been amended in 2013 and again in 2016.  As of 1/1/2021, two vaccines have been authorized for use in the United States, each under an EUA.  This talk will explore the history of the EUA, the changes made to the EUA, and how it is being utilized today.  The talk will also discuss the differences between EUAs and Approvals as well as the federal government’s absorption of damages from vaccine injuries – who and what is covered and what are the limitations.


What is a solid form?

A solid form is the solid representation of a chemical compound.  Examples include polymorphs, salts, solvates, hydrates, cocrystals, and amorphous solids.

Why patent solid forms?

Solid forms are compositions of matter and Orange-Book listable as drug substance.  When the science is right, patenting follows.

How do you patent a solid form?

The same rules apply to solid forms as to any other inventions.  Careful attention should be paid to the kinds and quality of data used in solid form patents.


pharmaceutical patents

Orange-Book Listable Patents Add Value


Intellectual Property as Deal Currency

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A Strategy Requires a Realistic Plan


Legal Functionality as a Business Driver