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SEC Filings

DEFM14A
ASTERIAS BIOTHERAPEUTICS, INC. filed this Form DEFM14A on 02/04/2019
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Protecting Asterias’ Intellectual Property

 

Asterias seeks to protect its intellectual property by, among other methods, filing United States and foreign patent applications related to Asterias’ patentable intellectual property that Asterias considers important to the development and implementation of Asterias’ business and strategy. In addition to relying on patents, Asterias relies on trade secrets, know-how, and contractual agreements to protect Asterias’ intellectual property.

 

Asterias’ success depends, in part, upon Asterias’ ability to obtain and maintain patent and other intellectual property protection for Asterias’ product candidates including compositions-of-matter, dosages, and formulations, manufacturing methods, and novel applications, uses and technological innovations related to Asterias’ product candidates and core technologies. Asterias’ business would be negatively impacted if Asterias is not successful in developing additional proprietary technologies that are protected either as trade secrets or by filing additional patent applications.

 

Asterias cannot ensure that patents will be granted with respect to any of Asterias’ pending patent applications or with respect to any patent applications that may be filed by Asterias in the future, nor can Asterias ensure that any of Asterias’ existing or subsequently granted patents will be useful in protecting Asterias’ drug candidates, technological innovations, and processes. The claims of any patents that are issued may not provide meaningful protection, may not provide a basis for commercially viable products or may not provide Asterias with any competitive advantages. Because of the extensive time required for clinical development and regulatory review of a product candidate, certain patents related to Asterias’ product candidates will expire before any of Asterias’ product candidates can be commercialized, while other patents may remain in force for only a short period of time following commercialization, thereby reducing the advantage afforded by any such patent. In addition, others may independently develop similar or alternative technologies, duplicate any of Asterias’ technologies and, if patents are licensed or issued to us, design around the patented technologies licensed to or developed by us. Therefore, Asterias’ competitors may be able to commercialize similar products, or may be able to duplicate Asterias’ business strategy, without infringing Asterias’ patents or otherwise using Asterias’ intellectual property.

 

The protection afforded by any particular patent depends upon many factors, including the type of patent, scope of coverage encompassed by the granted claims, availability of extensions of patent term and legal interpretation of patent laws in the United States and other countries that could diminish Asterias’ ability to protect Asterias’ inventions and to enforce Asterias’ intellectual property rights. Furthermore, others may have patents that relate to Asterias’ technology or business that may prevent Asterias from marketing Asterias’ product candidates unless Asterias is able to obtain a license to those patents. Accordingly, while Asterias’ ability to maintain and solidify Asterias’ proprietary position for Asterias’ products and core technologies will depend, in part, on Asterias’ success in obtaining and enforcing valid patent claims, Asterias cannot predict with certainty the enforceability of any granted patent claims or of any claims that may be granted from Asterias’ patent applications.

 

The biotechnology and pharmaceutical industries are characterized by extensive litigation and other challenges regarding patents and other intellectual property rights that involve complex legal and factual questions making Asterias’ patent position generally uncertain. Any existing or subsequently granted patents may be challenged, invalidated, found unenforceable, circumvented or infringed. Asterias has been involved in the past in administrative proceedings with respect to Asterias’ patents and patent applications and may, as a result of Asterias’ extensive portfolio, be involved in such proceedings in the future. Additionally, in the future, Asterias may claim that a third-party infringes Asterias’ intellectual property or a third party may claim that Asterias infringes its intellectual property. In any of the administrative proceedings or in litigation, Asterias may incur significant expenses, damages, attorneys’ fees, costs of proceedings and experts’ fees, and management and employees may be required to spend significant time in connection with these actions.

 

A patent interference proceeding may be instituted with the United States Patent and Trademark Office (“USPTO”) when more than one person files a patent application covering the same technology, or if someone wishes to challenge the validity of an issued patent on patents and applications filed before March 16, 2013. At the completion of the interference proceeding, the USPTO will determine which competing applicant is entitled to the patent, or whether an issued patent is valid. Patent interference proceedings are complex, highly contested legal proceedings, and the USPTO’s decision is subject to appeal. This means that if an interference proceeding arises with respect to any of Asterias’ patent applications, Asterias may experience significant expenses and delay in obtaining a patent, and if the outcome of the proceeding is unfavorable to us, the patent could be issued to a competitor rather than to us. For patents and applications filed after March 16, 2013 a derivation proceeding may be initiated where the USPTO may determine if one patent was derived from the work of an inventor on another patent. Inventorship may also be challenged in litigation.

 

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