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biolink Legal Column - November 2014

Wednesday, November 26, 2014   (0 Comments)
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Do Not End Up With An Unenforceable Patent – It’s Your Hard-Earned Patent

Vara Prasad V.N. Josyula, Ph.D., Honigman Miller Schwartz and Cohn LLP


 Vara Prasad, V.N. Josyula, Ph.D.

In general, many people are aware of the value of patenting an idea or invention, filing a patent application, and getting it granted. Moreover, most applicants are aware of the costs associated with the patent prosecution process and payment of maintenance fees throughout the patent’s life cycle. However, many people, even many inventors, are not aware that a patent can be unenforceable due to violation of duty of disclosure and/or inequitable conduct. It is possible (vide infra) that one could end up with an unenforceable patent by not following the simple rules and laws related to the intellectual property.1,2   


The inventor and every other individual who is substantially involved in the preparation or prosecution of the application and who is associated with the inventor or the inventor’s assignee have a duty to disclose all the information material to patentability in good faith and candor to the United States Patent and Trademark Office (USPTO).3 These duties, somewhat unique to U.S. Patent laws and rules, are codified in 37 CFR 1.56. These duties are intended to provide the USPTO with the information of the types it needs to make a proper and independent decision on patentability.


Typically, the information material to patentability is submitted through an Information Disclosure Statement (IDS) and may contain patents, published patent publications, journal articles, technical brochures, and any other relevant documents, both U.S. and foreign. The types of potentially material information that should be disclosed to the USPTO include, among others, the prior art cited in related foreign applications, including prior art cited in the International Search Report (ISR) or the European Search Report or any other searches done by foreign agencies; information relating to or from co-pending United States patent applications; existence of any litigation and any other material information arising therefrom; and information relating to claims copied from a patent. As more information becomes available during the prosecution of the patent application, one can file several IDSs, and this duty to disclose information exists until the application becomes abandoned or until a patent is granted on that application.


Violation of the duty of disclosure may lead to inequitable conduct and unenforceability of the patent. Inequitable conduct is not set by statute as criteria for patentability but rather is an application of the equitable doctrine of “unclean hands” by the federal courts.3 Two important Court of Appeals for the Federal Circuit (CAFC) decisions, namely Therasense v. Becton Dickinson (in 2011)4 and 1st Media v. Electronic Arts (in 2012)5, shed light and guidance on inequitable conduct. Two criteria are particularly noteworthy: (i) evidence of “but-for materiality,” that is, the USPTO would not have allowed the claim over the undisclosed (or misrepresented) information, and (ii) evidence of alleged intent to deceive the USPTO by withholding disclosure. However, the knowledge of materiality and the failure to disclose a reference are insufficient by themselves to demonstrate inequitable conduct. The evidence must also show, directly or inferentially, that the patentee made a deliberate decision to withhold a reference that is material to patentability from the USPTO.


On August 15, 2014, in Apotex v. UCB6 ,and on September 26, 2014, in American Calcar v. American Honda Motor Co.7, the CAFC found that Apotex’s (USPN 6,767,556 ) and American Calcar’s (USPNs. 6,330,497; 6,438,465 and 6,542,795) patents are unenforceable due to inequitable conduct. Though significant differences exist between these two cases, CAFC affirmed the previous district court’s opinion that material relevant to the patents was not provided by the applicants to the USPTO; in Apotex’s case, the CEO-inventor of the patent failed to disclose, and in Calcar’s case, the founder- inventor failed to disclose.  


It takes a significant investment of intellect, time, and money to obtain a patent. It is very important to note that all the claims in the patent would be unenforceable, even though the court might find inequitable conduct connected to only one particular claim. An incentive remains to submit the information to USPTO because it will result in a strengthened patent and will avoid later questions of materiality and intent to deceive3.  Because patents are bread and butter to many companies for survival, one should be careful to disclose all pertinent information to the USPTO to make certain that the patent is enforceable.


Vara Prasad, V.N. Josyula, Ph.D., is a patent agent with Honigman Miller Schwartz and Cohn LLP. He holds a Ph.D. in Chemistry and has several years of research experience. Vara Prasad can be reached at (734) 418-4212 or



1. Mack, K. Berkeley Technology Law Journal, 2006, 21(1), 147-175.

2. Erstling, J. Creighton Law review 2011, 329-366.

3. Manual of Patent Examination Procedure, Chapter 2000.

4. Therasense v. Becton Dickinson, No. 2008-1511 to 1514 and 1595 (Fed. Cir. May 25, 2011).

5. 1st Media v. Electronic Arts, No. 2010-1435 (Fed. Cir. Sept. 13, 2012).

6. Apotex v. UCB, No. 2013-1674 (Fed. Cir. Aug. 15, 2014).

7. American Calcar v. American Honda Motor Co., No. 2013-1061 (Fed. Cir. Sept. 26, 2014).




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