VIVUS Qsymia Patents: Vivus and Its Lawyers Acknowledge the Materiality of Weaknesses in the Qsymia Patent Position

by bobbydiggs

* Vivus considers the contents of the vivuspatent blog sufficiently material to disclose to the United State Patent and Trademark Office (USPTO)

* Vivus also discloses the McElroy provisional patent application, which describes the combination of phentermine with topiramate for the treatment of obesity and predates the earliest Qsymia patents

* Vivus fails to disclose the details of Dr. Najarian’s medical practice where he “treated thousands of patients” with combinations of phentermine and topiramate from 2001-2010.

View the press release.

First of all, I would like to welcome Examiner Ahmed from the USPTO to the vivuspatent blog.  I also look forward to Examiner Maier’s anticipated visit in the future.

There has been an interesting development in the prosecution of two Vivus patent applications with pending claims directed to Vivus’ anti-obesity drug Qsymia (phentermine and topiramate XR). On September 16th, Vivus’ patent counsel Mintz Levin filed a set of patent prosecution documents1 for US Application Nos. 12/481,540 (the ‘540 application) and 12/481,548 (the ‘548 application) that included, among other things, two identical information disclosure statements (IDS) that list each of the posts found in this blog. The IDS’s2 also list the McElroy provisional patent application (60/121,339) – the materiality of which is discussed throughout this blog and in a recently filed third party observation in Europe.

The IDS’s as filed can be viewed here.

As defined in 37 CFR 1.56, “Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability.” This material information is most often disclosed in the form of an information disclosure statement (IDS) that is reviewed by the corresponding patent examiner and becomes a part of the official patent record (i.e., the file wrapper).  For a more thorough discussion about who has a duty of disclosure, candor and good faith to the USPTO and what kinds of information need to be disclosed, please see the August 12th vivuspatent blog post, “VIVUS Qsymia Patents: Appearance of Ongoing and Systematic Inequitable Conduct before the USPTO by Vivus and its Attorneys”.

What Does the New IDS Mean for Vivus?

The decision to file an IDS including the entirety of the vivuspatent blog leads to some interesting conclusions while also leaving some unanswered questions:

* Most importantly, Vivus and its patent counsel deem the contents of the blog to be material to the patentability of the pending Qsymia patents. Further, the patent examiner for the ‘540 and ‘548 applications (Hasan Syed Ahmed) will now consider the contents of the blog when determining the patentability of the pending Vivus applications.

* When did Mintz Levin know about the information put forward in the blog, and when did it decide to include the blog in an IDS? Did it require the August 12, 2013 blog post that included a linked email to spur action? Here is an excerpt from that post:

In the meantime, a link to the vivuspatent.wordpress.com blog has been emailed to the three Mintz Levin attorneys listed in the prosecution documents of Vivus’ Qsymia patents as well as three members of firm management. The email explains that the linked blog contains information that may be material to the prosecution of Vivus’ Qsymia patents and they may feel a need to disclose some or all of it to the USPTO.

* The above question also applies to the other parties that share the same duty of candor and good faith when dealing with the USPTO, namely Vivus employees substantially involved in the preparation or prosecution of the Qsymia applications, Vivus’ former outside patent counsel as well as the named inventors (Thomas Najarian, Peter Tam and Leland Wilson).  Did any of these individuals fail to meet their duty of candor and good faith? Did it finally take a member of Mintz Levin’s management to recognize that its own firm’s reputation and liability could potentially be at stake should they fail to act?

* Does disclosing the blog in an IDS satisfy Vivus and Mintz Levin’s duty of candor obligation under 37 CFR 1.56? For example, does the USPTO now have enough information about the below alleged instances of misconduct, misstatements and omissions to properly determine if or how they are material to the patentability of the Qsymia patents?

a. Failure to notify the USPTO of its position that earlier issued Najarian patents are not enabled throughout the scope of the currently issued claims;

b. Conflicting characterization of Qsymia’s side effect profile before the USPTO versus the FDA;

c. Failure to correct the record regarding the earlier mischaracterization of the lack of prior art from 1996-1999 when the parties were almost certainly aware of the McElroy patent; and

d. Failure to disclose the details of Dr. Najarian’s 2001-2008 prescribing history of combination treatments of phentermine and topiramate at his Los Osos, California weight loss clinic as potential prior public use.

It should be noted that for all patents filed after 2001, the failure to disclose the details of Dr. Najarian’s 2001-2008 prescribing history may well be the most important prior art because a named inventor, Dr. Najarian, was practicing the alleged invention for years, which according to a colleague’s statement in the New York Times included treating “thousands of patients” and presumably the outcomes from said treatments. Neither Dr. Najarian, Vivus nor its patent counsel have ever provided a summary, let alone a detailed account, of this extensive prior use. How is this consistent with the duty of candor?

Next Steps

With the USPTO now notified of the weaknesses inherent in the Qsymia patent portfolio, there are two jurisdictions where the public can follow as Vivus tries to explain how Qsymia is a patentable drug:

* The United States Patent and Trademark (USPTO) as it considers the content of vivuspatent.wordpress.com; and

* The European Patent Office (EPO) where a third party observation was filed on August 6, 2013 that challenges Qsymia pharmaceutical composition and kit claims in light of the McElroy patent.

These are proxy battles likely to play out over near term that may foreshadow the larger battles that await Vivus if formal paragraph IV patent challenges are filed by one or more generics.

In the meantime, I expect another IDS to be filed for US Application No. 12/683,353 (the ‘353 application) when Mintz Levin responds to the Non-Final Rejection that was mailed in August 2013. This pending application is from the earlier-filed family of patents that names Dr. Thomas Najarian as the sole inventor, and it includes the issued Qsymia patents listed in the Orange Book. Since a majority of the vivuspatent blog is devoted to a discussion of the patentability and enforceability of this patent family, it seems highly likely a similar IDS will be filed for the ‘353 application (which is being examined by Leigh Maier). However, I expect the ‘353 IDS will also include the Mintz Levin Office Action Responses from the ‘540 and ‘548 applications that substantially undermine the enablement of the earlier Najarian patents, which is discussed in more detail here.

Footnotes

1 – A set of nearly identical prosecution documents was re-submitted on September 19th in the 12/481,540 case to correct for a minor, non-compliant claim amendment identified by the Examiner in the September 16th documents.

2 – A copy of the IDS, which appears to be identical for each application, can be found here, and the entire prosecution history for both applications can be viewed by visiting the USPTO’s Patent Application Information Retrieval (PAIR) site and entering the above application number.

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