Email to Mintz Levin re: 2007 Vivus Conference Call

by bobbydiggs

The below email was sent to Mintz Levin on November 7th. It discusses the discovery of a 2007 Vivus conference call that may affect the patentability of two recently allowed Qsymia patent applications (US Application Nos. 12/481,540 and 12/481,548).

Dear Mintz Levin Attorneys,

I would like to call your attention to a Vivus 8-K from November 9, 2007 that contains information that may be material to the prosecution of Vivus’ Qsymia patents, especially US Application Nos. 12/481,540 and 12/481,548.  In specific, Exhibit 99.1 from the 8-K is a transcript of the company’s Q3 2007 Earnings Conference Call, during which two of the inventors from the ‘540 and ‘548 applications (Mr. Wilson and Mr. Tam) discuss, among other things, the details of Qsymia’s once-a-day formulation and dosages. Your firm may feel a need to disclose Exhibit 99.1 to the USPTO for any one or more of the following reasons:

  1. The disclosure predates the earliest filing of the ‘540 and ‘548 priority application (12/135,953).
  2. It does not appear Exhibit 99.1 has been previously disclosed to the USPTO, for example, in an information disclosure statement (IDS).
  3. The specific dosages of Qsymia are disclosed.
  4. The motivation for the once-a-day formulation, namely improved compliance and an allegedly reduced side effect profile, is disclosed.
  5. Mr. Tam’s statement that, “Pharmacokinetics and pharmacodynamic studies have confirmed that the final formulation of Qnexa is comparable with the twice-a-day formulation that was used in the Phase II study conducted at Duke University,” is disclosed. On the conference call, Mr. Tam later states the once-a-day formulation “has the exact dosing, timing and exposure relative to what was done in the Phase II study.”
  6. Reference is made to Dr. Najarian’s extensive prescribing history with the drug combination, which includes the treatment of 10,000 patients.

While the inventors of the ‘540 and ‘548 applications may be able to swear behind the 8-K, it is likely the patent examiner of the application would find the disclosure, especially points 4, 5 and 6, material to patentability — whether the reference is sworn behind or not.

More specifically, from the conference call we learn that the once-a-day formulation, which is largely the subject of the ‘540 and ‘548 applications, has the exact same dosing, timing and exposure as the twice-a-day formulation used in the phase 2 trial. This simple twice-a-day formulation seems to be based on Dr. Najarian’s earlier patents (see the Examples section), the earliest of which is cited throughout the prosecution of the ‘540 and ‘548 applications.

In light of this, how can the once-a-day formulation offer anything that is surprising or unexpected? Was it formulated primarily for convenience and compliance?

Presumably the ‘540 and ‘548 applications were allowed based on the September 16, 2013 declaration signed by Peter Tam and the subsequent examiner interview (on September 27, 2013) that convinced the examiner that the dosages and formulation of once-a-day Qsymia provide for surprising and unexpected properties. In my view, these arguments directly contradict the earlier statements made by Mr. Tam on the conference call. Specifically, the declaration states, “The specific formulation and specific dosage ranges and dosage ratio of the combination of phentermine and topiramate…are not taught or suggested by the cited reference.” (See page 3, section 7). Later, Mr. Tam declares, “Importantly, the pharmacokinetics profile of the claimed unit dosage forms surprisingly permits 24 hour coverage of phentermine and topiramate (thereby suppressing appetite and enhancing satiety throughout the day).” (See page 4, section 7). Both of these statements seem to be at odds with point 5 above.

And when you add Dr. Najarian’s 10,000 patient experience with the drug combination (with dosages, formulations, safety and outcomes that have never been disclosed to the USPTO), the hurdle for demonstrating surprising and unexpected results may become even higher in light of the missing data from this extensive public use. The examiner cannot make the necessary comparison between the prior art (Exhibit 99.1 and Dr. Najarian’s extensive prior use) and the features (e.g., dosing, timing and exposure) of the once-a-day formulation because the critical data has not been disclosed.

Would Dr. Najarian, also an inventor on the ‘540 and ‘548 applications, be able to sign Mr. Tam’s declaration under penalty of perjury? Which of Mr. Tam’s statements would the examiner believe if given all of the prior art? How is a federal judge going to view this, particularly if it is not disclosed to the examiner?

Given all of these facts, it seems to me that you, the inventors and your client are ethically obligated to pull these applications from issuance and provide the examiner with the whole story, including the transcript from the November 9, 2007 conference call and a summary of the results from Dr. Najarian’s experience treating 10,000 patients at his weight loss clinic.

Respectfully,

Robert F. Diggs

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