IN THE CIRCUIT COURT FOR MONTGOMERY COUNTY, MARYLAND
`
`LEWIS J. RUBIN,
`
`Plaintiff,
`
`v.
`
`
`
`
`
`Case No. 43 l 672-V
`
`Hon. Gary E. Bair
`Track 4 Judge
`
`UNITED THERAPEUTICS CORPORATION, et (11.,
`
`Defendants.
`
`AFFIDAVIT OF LEWIS J. RUBIN
`
`1.
`
`I, Dr. Lewis J. Rubin, plaintiff in the above-identified action, am over eighteen years
`
`of age and competent to testify.
`
`I am fully familiar with and have personal knowledge of the facts
`
`set forth in the Complaint and in this Affidavit.
`
`2.
`
`I respectfully submit this Affidavit in opposition to Defendants United Therapeutics
`
`Corporation (“UTC) and Lung Biotechnology PBC’s Motion for Award of Costs and Expenses.
`
`3.
`
`Defendants assert that my assertion ofclaims in this action is “a brazen attempt to
`
`extort UTC" for compensation for patent rights that I “knowingly assigned” to UTC. This assertion
`
`is untrue and disregards claims that l assert in the Complaint for reformation of the assignments
`
`based on mutual mistake to recognize that l have an undivided interest in the patents rights in
`
`dispute.
`
`4.
`
`Defendants mischaracterize my association with UTC and Dr. Martine Rothblatt
`
`(“‘Dr. Rothblatt”), the company’s founder and CEO.
`
`I have more than a 20-year friendship and
`
`business relationship with Dr. Rothblatt. Beginning in 1995, I worked with Dr. Rothblatt at PPH
`
`Cure Foundation, a non-profit foundation to promote research in PAH. After the founding of UTC
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 1 of 7
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 1 of 7
`
`

`

`in 1996, Dr. Rothblatt asked me to work with the company as a consultant. During my 20-year
`
`tenure with UTC, I entered into a number of consulting agreements with UTC and played a central
`
`role in developing UTC’s line drugs of drugs for treating pulmonary arterial hypertension (“PAH").
`
`5.
`
`By the early Fall of2003. 1 conceptualized the invention which is the subject of the
`
`patent rights at issue in this case — the treatment of PAH by administration of treprostinil by a
`
`metered dose inhaler or pulsed nebulizer. An aspect of the invention, which I believe is critical is
`
`the delivery of the medication in a single event consisting of fewer than 18 breadths.
`
`6.
`
`Thereafter, in mid-September 2003. I met Dr. Rothblatt for lunch while she was in
`
`the San Diego area visiting family. At that time, I was a Professor at the University ofCalifomia,
`
`San Diego School of Medicine and resided in San Diego. At the luncheon, I disclosed my new
`
`invention to Dr. Rothblatt. We agreed to enter into a consulting agreement to pursue clinical trials
`
`relating to the invention.
`
`7.
`
`In late September. I signed a Services Agreement (“2003 Services Agreement") with
`
`Lung Rx (now defendant Lung-Bio, a UTC subsidiary) which provided for the conduct ofclinical
`
`trials with a view to obtaining FDA approval for my invention. (Compl., Ex. 4). This program was
`
`designated the TRIUMPH program (Bepostinil Inhalation Qse for the Management of Pulmonary
`
`Arterial Hypertension). It was my firm understanding that I had at least a co-ownership interest in
`
`any patents resulting from the TRIUMPH program because I conceptualized the invention on my
`
`own and not as a consultant for UTC. When I met with Dr. Rothblatt, I had fully conceptualized the
`
`invention and it required only routine experimentation through clinical trials to permit FDA review.
`
`8.
`
`When I executed the 2003 Services Agreement it was my understanding that l was
`
`required to assign to UTC patentable inventions that I conceived while working as a consultant for
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 2 of 7
`
`2
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 2 of 7
`
`

`

`UTC. However, as I stated above, it was my firm view that I conceptualized and brought the
`
`invention to Dr. Rothblatt prior to entering into the 2003 Services Agreement.
`
`9.
`
`The Court determined that the Ownership provision in the 2003 Services Agreement
`
`requires me to assign my invention to UTC because it was conceived "in whole or part" under the
`
`2003 Services Agreement. Contrary to the Court’s decision, it was my understanding that I was
`
`required to assign inventions or improvements in my invention that I conceived in my role as
`
`consultant under the 2003 Services Agreement. In all events, my invention pre-dates the 2003
`
`Services Agreement.
`
`10.
`
`Under the 2003 Services Agreement, I assisted UTC in organizing a team for
`
`clinical trial work which led to FDA approval.
`
`I also cooperated with UTC in the prosecution of
`
`patent applications for my invention which issued as US. Patent No. 9,339,507 and US. Patent No.
`
`9,358,240 ("the ‘507 and ‘240 patents”).
`
`I now understand that l executed two assignment
`
`documents — one for a provisional application, dated July 24, 2006, and a second for a formal patent
`
`application, dated June 1 l, 2007.
`
`I did not have these documents in my files. My current attorneys
`
`located the assignments at the United States Patent and Trademark Office’s website and provided
`
`me with copies of the assignments for review. Although I executed various formal documents for
`
`the patent filings, I had no understanding that these documents included an assignment of my patent
`
`rights.
`
`1 I.
`
`At my attorneys’ office, I reviewed the assignment dated June 1 1, 2007.
`
`1
`
`determined that I executed this document at UTC’s corporate offices in Silver Spring, Maryland.
`
`On June 11, 2007, 1 attended an all-day conference at UTC’s corporate offices to review the status
`
`of the TRIUMPH development program, and trial data for presentation to the FDA. In attendance at
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 3 of 7
`
`3
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 3 of 7
`
`

`

`the conference were Dr. Rothblatt, Eugene Sullivan, the Chief Medical Officer of Lung-Rx, and Ted
`
`Staub, Lung Rx’s executive responsible for implementing the TRIUMPH development program.
`
`(Compl. 1] 47).
`
`12.
`
`At the conclusion of the conference, as I was leaving for the airport, Dr. Rothblatt
`
`asked me to sign documents relating to a formal patent application for my invention. Records of the
`
`US. Patent and Trademark Office disclose that these documents included a Declaration of
`
`Invention and the assignment of my patent rights.
`
`1 executed these documents without review based
`
`upon my understanding from discussion with Dr. Rothblatt that the documents were in good order.
`
`I have a longstanding relationship of trust with Dr. Rothblatt and generally deferred to her with
`
`regard to legal formalities. Dr. Rothblatt is an attorney.
`
`I did not read these formal patent
`
`documents and am confident that other participants present at the meeting will confirm my
`
`recollection. (See Compl. 1H] 45 — 55).
`
`13.
`
`The assignment of the provisional patent application was executed at my office in
`
`San Diego.
`
`I executed this document at UTC’s request and have no records relating to it. In all
`
`events, I always proceeded on the premise that I could trust Dr. Rothblatt and UTC to attend to
`
`necessary legal formalities. (Compl. 1H] 43 — 44).
`
`First Knowledge of Claims
`
`14.
`
`On February 1, 2016, UTC’s patent attorneys sent me an e—mail requesting that I
`
`execute additional documents relating to patent filings for my invention.
`
`I responded by e-mail
`
`requesting an explanation of the documents and status of my patent applications. UTC‘s patent
`
`counsel advised by e-mail that 1 had assigned to UTC all my rights in my invention. UTC‘s
`
`counsel advised that the additional patent document was a Declaration of Invention for a further
`
`4
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 4 of 7
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 4 of 7
`
`

`

`patent application claiming priority to my earlier patent applications. (Compl., 1H] 56 — 58).
`
`After learning from UTC that the Declaration was a formality, I signed and returned it to UTC’s
`
`patent counsel.
`
`15.
`
`In early March of20 l 6, I retained Glenn F. Ostrager of the firm ofOstrager
`
`Chong Flaherty & Broitman PC. to advise me in this matter. At that time, my primary interest
`
`was to engage in a discussion with Dr. Rothblatt to address my concerns about the assignments.
`
`Also, I had conceptualized a new invention relating to a PAH drug which I wanted to discuss
`
`with Dr. Rothblatt. Mr. Ostrager recommended that 1 file a Provisional Application prior to my
`
`meeting. On April 1, 2016, an attorney in Mr. Ostrager’s firm filed the Provisional Application.
`
`16.
`
`On April 5, 2016. I met with Dr. Rothblatt in New York for lunch to discuss this
`
`matter.
`
`I invited my colleague Werner Seeger to attend the meeting. Dr. Rothblatt advised that the
`
`assignments relating to my invention were binding legal documents. Accordingly, she stated that it
`
`would be difficult for UTC to provide compensation for my contributions beyond the payments that
`
`I had received for my consultation work. Nevertheless, Dr. Rothblatt advised that she wished to
`
`discuss a new consulting agreement.
`
`17.
`
`On May 31, 2016, I sent Dr. Rothblatt an e-mail to follow up our discussions at our
`
`April luncheon.
`
`I did not consult with Mr. Ostrager regarding this communication. In this e-mail, I
`
`expressed the state of affairs that then existed based on the actual wording ofthe assignments and
`
`based on what Dr. Rothblatt had told me at the April 5 meeting, and again requested that UTC agree
`
`to a "signing bonus” for a new consulting agreement to account for my prior contributions to the
`
`company. Contrary to Defendants‘ assertion in its motion, 1 did not acknowledge that I
`
`"knowingly” assigned my rights to UTC in ‘507 and ‘240 patents, that the assignment documents,
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 5 of 7
`
`5
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 5 of 7
`
`

`

`as written, accurately reflected the parties‘ intent, or that I was waiving a claim to reform the
`
`assignments to accurately reflect the parties’ intent.
`
`I was simply trying to acknowledge that which
`
`Dr. Rothblatt stated at our meeting, and the fact that, as worded in the assignments, I did not have
`
`rights in the two patents. The purpose of the April 5 meeting was to resolve in an amicable fashion
`
`my concerns about the assignments, and to preserve what had been a valued personal and
`
`professional relationship.
`
`I wrote the May 31 email for the same purpose.
`
`It would not have been
`
`consistent with my purpose to write an antagonistic email alleging that the assignments were
`
`improperly procured from me. Further, I do not believe that I have taken any position in this
`
`litigation that is inconsistent with whatI wrote in my May 3] e-mail to Dr. Rothblatt. As I
`
`understand the Complaint, our claims are based on the premise that I assigned away my rights
`
`pursuant to the assignment documents. That is why, as I understand it, my Complaint seeks
`
`reformation of those assignments, that is, to restore my rights.
`
`18.
`
`On June 29, 2016, UTC advised that it was prepared to enter into a new consulting
`
`agreement but would not provide a signing bonus or other compensation beyond my normal hourly
`
`rates.
`
`19.
`
`On July 7, 2016, I met with Mr. Ostrager and authorized his firm to undertake a
`
`further due diligence investigation to determine whether I could properly pursue legal remedies. As
`
`set forth in my counsel’s accompanying affidavit, UTC through its counsel declined to engage in a
`
`further dialogue about the assignment issues.
`
`20.
`
`I worked closely with Mr. Ostrager, and his colleagues in their due diligence
`
`investigation.
`
`21.
`
`On April 3. 2017, my attorneys filed the Complaint in this action. The Complaint
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 6 of 7
`
`6
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 6 of 7
`
`

`

`seeks reformation of the assignments to reflect what I believed was the parties‘ intent and recognize
`
`that, as a named co-inventor in the ‘504 and '240 patents, l have a pro rata undivided in the patents
`
`with UTC.
`
`I reviewed several iterations of the Complaint to ensure. to the best of my ability, that
`
`the Complaint is factually accurate. My only purpose for filing the Complaint was to vindicate what
`
`I believe to be are my rights in the ownership of the patents related to the invention I conceived
`
`prior to my meeting with Dr. Rothblatt in September, 2003.
`
`22.
`
`Based upon advice of counsel, I am pursuing an appeal of this Court’s decision
`
`dismissing the Complaint.
`
`I SWEAR AND AFFIRM UNDER THE PENALTIES OF PERJURY THAT THE
`
`CONTENTS OF THE FOREGOING PAPER ARE TRUE TO THE BEST OF MY
`KNOWLEDGE. INFORMATION AND BELIEF.
`
`Dated: November 14, 2017 ML WIS J. RUBIN, MD.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 7 of 7
`
`7
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1171, p. 7 of 7
`
`