RNAi Litigation

Archive for September, 2011

from Sherk

Barry Greene’s letter to Mark Murray which Alnylam has filed with their response might be relevant here. In that letter, Greene asks Murray to agree that MC3 be withheld from their newly inked collaboration with Pfizer:

“In particular, we would like to confirm that your work with Pfizer will not include any of the lipids to which Alnylam has exclusive rights (subject to your license for specific targets), including XTC and MC3.”

Was Tekmira unaware of MC3’s composition at the time of this letter (which Murray signs)? At what point did Tekmira begin to have a problem with Alnylam’s rights to these lipids?

Personally, I believe the lawsuit has its origins at least partially in the slackening of interest in RNAi among big pharma. With Roche and Pfizer pulling up stakes (among others) the remaining RNAi companies are left to fight over a smaller number of partnering opportunities. Perhaps the pie no longer seems large enough to share.

Added by JL: “…notwithstanding its inflammatory accusation that Alnylam “stole” MC3, Tekmira’s CEO previously acknowledged in writing that Alnylam has exclusive rights in MC3. See Exhibit 1 attached hereto (click to enlarge), a true and accurate copy of a letter dated March 17, 2010 from Barry E. Greene, President and Chief Operating Officer of Alnylam Pharmaceuticals, Inc. to Mark Murray, President and Chief Executive Officer of Tekmira Pharmaceuticals Corporation. It is remarkable that Tekmira aims to hoodwink this Court by failing to mention that acknowledgment, its covenant not to sue, its waiver of restrictions on the AlCana founders, and the agreed upon research plan in the Supplemental Agreement.”

‘Hell hath no fury like a lipid scientist scorned’ and ‘Hell hath no fury like a corporate partner scorned’

[from Tekmira and Protiva’s response to AlCana’s counterclaims filed August 4, 2011]

Para 24: “Tekmira admits that the Supplemental Agreement included a detailed research plan that described the work that was contemplated to be conducted among AICana, Alnylam, and UBC, and that the SRA was attached to the Supplemental Agreement as an exhibit. Tekmira admits that the workplan attached to the SRA disclosed that the parties would be designing and synthesizing over 100 novel lipids and identified the AICana scientists who would be working on the research collaboration.”

Para 30: “Tekmira admits SRA was attached to the Supplemental Agreement as an exhibit, and that the workplan attached to the SRA disclosed that the parties would be designing and synthesizing over 100 novel lipids and identified the AICana scientists who would be working on the research collaboration.”

Para 40: “Tekmira admits SRA was attached to the Supplemental Agreement as an exhibit, and that the workplan attached to the SRA disclosed that the parties would be designing and synthesizing over 100 novel lipids.”

Para 75: “As alleged by AICana, the SRA was attached to the Supplemental Agreement as an exhibit, and that the workplan attached to the SRA represents that AlCana would be designing and synthesizing novel lipids, not lipids or other research based on and/or derived from Tekmira information and technology. In response to Tekmira’s concerns about the improper use of Tekmira information, AICana and Alnylam represented to Tekmira that AICana would explore new structures, not structures that contain, were based on, and/or derived from Tekmira information.”

Para 77: “Tekmira relied on these representations and omissions in agreeing to the Supplemental Agreement. AlCana’s contemporaneous representations are consistent with its 15 counterclaim allegation that Tekmira was under the impression that scientists who had previously worked for Tekmira in developing LNPs would be conducting further research in collaboration with Alnylam looking for ‘new novel LNPs’.”

This below is the Supplemental Agreement found on the 8-K Form filed by Alnylam with the SEC on July 29, 2011. This is the agreement formed by the five parties on July 27, 2009.

From the SEC 8-K form filed on April 7, 2011:
“47. In order to avoid disputes and clarify the parties’ rights, Alnylam, Tekmira, Protiva, UBC, and AlCana entered into a Supplemental Agreement dated July 27, 2009 (“Supplemental Agreement”), which explicitly contemplated that the AlCana scientists would create novel lipids by performing work to optimize lipids that had originated at Tekmira and had been exclusively licensed to Alnylam. The agreement provided that some such novel lipids would be licensed to Alnylam through UBC and Tekmira, and certain other novel lipids would be assigned to Alnylam. In either case, Tekmira would have access to such lipids for use with respect to the products it was developing pursuant to a license to Alnylam’s RNAi technology.
48. In the Supplemental Agreement, Tekmira waived all prohibitions and restrictions on the former Tekmira employees in connection with their performance of research to discover novel lipid formulations under the research plan agreed to by all parties and granted Alnylam, AlCana, UBC and the former Tekmira employees a covenant not to sue for any cause of action relating to such activities that arose out of their former employment with Tekmira.”

“Alnylam — Tekmira — Protiva — UBC — AlCana
Supplemental Agreement
Effective July 27, 2009

This Supplemental Agreement is made by and among Alnylam Pharmaceuticals, Inc. (”Alnylam”), Tekmira Pharmaceuticals Corporation (”Tekmira”), Protiva Biotherapeutics Inc., a wholly-owned subsidiary of Tekmira (”Protiva”), the University of British Columbia (”UBC”), and AlCana Technologies, Inc. (”AlCana”), as of the effective date stated above.

Background
A. Alnylam, UBC, AlCana, Tekmira and Protiva have a variety of relationships with one another, including the following:

1. UBC has, pursuant to a License Agreement between Tekmira (as successor in interest to INEX Pharmaceutical Corporation) and UBC dated effective July 1, 1998, as amended by an Amendment Agreement dated effective as of July 11, 2006, and a Second Amendment Agreement dated effective January 8, 2007 (the “UBC-Tekmira License Agreement”), granted Tekmira an exclusive license to certain Technology (as such term is defined therein).

2. Tekmira has, pursuant to a Sublicense Agreement dated effective January 8, 2007 between Tekmira (as successor in interest to INEX Pharmaceutical Corporation) and Alnylam (”UBC Sublicense Agreement”), exclusively sublicensed certain of this Technology to Alnylam.

3. AlCana has been formed and is staffed in part by former Tekmira employees. These individuals are bound by the agreements listed on Exhibit A (collectively, the “Employment Agreements”) that, among other things, bind them not to use or disclose certain Tekmira (or Protiva) confidential information or trade secrets.

4. Alnylam, UBC and AlCana desire to enter into a lipid discovery collaboration pursuant to the Sponsored Research Agreement dated of even date herewith (”Research Agreement”), a copy of which is attached to this Supplemental Agreement as Exhibit B, and desire to begin work under the Research Program as soon as possible.

5. Alnylam has entered into Consulting Agreements with the individuals defined in the Research Agreement as “Consultants” (the “Consulting Agreements”), redacted copies of which have been provided to Tekmira and Protiva.

6. Alnylam has, pursuant to the Amended and Restated License and Collaboration Agreement between Tekmira and Alnylam effective as of May 30, 2008 (the “Alnylam-Tekmira License Agreement”), granted to Tekmira an exclusive license to certain Alnylam intellectual property for the purpose of developing certain products directed to the targets identified pursuant to the Alnylam-Tekmira License Agreement.

7. Alnylam has, pursuant to the Amended and Restated Cross-License Agreement between Alnylam and Protiva dated May 30, 2008 (the “Alnylam-Protiva License Agreement”), granted to Tekmira a non-exclusive license to certain Alnylam intellectual property for the purpose of developing certain products directed to the targets identified pursuant to the Alnylam-Protiva License Agreement.

B. In addition to the relationships described by the foregoing (and others), Alnylam, UBC, AlCana, Tekmira and Protiva intend to enter into a new arrangement which will be governed by this Supplemental Agreement and, the extent provided herein, the Research Agreement attached
hereto. For clarity, the parties do not intend that anything in this Supplemental Agreement or the Research Agreement will constitute any extension or renewal of the “Collaboration” or the “Collaboration Term” as defined in the Alnylam-Tekmira License Agreement.

C. Capitalized terms used, but not otherwise defined, in this Supplemental Agreement shall have the meanings ascribed to such terms in the Research Agreement.

D. It is the intention of Alnylam, UBC, AlCana, and the understanding of Tekmira and Protiva, that Alnylam will fund research, described by a research plan, which research will be performed by Alnylam, AlCana, and UBC under the Research Agreement.

E. The intellectual property rights arising out of that research will be governed as set forth in this Supplemental Agreement and the Research Agreement. For clarity, but subject in all cases to the operative provisions of this Supplemental Agreement and the Research Agreement, it is the intention of the foregoing parties that the rights resulting from the research to be performed in accordance with this Supplemental Agreement and the Research Agreement, and the licenses and assignments described in this Supplemental Agreement and the Research Agreement, result in the following intellectual property rights, in principal outline:

1. Alnylam will have (subject to the rights granted by it hereunder to one or more of the other parties):

i. exclusive rights, with unlimited rights to sublicense, to any such intellectual property in the Field of Use,

ii. exclusive rights, with unlimited rights to sublicense, to intellectual property invented solely by Alnylam in all fields of use, including without limitation the Supplemental Field, and

iii. non-exclusive rights, with unlimited rights to sublicense, to intellectual property invented jointly by Alnylam, on the one hand, and UBC and/or AlCana, on the other hand, in all fields of use, including without limitation the Supplemental Field;

2. AlCana will have (subject to the rights granted by it hereunder to one or more of the other parties):

i. exclusive rights, with unlimited rights to sublicense, to intellectual property invented solely by AlCana in all fields of use, including without limitation, the Supplemental Field, but specifically excluding the Field of Use, in which Field of Use rights may be exercised exclusively by Alnylam, and

ii. non-exclusive rights to intellectual property invented jointly by AlCana, on the one hand, and UBC and/or Alnylam, on the other hand, in all fields of use, including without limitation the Supplemental Field, but specifically excluding the Field of Use, in which Field of Use rights may be exercised exclusively by Alnylam;

3. UBC will have (subject to the rights granted by it hereunder to one or more of the other parties):

i. exclusive rights, with unlimited rights to sublicense, to intellectual property invented solely by UBC in all fields of use, including without limitation the Supplemental Field, but specifically excluding the Field of Use, in which Field of Use rights may be exercised exclusively by Alnylam, and

ii. non-exclusive rights to intellectual property invented jointly by UBC, on the one hand, and AlCana and/or Alnylam, on the other hand, in all fields of use, including without
Confidential limitation the Supplemental Field, but specifically excluding the Field of Use, in which Field of Use rights may be exercised by Alnylam;

4. Tekmira will have:

i. exclusive rights to use intellectual property invented by AlCana and/or UBC under the Research Agreement (whether or not Alnylam is also an inventor of such intellectual property) in the Field of Use for the targets identified pursuant to the Alnylam-Tekmira License Agreement, with the sublicense rights described in the Alnylam-Tekmira License Agreement, and

ii. non-exclusive rights to use intellectual property invented by AlCana and/or UBC under the Research Agreement (whether or not Alnylam is also an inventor of such intellectual property) in the Supplemental Field for use against any target, with the sublicense rights described herein.

5. Protiva will have:

i. non-exclusive rights to use intellectual property invented by AlCana and/or UBC under the Research Agreement (whether or not Alnylam is also an inventor of such intellectual property) in the Field of Use for the targets identified pursuant to the Alnylam-Protiva License Agreement, with the sublicense rights described in the Alnylam-Protiva License Agreement, and

ii. non-exclusive rights to use intellectual property invented by AlCana and/or UBC under the Research Agreement (whether or not Alnylam is also an inventor of such intellectual property) in the Supplemental Field for use against any target, with the sublicense rights described herein.

F. It is also the intention of the foregoing parties that the intellectual property rights of Alnylam arising out of the Consulting Agreements will be licensed to AlCana exclusively in the Supplemental Field, and further sublicensed by AlCana to Tekmira and Protiva non-exclusively in the Supplemental Field.

G. The foregoing Sections E and F are statements of intent only. They are intended to elucidate the end result of the complicated licenses and assignments described herein, and are not intended to replace any of the specific language or structures described in this Supplemental Agreement, the Research Agreement or any of the foregoing agreements.

Agreement
The parties to this Supplemental Agreement, for good and sufficient consideration acknowledged to be received, hereby agree as follows:

1. Licenses to UBC Controlled IP. All UBC Controlled IP are hereby exclusively licensed to Tekmira as follows:

(a) All UBC Controlled Patent Rights that claim priority to the “Patents” (as such term is defined in the UBC-Tekmira License Agreement) (collectively, “Schedule A IP”), shall be added to Schedule A of the UBC-Tekmira License Agreement and the terms and conditions of the UBC-Tekmira License Agreement (including, without limitation, the financial terms and conditions of such agreement) shall apply to such Schedule A IP. Read the rest of this entry »

Tekmira Ignores the Supplemental Agreement

By the Supplemental Agreement, Tekmira had been explicitly informed of AlCana’s ongoing LNP (lipid nanoparticles) research in collaboration with Alnylam.

“Out of an abundance of caution because AlCana was aware of Tekmira’s propensity for litigation and wanted to avoid the possibility of a meritless and distracting lawsuit, the three parties to the SRA concurrently negotiated and entered into a Supplemental Agreement among AlCana, Alnylam, UBC, Tekmira, and Protiva.” From PART 2

Tekmira was well aware that the same scientists who previously had worked for Tekmira in developing LNPs would be conducting further research in collaboration with Alnylam looking for new novel LNPs for delivery of siRNA therapeutics. Tekmira entered into the Supplemental Agreement with full understanding of what its former employees planned to do. Moreover, in exchange for receiving certain rights to intellectual property that might be developed by Alnylam and AlCana under the SRA, Tekmira expressly agreed to wave any remaining restrictions it may have retained under AlCana’s employees’ old employment agreements with Tekmira and it agreed not to sue AlCana, UBC, or Alnylam relating to research under the SRA or the Consulting Agreement.

In blatant disregard of its expressed promises under the Supplemental Agreement, Tekmira brought this suit, alleging inter alia, that it should be entitled to greater rights in intellectual property developed under the SRA research plan than contemplated by the Supplemental Agreement. In essence, Tekmira has decided with hindsight that it doesn’t like the Supplemental Agreement so it is attempting to use litigation to re-write the covenants not to sue and the forum selection clause.

Tekmira pursues these frivolous claims without any reasonable basis of fact or law. Upon information and belief, Tekmira asserts its claims for the sole purpose of bullying AlCana, a small competitive start-up that has made important discoveries in LNP technologythat maked Tekmira’s own technology obsolete or less valuable.

One nagging question that arises throughout reading the different chapters of this story is as follows: Why did Tekmira fire the scientists that then formed AlCana? Tekmira infers that the non-compete clause of their employment contracts with Tekmira should prevent these ex-Tekmira employees from doing the research in spite of the assertions by AlCana as describe below. JL

Discovery of MC3

In accordance with the terms of their Consulting Agreements with Alnylam, and after July 27, 2009, also with the SRA and Supplemental Agreements, the Consultants/AlCana Employees designed and tested numerous lipids as possible nucleotide delivery systems. For example, acting in close consultation with Alnylam, the team designed and synthesized certain M-series lipids with longer carbon linker chains than the MC2, the M-series lipid that had been developed by Tekmira. The basic structure of these M-series compounds was publicly known, having been disclosed in prior publications and, subsequently, in the (Tekmira) ‘887 Application.

The Consultants began their work with the M-series lipids by synthesizing MC3. They did not synthesize MC2 because they were aware from their prior wok with MC2 (the same work that was publicly disclosed in the ‘877 Application) that MC2 was less active than the K-series lipids. When the team tested MC3, they discovered that MC3, unlike MC2, was much more potent than even the best K-series lipids. This result was surprising and unexpected, particularly in view of the K-series data suggesting that longer carbon linker chains would result in lower potency.

The Consultants shared this important discovery concerning MC3 with their research partners at UBC and Alnylam. Upon information and belief, Alnylam informed Tekmira of this breakthrough in LPN technology.

PART 5 will follow. JL

Specifically, Tekmira and Protiva expressly agreed to “waive all prohibitions and restrictions upon… each former Tekmira employee who is subject to the provisions of an Employment Agreement arising out of, under, or in connection with their former employment by Tekmira, to the extent that any activities of such former Tekmira employees are carried out pursuant to the Research Program, the Consulting Agreements or in connection with the performance of obligations or the exercise of rights under this Supplement Agreement.”

Tekmira and Protiva also convenanted “not to sue Alnylam, UBC, or AlCana or any of the former Tekmira employees employed by AlCana or UBC, for any cause of action relating to such activities that arises out of, under or inconnection with the former employment by Tekmira of such former Tekmira employees.”

The Research Plan provided to Tekmira with the Supplemental Agreement contemplated a comprehensive research program designed to develop novel lipids. Nothing in the Supplemental Agreement suggested any limits on the right to experiment with M-series lipids (other than MC2) that were outside the scope of the lipids that had been developed by the AlCana Employees when they previously worked at Tekmira.

Finally, the parties to the Supplemental Agreement agreed that “the courts of British Columbia shall have exclusive jurisdiction over the interpretation and enforcement” of the agreement.

PART 4 will follow. JL

In February 2009, AlCana was founded by Madden, Chen , Cullis, and Hope. AlCana is an independent company and is controlled and operated in the interests of its employees and shareholders. AlCana conducts research in collaboration with several research partners, as well as conducting its own internal research programs. Alnylam is one of AlCana’s research partners.

In order to continue the ongoing research of its founders, AlCana sought to formalize its research collaboration concerning lipid nanoparticles (LNP) with Alnylam and The University of British Columbia (“UBC”). The three parties negotiated a Sponsored Research Agreement (“SRA”) governing the rights and obligations of each party related to their LNP collaboration.

Out of an abundance of caution because AlCana was aware of Tekmira’s propensity for litigation and wanted to avoid the possibility of a meritless and distracting lawsuit, the three parties to the SRA concurrently negotiated and entered into a Supplemental Agreement among AlCana, Alnylam, UBC, Tekmira, and Protiva. Both the Supplemental Agreement and the SRA have an effective date of July 27, 2009.

On the effective date of the SRA and Supplemental Agreement, July 27, 2009, the Consulting Agreements between Alnylam and each of Madden, Hope, Chen, Tam, Mui, and Ansell were terminated and these scientists signed employment agreements with AlCana.

AlCana, Alnylam, and UBC sought the agreement with Tekmira and Protiva regarding the SRA in order to avoid any future disputes over the research conducted under it. Consequently, it was of the utmost importance to make it clear what that research would encompass and what each party’s respective rights would be with respect to the results of the research. To that end, the Supplemental Agreement included a detailed research plan that described the work the work that was contemplated to be conducted among AlCana, Alnylam, and UBC. The SRA was attached to the Supplemental Agreement as an exhibit. Furthermore, the workplan attached to the SRA and provided to Tekmira disclosed that the parties, led by AlCana, would be designing and synthesizing over 100 novel lipids for the delivery of siRNA oligonucleotides. The workplan also specifically identified the AlCana scientists who would be working on the research collaboration.

In AlCana’s effort to disclose and address all relevant facts, the Supplemental Agreement also covered the Consultants’ ( all of whom became AlCana employees as of the effective date of the SRA and Supplemental Agreement, and may hereinafter be alternatively referred to as “AlCana Employees”) obligations under their prior employment agreements with Tekmira and the existence and terms of the AlCana Employees’ Consulting Agreements with Alnylam.

After being made aware of the scope of the research conducted under the SRA, who it would be conducted by, and the rights to intellectual property arising from the research, Tekmira and Protiva entered into the Supplemental Agreement.

By the Supplemental Agreement, Tekmira and Protiva agreed to waive restrictions arising from the AlCana Employees’ old employment agreements with Tekmira. In so doing Tekmira expressly consented to AlCana Employees continuing their ongoing collaboration with Alnylam aimed at developing novel LNPs for the delivery of siRNA therapeutics.

In February 2009, AlCana was founded by Madden, Chen , Cullis, and Hope. AlCana is an independent company and is controlled and operated in the interests of its employees and shareholders. AlCana conducts research in collaboration with several research partners, as well as conducting its own internal research programs. Alnylam is one of AlCana’s research partners.

In order to continue the ongoing research of its founders, AlCana sought to formalize its research collaboration concerning lipid nanoparticles (LNP). With Alnylam and The University of British Columbia (“UBC”). The three parties negotiated a Sponsored Research Agreement (“SRA”) governing the rights and obligations of each party related to their LNP collaboration. Read the rest of this entry »

I went to the Suffolk County Superior Courthouse on Pemberton Square in downtown Boston this week. The experience inside the building reminded me of the early 1990’s when I would wander over to the Lane Medical Library at Stanford to look for research papers of interest without the help of the Internet. As far as I can tell there is no useful Internet site where one can download Superior Court documents like PACER where all documents are available for Federal cases. Tekmira filed its lawsuit against Alnylam in March in the Business Litigation Session of the Suffolk County Superior Court accusing Alnylam of stealing their RNAi delivery technology.

I went up to the 12th floor to find the file for this case. After looking through the cabinet that holds all the case files, the clerk went upstairs and found the case file in one of the cubicles where you could sit and read to your heart’s delight. Apparently this case is a big deal because the file, a thick folder and a box of exhibits, is left out on a table.

It would have been an impossible task for me to read through all of the papers because of another commitment (and my real job) so I focused in on Alcana Technologies’ response to Tekmira’s amended complaint. I learned also that a hearing was scheduled in October which I will try to attend.

PART 2 will follow tomorrow

The Background of this case against Alnylam and partner, Alcana in Vancouver British Columbia

In 2006, Alnylam Pharmaceuticals (“Alnylam”) began collaborating with Tekmira Pharmaceuticals and Protiva Biotherapeutics (referred to here as “Tekmira”) on research regarding certain lipid carriers for delivery of Alnylam’s proprietary siRNA compounds. siRNA can be used as therapeutic agents by acting to interfere with or silence disease-carrying genes. One difficulty in administering siRNA is developing ways to effectively get the compounds to the place in the body where they can be most effective without causing unwanted side-effects. The purpose of the Alnylam collaboration with Tekmira was to investigate the suitability of certain novel lipid nanoparticles (“LNPs”) or stable nucleic acid lipid particles (“SNALP”) as a means of administering Alnylam’s siRNAs.

Alnylam entered into collaboration agreements with Tekmira (Tekmira and Protiva) detailing the scope of their research programs and each company’s rights and obligations in intellectual property developed in the course of their research conducted under these agreements.

Following the execution of an Initial License and Collaboration Agreement in January 2007 between Tekmira and Alnylam, the two companies formed a joint agreement to engage in collaborative research regarding lipid carriers and siRNA delivery. Under this collaborative research program, Tekmira formed a team of scientists led by Dr. Thomas Madden, called the “Alnylam Research Group” to work with a similar team within Alnylam.

Tekmira’s technology

During the period from January 2007 to October 2008, the Alnylam Research Group undertook the synthesis and testing of cationic lipids to identify molecules with improved properties as a part of its collaborative research with Alnylam.

The research focused on a class of cationic lipids referred to by the designation “DLin-K-DMA.” The Alnylam Research Group synthesized and tested many variations of these compounds, also known as “K-series” lipids. In the course of this research, the team discovered that adding a second carbon atom to the linker group of the molecule to form DLin-K-C2-DMA resulted in significant improvements in potency. Notably, the further addition of carbon atoms to the linker group – e.g., to produce DLin-K-C3-DMA or DLin-K-C4-DMA – resulted in loss of activity compared to DLin-K-C2-DMA. Based on these experiments, the team concluded that the most active linker group within the K-series lipids consisted of two carbon atoms.

The research program resulted in two patent applications by Tekmira (WO 2009 086558 and WO 2010 042877). The ‘887 application disclosed the chemical structure of the K-series lipids and data reflecting their activity, in particular, the superior potency of DLin-K-C2-DMA (referred to as “KC2”). The data contained in the patent application demonstrated that KC1 and KC2 showed the highest potency within the K-series class of LNPs tested by the Alnylam Research Group.

In addition to the K-series lipids, the Alnylam Research Group also experimented with a number of other cationic lipids. One of these compounds was referred to as DLin-M-DMA. This lipid was structurally similar to the K-series except that it did not contain a ketal group characteristic of the K-series (this lipid became known as an M-series lipid).The structure of this particular M-series lipid was disclosed publicly in the ‘877 Application. Like KC2, DLin-M-DMA contained a two-carbon linker (referred to as “MC2”) because that was the optimal linker length they had identified with the K-series lipids.

Upon information and belief, Tekmira did not synthesize or evaluate any M-series lipids, nor did it proceed with further development of MC2, which was less active than the K-series lipids.

Tekmira merges with Protiva and fires the Alnylam Research Group

While the Alnylam Research Group was continuing its research on the synthesis and testing of cationic lipids in collaboration with Alnylam, Tekmira merged with Protiva in May of 2008. Following the merger, former Protiva executives, Dr. Mark Murray and Dr. Ian MacLauchlan exercised executive control of the merged company, as CEO and CSO, respectively.

For several months after Tekmira merged with Protiva, the two companies kept their activities strictly separate as a result of contractual obligations to third parties. This period, known as the “Restriction Period,” ran from May 30, 2008, through October 9, 2008.

At the end of the Restriction Period, the members of the Alnylam Research Group, who had been long time employees of Tekmira, were abruptly and without reason fired by Tekmira.

On or about October 9, 2008, Tekmira filed patent applications in the USPTO reflecting the work conducted by the Alnylam Research Group. Those applications were ultimately published on April 15, 2010 as part of the ‘877 Application (not clear what is being said here, JL). Among other things, the ‘877 application published the data reflecting the superior potency of the KC2 lipid. It also disclosed the MC2 structure. By virtue of its publication, the information in the ‘877 Application does not and cannot constitute trade secrets (Tekmira claims that Alnylam stole trade secrets).

Ex-Tekmira Employees form Alcana Technologies

Tekmira’s abrupt termination of the employment of the principal scientists who had been working with Alnylam signaled that Tekmira was not interested in continuing the work that it had conducted through their Alnylam Research Group. Alnylam was, however, interested in engaging the now- unemployed ex-Tekmira employees including Madden, Chen Tam, Mui, and Hope, to continue their efforts to develop novel LNPs suitable for use in delivering siRNA therapeutics.

In late January 2009, each of this group together with Dr. Steven Ansell (collectively the “Consultants”) entered into consulting agreements with Alnylam (“Consulting Agreements”). Under these agreements, the Consultants expressly agreed not to use the confidential information or trade secrets of any third parties in their research. From the outset of their work, the Consultants were aware of their obligations not to use any confidential information of Tekmira and were careful not to do so

Court Instructions:

If a plaintiff, when filing an action, seeks to have a case accepted into the BLS (Business Litigation Session), the plaintiff shall file the case in the Suffolk County Civil Clerk’s Office and complete the BLS Civil Action Cover Sheet, articulating the reasons why the plaintiff believes the case should be accepted into the BLS. Failure to complete the BLS Civil Action Cover Sheet will result in the case being assigned to a Suffolk County Time Standards Session. A copy of the completed BLS Civil Action Cover Sheet shall be served on all defendants with the complaint. The complaint, with the BLS Civil Action Cover Sheet, shall be brought forthwith by the clerk to the BLS Administrative Justice, who will determine whether to accept the case into the BLS. Cases that fall within any of the following categories may be accepted into the BLS in the sound discretion of the BLS Administrative Justice, based principally on the complexity of the case and the need for substantial case management.

These are the claims that may be relevant to this case:

• claims relating to employment agreements
• claims relating to liability of shareholders, directors, officers, partners, etc.
• claims relating to or arising out of securities transactions
• claims to determine the use or status of, or claims involving, intellectual property
• claims to determine the use or status of, or claims involving, confidential, proprietary or trade secret information
• claims involving breaches of contract or fiduciary duties, fraud, misrepresentation, business torts or other violations involving business relationships
• claims of unfair trade practices involving complex issues

If a case is accepted into the BLS, the BLS Administrative Justice shall assign the case to either the BLS1 Session or the BLS2 Session. The Tekmira v. Alnylam case is in Session 2.

Thanks, Sherk for asking the question. We will attempt to answer additional questions posed by comments here.

If passed this month, how will this new law affect the Utah lawsuit against the owners of Tuschl I and II which was filed in March, amended in early July, and re-served in mid- July? Judge Saris has postponed the defendants’ response time to October 31.

From the Leahy-Smith America Invent Act (H.R. 1249) in it’s current state: “SEC. 35. EFFECTIVE DATE. Except as otherwise provided in this Act, the provisions of this Act shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act and shall apply to any patent issued on or after that effective date.”

From Attorney Scott Lloyd: “The new law, if signed by the President (and it looks like it will be), takes effect one year after the date of enactment and only applies to patents that issue on or after the effective date. If Tuschl I and Tuschl II issued already, the new law won’t impact them. If the bill was signed today, it would impact only patents that issue on or after September 12, 2012…as long as the text of the legislation isn’t changed again before enactment… only new filings with no claim of priority to Tuschl I and II would be affected by the new law.”

Correction from Scott: “The bill Obama signed into law provides that the first-to-file provisions take effect 18 months from enactment (which was 9/16). So, any patent that issues on St. Patrick’s Day 2013 or beyond will be affected.”

Foley & Lardner’s discussion on the impact of this patent reform act. HERE