Amgen Inc. v. F. Hoffmann-LaRoche LTD Et Al - Document No. 560
Amgen Inc. v. F. Hoffmann-LaRoche LTD Et Al - Document No. 560
Amgen Inc. v. F. Hoffmann-LaRoche LTD Et Al - Document No. 560
560
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 1 of 10
)
AMGEN INC., )
)
Plaintiff, )
)
v. )
) CIVIL ACTION No.: 05-CV-12237WGY
F. HOFFMANN-LA ROCHE LTD, )
ROCHE DIAGNOSTICS GMBH, )
and HOFFMANN-LA ROCHE INC., )
)
Defendants. )
)
Roche Inc. (collectively “Roche”) submit this memorandum and accompanying declarations in
support of their motion, pursuant to Local Rule 7.2 and the protective order, to file under seal
documents which contain Roche’s confidential and trade secret materials submitted for in
camera review by Amgen Inc. (“Amgen”) if the Court deems them necessary for its ruling on
Amgen Inc.’s Motion for Summary Judgment of Infringement of ‘422 Claim 1, ‘933 Claim 3,
As set forth in greater detail below and in the accompanying declarations of Dr. Michael
Jarsch (“Jarsch Decl.”), Dr. Krishnan Viswanidhan (“Viswanidhan Decl.”), and Susan Batcha
1
The documents Amgen seeks to file in the public record were submitted for in camera review on June 15, 2007
and correspond to Exhibits of the Declaration of Katie J.L. Scott in Support of Amgen Inc.’s Motion for Summary
Judgment of Infringement of ‘422 Claim 1, ‘933 Claim 3, and ‘698 Claim 6 (Docket No. 514), and the confidential
versions of Amgen’s memorandum of law (Docket No. 510), Statement of Facts Pursuant to Local Rule 56.1,
(Docket No. 512), and Declaration of Harvey Lodish (Docket No. 513).
Dockets.Justia.com
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 2 of 10
(“Batcha Decl.”), Roche’s exhibits 1-11, 14-16, 18-25, 28, 34-38, 41-45, 50-56, 59, 61-63, 65-68
(“the Exhibits”), which were submitted by Amgen for in camera review, contain sensitive and
highly confidential trade secret information, the public disclosure of which would irreparably
harm Roche’s position in the highly competitive pharmaceutical industry.2 Thus, Roche requests
that the Exhibits — and the trade secret information from the Exhibits contained in Amgen’s
filed under seal if the Court determines that they are necessary for its determination of the
underlying motion.
While Roche maintains all of the documents submitted for in camera review are
confidential, in light of the Court’s requirement that only trade secrets be filed under seal, it has
limited the present motion to the Exhibits listed above. To the extent that the Court finds any
exhibit (or portion of an exhibit) to be unnecessary in its determination of the underlying motion,
Roche respectfully requests that it not be filed at all, whether in the public record or under seal.
INTRODUCTION
As testified to by Dr. Jarsch, Dr. Viswanidhan, and Ms. Batcha, the Exhibits that Roche
is requesting to have filed under seal contain invaluable trade secrets regarding (1) Roche’s
proprietary manufacturing method, formulation, and technical characteristics for Mircera®, (2)
Roche’s proprietary methodology and results of its clinical and preclinical studies, (3) Roche’s
early development and feasibility studies, and (4) non-final, non-approved data and FDA
submissions, (5) confidential patient or third party information. Each of the Exhibits at issue
critical to the maintenance of Roche’s hard won competitive advantage in the highly competitive
2
In the accompanying declarations, Dr. Jarsch, Dr. Viswanidhan, and Ms. Batcha offer particularized testimony
regarding the trade secret status of each Exhibit. Attached as Appendix A is an index of which declarants speak to
which Exhibits.
2
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 3 of 10
pharmaceutical industry. For this reason, Roche considers the Exhibits to be its trade secrets and
procedure, formula, invention or improvement.” M.G.L. ch. 266 § 30(4);3 see Trent Partners
and Associates, Inc. v. Digital Equipment Corp., 120 F. Supp. 2d 84 (D. Mass. 1999)
(Woodlock, J.); In re Gabapentin Patent Litigation, 312 F. Supp. 2d 653, 659 and 667 (D.N.J.
2004) (affirming magistrate judge’s holding that “the parties’ products, research and
development, processes secret chemical formulas, the parties’ suppliers” constituted “clearly
protectable and highly confidential trade secrets” in pharmaceutical patent case). As asserted by
Dr. Jarsch, Dr. Viswanidhan, and Ms. Batcha, the Exhibits concern secret scientific information
belonging to Roche which, if revealed, would cause irreparable harm to Roche. See Jarsch Decl.
Trade secret status requires that reasonable steps be taken to keep the information
confidential. Here, Roche has never allowed the Exhibits or their contents to enter the public
domain and has taken all possible measures to ensure that the information contained therein
remains confidential. See Jarsch Decl. at ¶¶ 11-27; Viswanidhan Decl. at ¶¶ 12-31; Batcha Decl.
at ¶¶ 10-68.
3
M.G.L. ch. 93 § 42 incorporates by reference the definition of trade secrets found in M.G.L. ch. 266 § 30.
Additionally, a similar definition is found at M.G.L. c. 93 § 2.
3
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 4 of 10
III. If The Trade Secret Information In The Exhibits Were Revealed Publicly, Roche
Would Be Irreparably Harmed
11, 23, 25, 34, 41, 45, 50-53, 55, 56, 59, 63, 66, 67, and 68, which all relate to Roche’s
proprietary manufacturing methods, formulation, and technical characteristics for Mircera. The
confidential exhibits listed above are excerpts from (or contain information from) Roche’s
Chemistry, Manufacturing, and Controls (“CMC”) section of its highly confidential BLA and
INDs for Mircera, which contains specific detail information regarding the proprietary chemical
composition and the manufacturing process for Mircera. To obtain regulatory approval, the FDA
requires that the CMC section describe in exacting detail the step-by-step “recipe” for Mircera,
including the steps taken to insure the quality of the finished product, as well as a complete list
of the specifications for each component of the process. See 21 C.F.R. 314.50(d) (the CMC
sections is required “to contain data and information in sufficient detail to permit the agency to
make a knowledgeable judgment about whether to approve the application . . . [including] A full
description of the drug substance including its physical and chemical characteristics and stability
Thus, the CMC section is required to contain Roche’s most closely guarded trade secrets,
such as the precise formula and process for creating Mircera, as well as detailed descriptions
regarding such things as purification process, process controls, and data regarding the potency,
quality, purity, and bioavailability of the drug substance. This highly sensitive, confidential
information is the culmination of years of effort in the drug development process, and is the core
of Roche’s development efforts for Mircera. Indeed, the required disclosure of such sensitive
4
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 5 of 10
information is one of the principal reasons why the confidentiality of the BLA is insured by law.
Roche would be irreparably harmed if these exhibits were made public because they
without adequate patent protection — require to produce a product identical to Mircera. In the
CMC, Roche is effectively required to teach the FDA how to make Mircera, including specific
information regarding its chemical structure and biological activity, such as its potency and
purity. This, in turn, would teach generic drug manufactures and other competitors everything
they need to know to copy Mircera. Public disclosure of this information would destroy its trade
secret status and unfairly benefit Roche’s competitors, allowing them to gain this knowledge and
information without incurring the substantial effort and expense undertaken by Roche to develop
In addition, Roche would also be harmed if the information contained in the Exhibits
relating to its proprietary manufacturing process were made public. Roche commits significant
resources to optimizing its manufacturing process by experimenting with different ratios and
formulations of the reagents used in the various stages of manufacturing, such as fermentation,
amplification, and purification. These optimized processes give Roche a significant competitive
advantage by increasing the yield and potency of its product. The disclosure of this information,
however, would allow Roche’s competitors to use the fruits of Roche’s labor to optimize their
own manufacturing processes, thereby destroying Roche’s competitive advantage. See Batcha
Decl., ¶ 7.
Furthermore, Roche would also be harmed by the disclosure of the methodology and
results of its quality control testing that for Mircera. Roche expends significant resources
5
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 6 of 10
designing the specific parameters of its proprietary assays and in thoroughly testing its product at
various stages of the manufacturing process. Further, the data generated by these tests reveals
sensitive information about the potency, purity, and biological activity of Roche’s product. If
information contained in the Exhibits is made public, however, generic drug manufactures and
other competitors can avoid this expense by using the tests that Roche developed, thereby
Given the severe and irreparable harm that would befall Roche if its trade secrets
regarding its manufacturing process and product formulation and characteristics were revealed,
any documents which contain such information should be filed under seal.
Roche would be severely harmed if the trade secret information from Exhibits 1, 14-16,
18-23, 28, 37, 41, 44, 50, 52, 55, 59, 61, 62, and 65, which relates to its preclinical and clinical
studies, were publicly disclosed at the level of detail contained within the Exhibits. The results
of Roche’s preclinical and clinical studies, and Roche’s analysis of those results, reveal critical
potency, biological activity, and toxicity. Competitors, including generic drug manufacturers in
jurisdictions without adequate patent protection, could use this information in designing and
qualifying competing products. Furthermore, Roche invests a great deal of resources during its
rigorous preclinical and clinical testing regimes to gather the necessary data, which are
expenditures a competitor could forego if they have direct access to Roche’s data and analysis.
Thus, Roche would be harmed in the highly competitive pharmaceutical market were this
6
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 7 of 10
Roche would also be harmed by the disclosure of the methodology and results of the
preclinical and clinical studies that it has conducted on Mircera. In addition to the expense of
conducting the experiments, Roche expends significant resources designing the specific
parameters of its proprietary preclinical and clinical studies to maximize the efficiency of the
studies and the reliability of the results. Roche also expends significant resources in designing
its overall clinical and preclinical regimens to maximize the efficiency and speed of its drug
development process. The public disclosure of the information contained in the Exhibits would
thus unfairly benefit Roche’s competitors, such as generic drug manufactures, who could use it
to copy Roche’s proprietary studies, thereby avoiding the expense Roche has incurred in
developing its own preclinical and clinical protocols. See Jarsch Decl. ¶ 7; Viswanidhan Decl.
¶ 8.
Thus, because Roche would be harmed if its trade secrets regarding its preclinical and
clinical programs were revealed, any documents which contain such information should be filed
under seal.
Roche would be irreparably harmed if Exhibits 24, 35, 38, 42, 43, 54, and 65, which
contain highly confidential trade secret information regarding Roche's feasibility and early
development of Mircera, were disclosed to the public. Roche keeps information relating to the
selection and early development of potential drug candidates in the utmost secrecy and
confidence because potential competitors could use Roche’s early development efforts to speed
their own development process. Competitors with access to Roche information could avoid
Roche’s internally generated data. Also, they could use Roche’s data to select a product from the
7
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 8 of 10
viable candidates which Roche considered but passed up in favor of more promising prospects.
Thus, the public disclosure of Roche’s internal feasibility and early development analysis would
cause severe harm to Roche in the highly competitive pharmaceutical industry. See Jarsch Decl.
¶ 9.
Because Roche would be harmed if the documents which contain its trade secrets
regarding the early development of its products, any documents which contain such information
D. Roche and the Public Could be Harmed by the Public Release of Non-Final,
Non-FDA Approved Information
In addition, many of the Exhibits, including 1, 2, 21, 41, 44, 59, 61, and 62, contain
documentation, data, and conclusions for Mircera. The purpose of FDA approval is to have an
independent third party review of the accuracy and thoroughness of important pharmaceutical
information such as safety, dosing, and effectiveness, before such information is released to the
public. The widespread public release of non-final information that has not yet been approved
by the FDA is counter to this purpose, and could have potentially harmful effects to the public
strictly confidential due to the possible risks of public confusion if the non-final documentation
differs from the finalized, FDA approved documentation. See Viswanadhan Decl. ¶ 10.
Consequently, Roche respectfully requests that the exhibits which contain such information be
filed under seal if they are necessary for the Court’s decision.
8
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 9 of 10
E. Roche, Its Patients, and Its Business Partners Would be Harmed by the
Public Disclosure of The Exhibits
Finally, Roche, its patients, and its partners would be harmed by the public release of
Exhibits 5, 22, and 65, which contain confidential patient and third party information. Roche has
obligations under the federal and state privacy laws to insure the confidentiality of information
relating to individual patients who participate in Roche’s studies. In addition, Roche has certain
business agreements in place which obligate Roche to keep confidential proprietary third party
information that is contained in these exhibits. The disclosure of these exhibits would be
inconsistent with Roche’s obligations to its patients and partners, and thus, Roche respectfully
CONCLUSION
For all the foregoing reasons, Roche respectfully requests that if the Court determines
that some or all of the documents submitted to it for in camera review are necessary for its
decision, then Roche requests that Exhibits 1-11, 14-16, 18-25, 28, 34-38, 41-45, 50-56, 59, 61-
9
Case 1:05-cv-12237-WGY Document 560 Filed 06/28/2007 Page 10 of 10
By its Attorneys,
CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and paper copies will be sent to those indicated as non registered participants on the above date.
10