HELSINN HEALTHCARE S.A. et al v. DR. REDDY'S LABORATORIES, LTD. et al

Filing 382

OUTLINE OF 381 SUPPLEMENTAL OPINION. (Filed per chambers.) (eh, )

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
:
HELSINN HEALTHCARE S.A., et al., :
:
:
Plaintiffs,
:
:
v.
:
:
DR. REDDY’S LABORATORIES
:
LTD., et al.,
:
:
Defendants.
:
:

CIVIL ACTION NO. 11-3962 (MLC)

OUTLINE OF SUPPLEMENTAL OPINION
PRELIMINARY STATEMENT
I.

Findings of Fact
A.
Medical treatment for emesis
B.
The patents-in-suit
C.
Factual chronology
1.
Syntex and the genus ‘333 patent
2.
Roche Syntex further development process
3.
Helsinn license from Roche
4.
The Oread agreements
5.
FDA meeting March 10, 1999
6.
Phase III protocol
7.
Commencement of Phase III trials
8.
The SP agreements
9.
The MGI agreements
10.
Status of Phase III clinical trials on January 30, 2002
11.
Status as of patent application date, January 30, 2003
12.
Issuance of patents-in-suit
13.
Claim construction rulings regarding prosecution history
14.
ANDA filings by Teva and others

1
5
5
9
11
12
16
23
30
33
40
49
51
55
62
73
78
79
81

II.

Conclusions of Law
A.
On-sale bar
1.
Legal standards and post-AIA statutory construction
a.
Historical analysis
b.
Parties’ arguments regarding on-sale bar
c.
Interpreting the legal standard
1.
Statutory construction
2.
Agency guidelines
3.
Legislative history
4.
Public policy considerations
d.
Application of legal standards
1.
Statutory construction
2.
Agency guidelines
3.
Legislative history
4.
Public policy considerations
2.
Findings as to sale or offer to sell pre-AIA
a.
Applicable legal standards
b.
Parties’ arguments
c.
Analysis
3.
Findings as to sale or offer to sell post-AIA
a.
Legal standard
b.
Parties’ arguments
c.
Analysis
4.
Findings on ready for patenting
a.
Legal standards
b.
Applied legal standards
1.
Parties’ arguments
2.
Expert opinions
3.
Analysis
5.
Conclusions as to on-sale bar claims
B.
Written Description
1.
Legal standards
2.
Findings and conclusions on written description
C.
Infringement
1.
Legal standards
2.
Findings and conclusions on infringement
a.
Parties’ arguments

82
82
83
83
86
87
87
89
90
91
92
92
95
96
98
100
101
104
106
109
109
112
115
117
117
121
122
123
141
146
146
146
147
150
150
154
154

D.

b.
Analysis
Defining the Person of Ordinary Skill in the Art
1.
Expert testimony
2.
Analysis

CONCLUSION

158
161
162
163
165