Abbott Labs. v. Lupin Ltd., C.A. No. 09-152-JJF-LPS (D. Del. June 18, 2010) (Stark, M.J.).

THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE

ABBOTT LABORATORIES andABBOTT RESPIRATORY LLC,Plaintiffs,

v.

LUPIN LIMITED and LUPINPHARMACEUTICALS, INC.,Defendants.Civ. No. 09-1 52-JJF-LPS

REPORT AND RECOMMENDATIONREGARDING CLAIM CONSTRUCTION

Plaintiffs Abbott Laboratories and Abbott Respiratory LLC (collectively, "Abbott") filedthis patent infringement action against Defendants Lupin Limited and Lupin Pharmaceuticals,Inc. (collectively, "Lupin") on March

6,

2009. (D.l.

1)

Abbott alleges that Lupin infringes seven

of

its patents relating to Abbott's drug Niaspan®: U.S. Patent No. 6,080,428 (the

'''428

patent"),1U.S. Patent

No.6,

129,930 (the

"'930

patent"),2 U.S. Patent No. 7,011,848 (the

"'848

patent"),3U.S. Patent No. 6,406,715 (the

"'715

patent"),4 U.S. Patent No. 6,818,229 (the

'''229

patent"),5U.S. Patent No. 6,676,967 (the

"'967

patent"),6 and U.S. Patent No. 6,746,691 (the '''691

ID.I.

62 is the parties' Joint Appendix. The '428 patent is found at

JAOOOOOl-11.2

of

theJoint Appendix. All subsequent citations to documents stamped

"JA_"

are references to theJoint Appendix.

2The

'930 patent is found at D.l. 62, JA000012-28.

3The

'848 patent is found at

D.1.

62, JA000130-140.1.

4The

'715 patent is found at

D.1.

62, JA000029-49.4.

5The

'229 patent

is

found at

D.1.

62, JA000130-129.03.

6The

'967 patent is found at D.l. 62, JA000050-75.02.

Case 1:09-cv-00152-JJF-LPS Document 95 Filed 06/18/10 Page 1 of 70

patent")? (collectively, the "Abbott patents"). The patents-in-suit are all part

of

the same familyand all relate to compositions for and methods oftreating hyperlipidemia.

(D.1.

54 at

1;

D.1.

55

at 3) Each

of

the Abbott patents refers to initial application 08/124,392, filed in 1993.

(D.1.

54 at2) That application was abandoned, but the continuation-in-part application

08/368,378,

filed in1995, issued in June 2000 as the '428 patent.

(Id.)

The '930 patent is a continuation-in-partfrom the '428 patent.

(ld.)

The '229, '691, '715, and '967 patents are all continuations-in-partfrom the '930 patent, and the '848 patent is a continuation from the '930 patent.

(Id.)

In thisReport

&

Recommendation, I provide my recommendations as to the proper construction

of

thedisputed claim terms in each

of

the Abbott patents.

BACKGROUND

A. Procedural Background

Claim construction issues in this case were referred to the undersigned magistrate judgeper the Court's order

of

February 4, 2010.

(D.1.

51) Briefing was completed in March 2010

(D.1.

54;

D.1.

55;

D.1.

58;

D.1.

60) and a

Markman

hearing was held on May 21, 2010.

See

Transcript

of

May 21, 2010 hearing

(D.1.

94) (hereinafter "Tr.").

B. Hyperlipidemia

Hyperlipidemia "is characterized by the presence

of

excess fats such as cholesterol andtriglycerides in the blood stream," and is associated with abnormally high levels

of

"badcholesterol," which includes high levels

of

low density lipoproteins ("LDL"), triglycerides, andapolipoprotein(a) ("Lp(a)").

(D.1.

55

at 3) Abnormally low levels

of

"good cholesterol," also

?The

'691 patent is found at

D.1.

62, JA000076-102.

2

Case 1:09-cv-00152-JJF-LPS Document 95 Filed 06/18/10 Page 2 of 70

known as high density lipoproteins ("HDL"), are also associated with hyperlipidemia.

(Jd.)

Hyperlipidemia can lead to an increased risk

of

atherosclerosis, which is a hardening

of

thearteries due to an accumulation

of

cholesterol plaque in the arterial walls.

(Id.

at 3-4)Atherosclerosis may cause a number

of

significant health problems, such as coronary heartdisease (that often leads to heart attacks), peripheral arterial disease, and strokes.

(Id.

at 4)

C.

Prior Art Treatments for Hyperlipidemia

Niacin, or "nicotinic acid," has long been used to reduce total cholesterol, LDLs,triglycerides, and LP(a), while increasing HOLs.

(!d.)

Niacin administered to treat theseconditions, however, is accompanied by uncomfortable and dangerous side effects.

(Jd.)

Thetype

of

niacin treatment determines its effects and side effects; generally, niacin is given topatients in either immediate release

or

sustained release dosage forms. (D.L 54 at 2-3)"Immediate release" ("IR") niacin treatments are typically administered three or fourtimes per day, and release nearly all

of

their niacin in the bloodstream very quickly (e.g., within30 to 60 minutes

of

ingestion). (D.L

55

at 4) While

IR

niacin treatments were generally knownto reduce unfavorable cholesterol and increase desirable cholesterol, they were also commonlyassociated with "flushing," a side effect that causes a patient to develop a visibly red,uncomfortable, tingly and/or hot feeling for about one hour after each niacin dose.

(ld.;

D.1.

54 at3) For some, these effects are severe enough to stop taking the drug.

(0.1.

55

at 4) "As a result,physicians have been reluctant to recommend

IR

niacin (and patients have been reluctant to takeit), despite its beneficial lipid-altering effects."

(Id.)

"Sustained release" ("SR") niacin was developed to avoid the flushing side effect thataccompanies

IR

niacin.