AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd.

703 F.3d 511, 105 U.S.P.Q. 2d (BNA) 1437, 2012 U.S. App. LEXIS 25694
CourtCourt of Appeals for the Federal Circuit
DecidedDecember 14, 2012
Docket2010-1460, 2010-1461, 2010-1462, 2010-1463, 2010-1464, 2010-1465, 2010-1466, 2010-1467, 2010-1468, 2010-1469, 2010-1470, 2010-1471, 2010-1472, 2010-1473
StatusPublished
Cited by56 cases

This text of 703 F.3d 511 (AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd., 703 F.3d 511, 105 U.S.P.Q. 2d (BNA) 1437, 2012 U.S. App. LEXIS 25694 (Fed. Cir. 2012).

Opinions

Opinion of the court filed by Circuit Judge NEWMAN. Concurring opinion filed by Circuit Judge PLAGER.

Dissenting opinion filed by Circuit Judge MAYER.

NEWMAN, Circuit Judge.

This patent litigation arises under the Hatch-Waxman Act, 21 U.S.C. § 355, whereby producers of generic pharmaceutical products are authorized to challenge the patent status of a federally registered and approved drug product, before the generic producer has obtained approval to sell its counterpart of the approved product. The generic litigant who succeeds in eliminating the drug patent is granted a 180-day period of exclusivity against other potential providers of the generic product. 21 U.S.C. § 355(j)(5)(B)(iv).

The drug product here at issue is the “statin” having the brand name Crestor®, which is federally approved for use in control of cholesterol and for treatment of atherosclerosis. In suit is United States Reissue Patent No. 37,314 (“the '314 patent”), which is a reissue of United States [515]*515Patent No. 5,260,440 (“the '440 patent”). The patentee is Shionogi Seiyaku Kabush-iki Kaisha (“Shionogi”) and the exclusive licensee is AstraZeneca UK and its United States subsidiary IPR Pharmaceuticals Inc. (collectively “Plaintiffs”).

The active ingredient of Crestor® is the calcium salt of a chemical compound whose common name is rosuvastatin, of the following structural formula:

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Rosuvastatin is one of several statin products that lower cholesterol production in the liver by inhibiting the enzyme HMG-CoA reductase. Scientists working at the Shionogi laboratory in Japan were conducting research in search of a statin with reduced side effects as compared with the statin products that were then known. In the course of this research, in 1991 they discovered rosuvastatin and its beneficial properties. Patents were obtained in Japan and other countries, including the '314 patent in the United States.

Federal approval for sale and use in the United States was granted on August 12, 2003, after over two decades of development. The product was highly successful, due to its superior efficacy in lowering low-density (LDL) cholesterol and elevating high-density (HDL) cholesterol, and its reduced side effects, as compared with other commercial statins. See Peter H. Jones et ah, Comparison of the Efficacy and Safety of Rosuvastatin Versus Atorvastatin, Sim-vastatin, and Pravastatin Across Doses (STELLAR Trial), 92 Am. J. Cardiology 152 (2003).

Several generic producers initiated a challenge to the '314 patent by filing an Abbreviated New Drug Application (ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. § 355(j)(2)(A)(vii)(IV). An ANDA permits a generic producer to market a drug product based on the federal approval obtained by the original registrant. Submission of an ANDA constitutes a statutory act of infringement pursuant to § 271(e)(2) of the Patent Act, which provides:

It shall be an act of infringement to submit an application under [section 355(j) of title 21] ... for a drug claimed in a patent or the use of which is claimed in a patent ... if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

35 U.S.C. § 271(e)(2)(A). If the challenge to the patent fails, the ANDA cannot be approved until expiration of the patent. 35 U.S.C. § 271(e)(4)(A).

The infringement suits against the several generic challengers were consolidated in the United States District Court for the District of Delaware. The Defendants are Aurobindo Pharma Ltd., Mylan Pharmaceuticals Inc., Apotex Corp., Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Sun Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Par Pharmaceuticals, Inc., and Sandoz, Inc. The Defendants argued that the '314 pat[516]*516ent is invalid on the ground of obviousness and improper reissue, and that the patent is unenforceable for inequitable conduct in the Patent and Trademark Office (“PTO”).

The district court ruled that the '314 patent is valid, enforceable, and infringed.1 The Defendants all admitted infringement, except for Apotex Corp. All of the Defendants appeal the rulings of validity and enforceability.

I

Validity

The Defendants challenge patent validity on the ground of obviousness. Obviousness is decided as a matter of law based on four basic factual inquiries, as set forth in Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966), and elaborated in KSR International, Co. v. Teleflex Inc., 550 U.S. 398, 406-07, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007), viz., (1) the scope and content of the prior art, (2) the level of ordinary skill in the field of the invention, (3) the differences between the claimed subject matter and the prior art, and (4) any objective indicia of unobviousness, such as commercial success or long-felt need, or failure of others.

The Defendants identified as the closest prior art European Patent Office Publication No. 0 367 895 of the Sandoz company (“Sandoz ”), published May 16,1990, which describes numerous pyrimidine-based sta-tin compounds, including a compound designated as Compound lb. Compound lb has two -CH3 (methyl) groups on the amino side chain, instead of one -CH3 and one -S02CH3 group as in rosuvastatin. Compound lb has the following structural formula:

The Sandoz European application describes Compound lb as an “especially preferred embodiment of the invention.” Sandoz, at *9. The Defendants argued in the district court that this statement suggests that Compound lb would be a good “lead compound” for further research, and that with this selection as lead compound the change of the -CH3 group to a -S02 CH3 group would have been obvious because it would make Compound lb more hydrophilic. The Defendants stated that

F.Supp.2d 388 (D.Del.2010). [517]*517numerous publications taught that liver-selective statins may have fewer undesirable side effects, and that hydrophilic sta-tins are more liver-selective. The Defendants argued that persons of ordinary skill in this field would have been motivated to make Sandoz Compound lb more hydro-philic, and that the C2 position (as marked on the molecule supra) was the logical place to modify Compound lb because the other parts of the structure were known to be essential to statin activity. The Defendants argued that a person of ordinary skill would have considered a limited number of common substitutions, including a sulfonyl “spacer” -S02 — at the C2 position to increase hydrophilicity.

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Bluebook (online)
703 F.3d 511, 105 U.S.P.Q. 2d (BNA) 1437, 2012 U.S. App. LEXIS 25694, Counsel Stack Legal Research, https://law.counselstack.com/opinion/astrazeneca-uk-ltd-v-aurobindo-pharma-ltd-cafc-2012.