1. The Combined Impact of Prior Art Obviousness and Obviousness-Type Double Patenting on Pharmaceutical Patent Life Cycle Strategies Brian V. Slater ACI 12 th Annual Maximizing Pharmaceutical Patent Life Cycles New York, October 4-5, 2011

2. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 1 Post-KSR CAFC Prior Art Obviousness Decisions 0 1 2 3 4 5 NCEStereoisomersBiomoleculeFormulationMethod of Treatment Type of Patent Opinions Not ObviousObviousRemand

3. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 2 Basics of Obviousness-Type Double Patenting (OTDP)  Judge-made law to prevent an unjustified extension of the patent term.  Prohibits claims in later patent that are not “patentably distinct” from claims in a commonly owned, earlier patent. –Not “patentably distinct” if later claim is obvious over, or anticipated by, earlier claim.  Two-step analysis: 1.Construe claims in patents and determine the differences. 2.Determine whether differences render claims patentably distinct. See, e.g., Pfizer v. Teva, 518 F.3d 1353, 1363 (Fed. Cir. 2008).

4. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 3 Issues  What is the proper use of the specification in an OTDP analysis?  Is a terminal disclaimer filed after expiration of the earlier patent effective?  Are motivation and secondary considerations relevant to an OTDP analysis?  What happens if the only reason one patent expires earlier than another is because of the change in patent terms brought about by the GATT?

5. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 4 1. Use of Specification to Construe Claims of OTDP References  Long-standing precedent: –CAN use specification to construe claims of OTDP reference –CANNOT use OTDP reference specification as if it were prior art  In Pfizer and Geneva, CAFC extended legitimate use of specification: –It is OTDP to later claim use of a compound where that use was disclosed in OTDP reference claiming the compound  But what if the specification of the OTDP reference discloses more than one use of the compound?

6. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 5 Sun v. Eli Lilly, 611 F.3d 1381 (Fed. Cir. 2010) ’883 application ’614 patent Claims to gemcitabine and anti-viral use ’826 patent Claims to anti-cancer use Mar. 10, 1983Issued: Feb. 28, 1989 Adds to spec.: Method of treating cancer using gemcitabine ’146 application Method of treating viral infections using gemcitabine ’783 application Dec. 4, 1984 Issued: Nov. 7, 1995 CIP Method of treating cancer using gemcitabine Filed the same day

7. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 6 Sun v. Eli Lilly, 611 F.3d 1381 (Fed. Cir. 2010)  Held (Prost, J.): ’826 patent is invalid for OTDP –Lilly argued that Pfizer and Geneva cases are distinguishable because the reference patents allegedly disclosed only one use that was essential to patentability.  Court rejected Lilly’s argument, finding OTDP “encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.” Id. at 1386. –Court also rejected Lilly argument that court should consider only the specification of the reference patent as of the effective filing date of the ’614 patent, i.e., that of the ’883 application. Id. at 1387-88.  The “relevant specification for claim construction purposes is that of the issued patent.” Id. at 1388-89.

8. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 7 Sun v. Eli Lilly, 625 F.3d 719 (Fed. Cir. 2010)  CAFC denied petition for rehearing and rehearing en banc.  Judge Newman dissented, joined by Judges Rader, Lourie, and Linn: –The OTDP analysis only compares what is claimed. Id. at 722.  The specification may not be used as prior art. Id.  The specification is “irrelevant to the [] analysis” except to construe the claims. Id. at 721. –Claim to later-discovered use does not provide an improper extension of the patent right to the compound. Id. at 723.  The Supreme Court denied petition for writ of certiorari, 131 S. Ct. 2445 (2011).

9. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 8 Eli Lilly v. Teva, 2011 WL 3236037 (D. Del. July 28, 2011)  Claims in suit were to pemetrexed (Alimta ® ) –Earlier-expiring patent claimed an intermediate compound and exemplified its use –Defendants argued it was obvious to use the intermediate in the earlier patent to arrive at pemetrexed  Held (Sleet, J.): Claims VALID under OTDP analysis –Defendants impermissibly used specification as if it were prior art –Distinguishes Sun  Patent in suit did not claim the use of the intermediate

10. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 9  ’812 claims in suit were to pramipexole (Mirapex ® ) –Boehringer sought to overcome OTDP defense based on then-expired ’086 patent by filing terminal disclaimer against it on last day of trial 2. Terminal Disclaimers: Boehringer Ingelheim v. Barr Labs., 592 F.3d 1340 (Fed. Cir. 2010) ’812 patent ’086 patent ~ 6 monthsPTE (not for all claims) Terminal disclaimer filed PTE (not for all claims) ’812 patent ’086 patent  District Court found ’812 patent invalid for OTDP over ’086 patent

11. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 10 Terminal Disclaimers: Boehringer Ingelheim v. Barr Labs., 592 F.3d 1340 (Fed. Cir. 2010) (cont.)  Held (Linn, J.): Reversed and remanded –Terminal disclaimer is ineffective if filed after earlier patent has expired:  Patentee cannot “undo... unjustified timewise extension” retroactively. Id. at 1348.  Rights during PTE period are different from rights under patent: PTE is “limited to any use then under regulatory review.” PTE did not apply to all claims.  OTDP finding nevertheless reversed because § 121 safe-harbor provision applies to a divisional of a divisional.

12. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 11 3. Motivation and Secondary Considerations  Claims at issue held invalid for OTDP as anticipated by claims of earlier-expiring patents.  Footnote 1 – distinctions between § 103 and OTDP: 1.“The objects of comparison are very different: Obviousness compares claimed subject matter to the prior art; nonstatutory double patenting compares claims in an earlier patent to claims in a later patent or application; 2.Obviousness requires inquiry into a motivation to modify the prior art; nonstatutory double patenting does not; 3.Obviousness requires inquiry into objective criteria suggesting non-obviousness; nonstatutory double patenting does not.” Geneva v. GlaxoSmithKline, 349 F.3d 1373, 1378 (Fed. Cir. 2003)

13. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 12 Ortho-McNeil v. Watson, 2011 WL 254313 (D.N.J. Jan. 25, 2011)  Claims in suit were to a kit and method of using a combination oral contraceptive containing, inter alia, doses of 25 mcg of ethinyl estradiol (EE) (Ortho Tri-Cyclen Lo ® )  Held (Chesler, J.): Denied SJ motion of OTDP over reference having claims to a kit containing EE doses of 20-50 mcg and 35 mcg –Secondary considerations relevant to an OTDP analysis:  “[Geneva footnote] states only that nonstatutory double patenting does not require examination of secondary considerations. This does not mean that such considerations are excluded....” Id. at *6 n.1. –Genuine issues of material fact found:  Evidence in prior art teaching away from lowering the EE dose; and  Unexpected results of claimed regimen. Motivation and Secondary Considerations (cont.)

14. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 13 Eli Lilly v. Teva, 2011 WL 3236037 (D. Del. July 28, 2011)  Held: VALID under OTDP analysis –Secondary considerations are not relevant to OTDP analysis.  But Court did consider motivation to modify intermediate and similar compounds. Cf. Geneva, n.1, subpart 2. Motivation and Secondary Considerations (cont.)

15. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 14 Brigham & Women’s Hospital v. Teva, 761 F. Supp. 2d 210 (D. Del. 2011)  ’068 and ’003 patents claimed genera encompassing cinacalcet (Sensipar ® )  ’244 patent claims cinacalcet compound & salts 4. Effect of GATT on OTDP ’244 patent ’068 patent ’003 patent Reference Patent See also Abbott v. Lupin, 2011 WL 1897322 (D. Del. May 19, 2011) (same; no “improper gamesmanship” by patentee)  Held (Bartle, C.J.): VALID under OTDP analysis –“[T]he ’244 patent’s term could not extend the patent protection to which plaintiffs were already entitled on the ’068 and ’003 patents.” –Later-issued ’244 patent did not create an “unjustified timewise extension.” Filed pre-GATT Filed post-GATT

16. FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | www.fitzpatrickcella.com 15 NEW YORK 1290 Avenue of the Americas New York, NY 10104-3800 212.218.2100 WASHINGTON 975 F Street, NW Washington, DC 20004 202.530.1010 CALIFORNIA 650 Town Center Drive, Suite 1600 Costa Mesa, CA 92626 714.540.8700