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AMGEN, INC., Plaintiff, V. F. HOFFMANN–LA ROCHE LTD., Roche Diagnostics Gmbh, and Hoff

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AMGEN, INC., Plaintiff, V. F. HOFFMANN–LA ROCHE LTD., Roche Diagnostics Gmbh, and Hoff 160 581 FEDERAL SUPPLEMENT, 2d SERIES patenting subtle variations of the same AMGEN, INC., Plaintiff, device. 35 U.S.C.A. § 102. v. See publication Words and Phras- es for other judicial constructions F. HOFFMANN–LA ROCHE LTD., and definitions. Roche Diagnostics GmbH, and Hoff- mann–La Roche Inc., Defendants. 2. Patents O120 Civil Action No. 05–12237–WGY. An obviousness double patenting United States District Court, (ODP) inquiry is comprised of two steps: D. Massachusetts. first, as a matter of law, a court construes the claim in the earlier patent and the Oct. 2, 2008. claim in the later patent and determines Background: Patentee brought infringe- the differences, and second, the court de- ment action against competitor alleging termines whether the differences in sub- infringement of patents related to recom- ject matter between the two claims render binant erythropoietin (EPO), a naturally the claims patentably distinct. 35 occurring protein that stimulates the pro- U.S.C.A. § 102. duction of red blood cells. Following jury verdict in favor of patentee, patentee 3. Patents O120 sought entry of injunction to restrain fu- Defendants who seek to invalidate a ture infringement. The District Court en- particular claim via obviousness double tered preliminary injunction. Competitor patenting (ODP) must prove by clear and appealed. While appeal was pending, pat- convincing evidence that the original claim entee sought permanent injunction. and the allegedly duplicative claim are not Holdings: The District Court, William G. patentably distinct. 35 U.S.C.A. § 102. Young, J., held that: (1) patent for EPO production was not 4. Patents O120 invalid as anticipated by prior patent; Where the metes and bounds are dis- (2) patentee’s defense against obviousness cernable from the face of the patent claim, double patenting (ODP) allegations the obviousness double patenting (ODP) were not barred by judicial estoppel; inquiry focuses on what is claimed without (3) competitor was not entitled to new trial reference to the disclosure. 35 U.S.C.A. based on invalidity of patent; § 102. (4) patent was not invalid based on indefi- 5. Patents O120 niteness; There are two ways that a court can (5) jury’s finding that accused product in- conduct the obviousness double patenting fringed patent claim was supported by (ODP) analysis in a patent infringement sufficient evidence; and action; in most cases, courts employ a (6) entry of permanent injunction would ‘‘one-way’’ test where the court compares moot appeal of preliminary injunction. the claims according to the order in which Ordered accordingly. the patents issued. 1. Patents O120 6. Patents O120 ‘‘Obviousness double patenting’’ A later patent claim that is not patent- (ODP) is a judicially devised species of ably distinct from an earlier claim in a obviousness that prevents inventors from commonly owned patent is invalid for obvi- over-extending the term of exclusivity by ous-type double patenting. AMGEN, INC. v. F. HOFFMAN–LA ROCHE LTD. 161 Cite as 581 F.Supp.2d 160 (D.Mass. 2008) 7. Patents O120 not publicly disclosed or available, and as If the scope of the patent application far as ordinarily skilled artisan at the time and the patent claims are not identical, the was concerned, there was no recombinant court must ask whether the later patent’s erythropoietin. 35 U.S.C.A. §§ 102, 121. claim defines merely an obvious variation of the earlier patent’s claim, when conduct- 11. Patents O120 ing an obviousness double patenting (ODP) Obviousness-type double patenting analysis. (ODP) rejections are based on the premise that an applicant is claiming no more than 8. Patents O120 an obvious variation, which would be obvi- The two-way test to determine obvi- ous to anyone of ordinary skill in the art, ousness double patenting (ODP) must be of an invention on which a patent has used if: (1) the patent applicant could not already been granted. have filed both claims together in the earli- er-filed application, and (2) the applicant 12. Patents O120 did not cause the later filed claim to issue When performing obviousness double first by delaying examination of the earli- patenting (ODP) analysis, patent claims er-filed claim during the period when both are looked to only to see what has been applications were pending before the Pat- patented, the subject matter which has ent and Trademark Office (PTO), the ‘‘co- been protected, not for something one may pendency period’’. find to be disclosed by reading them. 9. Patents O120 13. Patents O120 Later filed patent for erythropoietin purification disclosed follow-on invention Patentee was entitled to protection that issued after underlying claims due to under safe harbor provision, and thus restriction order imposed by Patent and claims in patent related to recombinant Trademark Office (PTO) on application, erythropoietin (EPO) were immune from and thus two-way test to determine obvi- obviousness double patenting (ODP) rejec- ousness double patenting (ODP) applied in tion; follow-up patent applications were patentee’s infringement action; it was im- filed as result of Patent and Trademark possible for patentee to have filed claim of Office (PTO) restriction requirement, and later patent as part of application, and patentee complied with restriction require- patentee did not delay examination of ear- ments. 35 U.S.C.A. § 121. lier filed application during co-pendency 14. Patents O120 period or cause later filed patent to issue Claims in a divisional patent applica- before patents in suit. 35 U.S.C.A. tion are only immune from an obviousness- §§ 120, 121. type double patenting (ODP) rejection 10. Patents O120 when strict consonance exists between the Claim in follow-up patent which de- earlier restriction requirement and the scribed specific seven step process for pu- claims later prosecuted. 35 U.S.C.A. rifying recombinant erythropoietin (EPO) § 121. and underlying claims in patent related to recombinant erythropoietin (EPO), were 15. Patents O110 not identical in scope, and thus underlying Consonance requires that the line of patent for EPO production was not invalid demarcation between the independent and for obviousness double patenting (ODP); distinct inventions that prompted the Pat- patent was not prior art, applications were ent and Trademark Office (PTO) restric- 162 581 FEDERAL SUPPLEMENT, 2d SERIES tion requirement be maintained; where produce glycosylated polypeptide having that line is crossed the safe harbor provi- specified characteristics. 35 U.S.C.A. sion does not apply. 35 U.S.C.A. § 121. § 121. 16. Patents O110 21. Patents O120 New or amended claims in a divisional patent application are entitled to the bene- The second step in the obviousness fit of the safe harbor provision if the double patenting (ODP) analysis, after claims do not cross the line of demarcation identifying the differences between the drawn around the invention elected in the claims at issue, is to determine whether restriction requirement. 35 U.S.C.A. those differences in subject matter render § 121. the later-issued claim patentably distinct from the earlier-issued claim. 17. Patents O120 Determining what is patented by cor- 22. Patents O120 rect claim interpretation is essential to the determination of obviousness-type double A later-claimed invention is patent- patenting (ODP) issues. ably distinct, and therefore not invalid for obviousness double patenting (ODP), if 18. Patents O314(5) that invention as a whole would not have It is the Court’s role, not the jury’s, to been obvious over the earlier-claimed in- determine the metes and bounds of the vention to a person of ordinary skill in the claimed inventions in a patent infringe- art at the time just before the later- ment action. claimed invention was made. 19. Patents O120 When a patent claim is not immunized 23. Estoppel O68(2) from allegations of obviousness-type dou- ‘‘Judicial estoppel doctrine’’ prevents a ble-patenting (ODP) due to the safe harbor litigant from pressing a claim that is incon- provision, the question becomes whether sistent with a position taken by that liti- the defendant has met its burden of prov- gant either in a prior legal proceeding or ing the ODP defense; as with other affir- in an earlier phase of the same legal pro- mative defenses of invalidity, the defen- ceeding. dant bears the burden of proving ODP by See publication Words and Phras- clear and convincing evidence. 35 es for other judicial constructions U.S.C.A. § 121. and definitions. 20. Patents O66(1.12) 24. Estoppel O68(2) Patentable differences existed be- tween prior patent for DNA sequences Primary purpose of the doctrine of encoding erythropoietin and patent for judicial estoppel is to safeguard the integ- production of recombinant erythropoietin rity of the courts by preventing parties (EPO), and thus patent for recombinant from manipulating the machinery of the EPO production was not invalid as antici- judicial system. pated by prior patent; claims in prior pat- 25. Estoppel O68(2) ent were directed to purified and isolated DNA sequences and cells into which such Judicial estoppel applies to arguments DNA sequences had been introduced, and positions presented to the Patent and while claims in patent at issue were pro- Trademark Office (PTO) from which the cess claims that recited steps required to patentee gained a benefit. AMGEN, INC. v. F. HOFFMAN–LA ROCHE LTD. 163 Cite as 581 F.Supp.2d 160 (D.Mass. 2008) 26. Estoppel O68(2) 30. Patents O155 Two requirements must be satisfied in Terminal disclaimers are used to over- order to invoke judicial estoppel: first, the come double patenting rejections. 35 prior position must be directly inconsistent U.S.C.A. § 121. with the present position, and second, the responsible party must have succeeded in 31.
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