1. Obviousness-type Double Patenting
AIPLA
July 20, 2017
© 2017 Sheridan Ross

2. Obviousness-type Double Patenting (ODP)
Judicially developed basis for rejecting claims that are not patentably distinct from claims of another patent
Purpose: To prevent “unjustified or improper” extension of patent rights beyond the statutory term of the patent
Distinct from statutory double patenting

3. Patentably Distinct
A claim is not patentably distinct if it is obvious in light of an earlier claim
Similar to § 103 obviousness analysis but limited to comparison of claims

4. Limited Use of Specification in ODP Analysis
Only the claims of an earlier patent should be examined to determine an ODP rejection, unless
(1) The disclosure is necessary to understand the scope of the earlier claims, or
(2) The later application claims a use for a composition that was disclosed but not claimed in the earlier patent
Eli Lilly v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2012)

5. Overcoming an ODP rejection
File a Terminal disclaimer
Same expiration date
Common ownership
Argue claims are patentably distinct

6. One-way & Two-way Test for ODP
One-way test
Is A obvious in light of B?
Yes, then ODP can apply
Two-way test
Is A obvious in light of B AND Is B obvious in light of A?
Yes to both, then ODP can apply
Applies when the applicant could not have filed the claims in a single application and the PTO is the cause of a delay that results in a later-filed patent issuing before the earlier-filed patent
In re Hubbell (Fed. Cir. 2013)

7. §121 Safe harbor
“A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.” 

8. Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cr. 2014)
Changed framework of ODP analysis
Old rule: earlier issuing patents can be reference patents in ODP rejections but not vice versa
New rule: later issuing but earlier expiring patents can be reference patents for ODP rejections
Date of issuance no longer the key factor

9. Gilead Sciences, Inc. v. Natco Pharma Ltd.
Cut Off Point

10. Gilead Sciences, Inc. v. Natco Pharma Ltd.
Gilead reasoning:
“The expiration of the ’375 patent triggers the public’s right to use the invention claimed in it and all obvious modifications of that invention.”

11. AbbVie Inc. v. Kennedy Inst. of Rheumatology (Fed. Cir. 2014)
Cut Off Point

12. AbbVie Inc. v. Kennedy Inst. of Rheumatology
Applied Gilead to two patents in the same family claiming different priority dates and hence, different expiration dates

13. Magna Elecs., Inc. v. TRW Auto. Holdings Corp. (W.D. Mich., 2015)
Cut Off Point
ODP used to override a grant of PTA

14. Magna Elecs., Inc. v. TRW Auto. Holdings Corp.
Applied Gilead to two patents in the same family with same priority dates and same 20-year expiration dates to erase PTA award

15. Janssen Biotech, Inc. v. Celltrion Healthcare Co. Inc. (D. Mass
Cut Off Point

16. Janssen Biotech, Inc. v. Celltrion Healthcare Co. Inc.
Applied Gilead to two patents in the same family with same priority dates but different expiration dates because one was filed pre-GATT

17. Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc. (D. Del. 2016)
Cut Off Point
Terminal disclaimer required because application was abandoned for some time

18. Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.
Did not apply Gilead to a case where both patents were pre-GATT and expiration date was a direct function of issue date
“The patents-at-issue are from the same family, indeed the 781 patent is a continuation of the '353 patent. The patents were examined by the same examiner at the PTO. Under the particular circumstances, the oddity of using the 781 patent as a reference patent to cut short the '353 patent's (the first issued parent patent) term of exclusivity is rejected. This is not an instance of a patentee seeking to extend the patent term with "sequential" applications.”

19. Novartis Pharm. Corp. v. Breckenridge Pharm., Inc. (D. Del., 2017)
Cut Off Point

20. Novartis Pharm. Corp. v. Breckenridge Pharm., Inc.
Applied Gilead to two patents in the same family with same priority dates but different expiration dates because one was filed pre-GATT
PTE under Hatch-Waxman Act may be applied to a patent subject to a terminal disclaimer.
Merck & Co. v. Hi-Tech Pharmacal ( ) (March 2007)

21. Remedies/Prosecution Strategies
Review existing portfolios
Limit prosecution one patent per invention type (or independent species)
Encourage restriction requirements to maintain §121 “safe harbor” rights
Prosecute narrow claims first
Argue against ODP rejections by distinguishing claimed inventions
Monitor PTA accrual
Does judicial doctrine trump statutory grant of PTA?

22. References Cited
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 689 F.3d 1368 (Fed. Cir. 2012).
In re Hubbell, 709 F.3d 1140 (Fed. Cir. 2013).
Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014).
Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014).
Magna Elecs., Inc. v. TRW Auto. Holdings Corp., No. 1:12-CV-654, 2015 WL (W.D. Mich. Apr. 28, 2015).
Janssen Biotech, Inc. v. Celltrion Healthcare Co. Inc., No MLW, 2016 WL (D. Mass. Aug. 19, 2016).
Merck Sharp & Dohme Corp. v. Teva Pharm. USA, Inc., 217 F. Supp. 3d 782 (D. Del. 2016).
Merck & Co. v. Hi-Tech Pharmacal ( ) (March 2007)
Novartis Pharm. Corp. v. Breckenridge Pharm., Inc., No. 1:14-CV-1043-RGA, 2017 WL (D. Del. Apr. 3, 2017).

23. Thank you for your attention! Questions?