Obviousness-Type Double Patenting Considerations

Obviousness-type double patenting (“ODP”) is a judicially created doctrine aimed at preventing patent owners from extending patent protection beyond the statutorily afforded term.  Prior to the Uruguay Round Agreements Act (“URAA”) of 1994, which changed the term for a U.S. patent from seventeen years from patent issuance to twenty years from the earliest (non-provisional) filing date, patent applicants could theoretically extend their patent term without end.  For example, a series of patent applications covering the same or similar subject matter, with slightly different claims could be filed.  Further, applicants could try to intentionally delay prosecution and, thus, stagger issuance of the resulting patents.

After the switch to a twenty year term from the earliest (non-provisional) filing date by the URAA, it has been advocated that the ODP doctrine is now moot and should be eliminated, because applicants can no longer serially extend patent term.  However, the Federal Circuit’s decisions in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), and Abbvie v. Mathilda & Terence Kennedy Institute, 764 F. 3d 1366 (Fed. Cir. 2014), have reaffirmed the ODP doctrine.  A timeline of the salient facts of Gilead is shown below:

In Gilead, the ‘375 and ‘483 patents named the same inventors, were commonly owned and were directed to similar inventions.  A terminal disclaimer was filed only in the ‘375 patent to disclaim any patent term of the (second to issue) ‘375 patent extending beyond the expiration date of the (first to issue)‘483 patent.  At trial, the patent owner tried to argue that the ‘375 patent should not be available as an invalidating ODP reference against the ‘483 patent because the ‘375 patent issued first and “in no way extends the term of the exclusivity for the ‘483 patent.”  In response, the Federal Circuit explained:

[F]or double patenting inquiries, looking to patent issue dates had previously served as a reliable stand-in for the date that really mattered—patent expiration. But as this case illustrates, that tool does not necessarily work properly for patents to which the URAA applies, because there are now instances, like here, in which a patent that issues first does not expire first. Therefore, in light of the principles reflected in our prior case law as explained above, it is the comparison of Gilead’s patent expiration dates that should control, not merely the issuance dates.

The Federal Circuit thus held that the later issued but earlier expiring ‘375 patent qualified as an invalidating ODP reference and invalidated the earlier issued but later expiring ‘483 patent.  The Federal Circuit repeatedly stated, however, that the expiration date should be seen as the relevant date “under the circumstances of this case,” potentially signaling that its holding may be limited to the specific facts at hand.  Accordingly, whether the Federal Circuit was applying a bright-line rule that the expiration date is the only relevant date to be used for determining if a patent qualifies as an invalidating ODP reference or whether the Federal Circuit was weighing or considering other factors or policy concerns in making its decision is unclear.

The Federal Circuit again addressed the ODP doctrine in Abbvie, which had a similar timeline to Gilead, with the exception that the potentially invalidating patent (Patent A) both issued and expired first, as shown below:

In Abbvie, the patent owner tried to argue that the ODP doctrine should be discarded in light of the URAA, because the statutory and policy rationales underlying the ODP doctrine no longer exist.  The Federal Circuit, however, did not find this argument persuasive.  Instead, it restated the continued importance of the ODP doctrine and reaffirmed Gilead stating:

We now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates.

Again, the Federal Circuit did not provide an explicit indication of whether Abbvie and Gilead established a bright-line rule or should be limited to their specific facts.

After Gilead and Abbvie, the determination for whether a patent qualifies under the ODP doctrine to invalidate another patent remains unclear.  Several recent lower court decisions have interpreted Gilead and Abbvie in different ways, while some courts have looked beyond the expiration dates of the patents in question to determine if a reference qualifies as an invalidating ODP reference, others appear to treat the holding in Gilead as a bright-line rule, with the expiration dates of the patents in question controlling regardless of other factors.  Several recent lower court decisions applying Gilead and Abbvie include:

• Koninklijke Philips N.V. v. Zoll Med. , No. CIV.A. 10-11041, 2014 U.S. Dist. LEXIS 2015 U.S. Dist. LEXIS 182044 (D. Mass. June 20, 2014).
• Magna Electronics, Inc. v. TRW Auto. Holdings Corp., 2015 U.S. Dist. LEXIS 182044 (W.D. Mich. Dec. 10, 2015).
• Janssen Biotech, Inc. v. Celltrion Healthcare Co., Inc., 2016 U.S. Dist. LEXIS 111070 (D. Mass. Aug. 19, 2016).
• Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., 2016 U.S. Dist. LEXIS 158514 (D. Del. Nov. 16, 2016).

The facts of Merck Sharp are shown below:

In Merck Sharp, the patent owner filed a terminal disclaimer in Patent B’, which is a continuation application of Patent A’, such that the expiration date of Patent B’ did not extend beyond that of another application (not shown above) owned by the patent owner, thereby shifting the expiration date of Patent B’ prior to the expiration date of Patent A’.  Based on Gilead and Abbvie, the infringing party attempted to argue that Patent B’ should qualify as an ODP reference against its parent (Patent A’), because the expiration date of Patent B’ preceded that of Patent A’.  But, the Merck Sharp court did not view Gilead or Abbvie as requiring the application of a bright-line rule, and instead looked to whether the patent owner was affirmatively seeking to extend patent term.  Since the patent owner was actually reducing the term of the continuation application (Patent B’), the Merck Sharp court explained that the patent owner could not be attempting to affirmatively extend patent term, and thus held that Patent B’ did not qualify as an invalidating ODP reference against Patent A’.

In Magna Electronics, a later filed patent (Patent B’’) was found to qualify as an invalidating ODP reference to an earlier filed patent (Patent A’’) claiming priority to the same parent application, when the earlier filed patent (Patent A’’) was granted a period of patent term adjustment (“PTA”) shifting its expiration date beyond that of the later filed patent (Patent B’’) as shown below:

The Magna Electronics court did not look to factors or policy concerns, such as whether the patent owner was taking affirmative action to extend the patent term, and instead found that Patent B’’ qualified as an ODP reference simply because Patent B’’ expired prior to Patent A’’.

Therefore, it remains difficult to predict whether a court is going to consider that the patent owner is trying to extend patent term or whether a court will look only to the expiration dates of the patents in question.  Patent owners are cautioned to review patent portfolios with these issues in mind.