How We Got Here and a Proposal for Change (Part II)

In Part I of this two-part article, we reviewed the origins of the judicially-created doctrine of obviousness-type double patenting (ODP) and laid out the background on how the U.S. Court docket of Appeals for the Federal Circuit arrived on the 2023 In re Cellect resolution. Right here, we delve deeper into the case legislation and clarify a easy repair for a lot of present-day ODP issues.

In re Gilead

In  Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217 (Fed. Cir. 2014), the query introduced was “[c]an a patent that points after however expires earlier than one other patent qualify as a double patenting reference for that different patent.”  Id., 1211-1212. The courtroom in Gilead concluded “beneath the current circumstances of this case, that it may.”  Id., 1212.

The query in Gilead was framed on this method as a result of courts have been scuffling with apply longstanding double patenting guidelines primarily based on adjustments to patent legislation. Previous to the Uruguay Spherical Agreements Act of 1994 (URAA), patent time period was restricted to 17 years from issuance. For patents filed previous to the URAA (when submarine patents have been frequent and prosecution typically took a few years), situation date was used because the important date for calculating patent time period and thus the important date for ODP—that’s, a later-issued patent with patentably vague claims would essentially have a later expiration date and will subsequently be restricted to the time period of an earlier-issued patent. See, e.g., Novartis Pharms. v. Breckenridge Pharm., 909 F.3d 1355, 1360, (Fed. Cir. 2018) (“Novartis I”) at 1362. After the URAA, the problem date was now not related to calculating patent time period. Patent time period modified from 17 years from situation date to twenty years from the submitting date. Gilead, 1217-1218. That’s, for patents filed after the URAA, the submitting date determines patent time period. The pure corollary is that the submitting date can be the important date for post-URAA ODP evaluation.

In Gilead, nonetheless, the applicant had carried out one thing uncommon. Gilead had filed two patents—the ’375 patent and ’483 patent—each with almost equivalent claims and equivalent specs. The sequence of submitting and issuance is proven under.

As an alternative of submitting the ’483 Patent as a baby of the earlier-filed ’375 patent (as is typical), Gilead filed the ’483 Patent as the primary patent in a brand new household. Gilead at 1210. The 2 patents had completely different examiners and the later-filed ’483 Patent occurred to situation earlier than the earlier-filed ’375 patent. Id., 1210-1211. Nevertheless, as a result of the ’483 patent was filed later and as a part of anew household, its time period prolonged past the time period of the ’375 patent. Based mostly on the sooner situation date of the ’483 patent and current authority governing pre-URAA functions, Gilead argued that the later-issuing ’375 patent couldn’t function the idea for an obviousness-style double patenting rejection for the sooner issuing ’483 patent. Id., 1209.

The bulk in Gilead, nonetheless, was involved that Gilead was exploiting the change within the legislation to improperly lengthen patent time period via a second, later-filed patent  The bulk accurately acknowledged that patent situation date was now not related to patent time period beneath the URAA and held that, on this occasion, the later-issued ’375 patent might function the idea for a double patenting reference towards the ’483 patent. Id., 1211-1212.

The bulk’s evaluation targeted on the expiration date because the important date due to the posture of instances coping with this situation on the time. The defendants in Gilead superior the argument that patent expiration date ought to decide whether or not a patent qualifies as an ODP reference. See Gilead at 1211-1212; Ex Parte Pfizer, No. 6,469,012, 2010 WL 532133, at *15 (B.P.A.I. Feb. 12, 2010) (“at situation is [ ] whether or not patent time period or patent situation date determines if a declare of a patent issued primarily based on a post-GATT utility qualifies as a double patenting reference towards a declare of a patent issued primarily based on a pre-GATT utility.”). Patent homeowners argued (according to the legislation on the time) that situation date was the suitable date. Id. The bulk in Gilead handled the problem as one or the opposite—that’s, in asserting a broad new rule on double patenting, Gilead assumed that situation date or expiration date have been the one two selections. If situation date was not the right date to make use of, then expiration date have to be appropriate. Gilead, 1216-1217.

In actuality, neither date makes a lot sense for post-URAA ODP evaluation. For instance, Gilead cites MPEP §804.I.B.1 for the proposition that “seeking to the expiration date as an alternative of issuance date is according to the PTO’s steerage.”  Gilead, 1216-1217. However MPEP §804.I.B.1 discusses two copending patent functions and “{that a} terminal disclaimer is required for the later of the 2 functions.”  Gilead, 1216-1217. By “later of the 2 functions,” MPEP §804.I.B.1 typically means later filed of the 2 functions. MPEP §804.I.B.1. Gilead merely assumes that the later-filed utility “hypothetical[ly] anticipates to have a later expiration date.”

As one other instance, the patent proprietor in Gilead argued that an emphasis on expiration dates was inconsistent with quite a few prior instances that “describe the double patenting bar as relevant to the ‘second’ or ‘later’ issuing patent.”  Gilead at 1214-1215. Nevertheless, the bulk distinguished these instances as making use of to “patents to which the URAA didn’t apply and, important to a double patenting evaluation, to patents for which the expiration date was inextricably intertwined with the issuance date.” Id. However beneath the URAA, the submitting date is now “inextricably intertwined” with the expiration date. Thus, the submitting date can be the logical date to begin the evaluation. And whether or not pre- or post-URAA, a first-filed, first issued patent can’t be stated to be a “second” or “later” patent just because it has a later expiration date than a subsequent patent.

Additional, Gilead’s evaluation will not be altogether correct. The Software of Robeson resolution mentioned at size in Gilead concerned an ODP rejection throughout prosecution of a second-filed utility over the sooner filed mum or dad patent. Software of Robeson 331 F.2nd 610, 614 (C.C.P.A. 1964)) (“The place the claims of a second utility are considerably the identical as these of the primary patent, they’re barred.. .”). Robson’s logic doesn’t depend upon situation date or expiration date—certainly, no second patent had issued and there was no second expiration date. As an alternative, Robeson is discussing a second filed utility. Equally, Software of Vogel and In re Hubbell each concerned a double patenting rejection of a pending second-filed utility over an earlier-filed utility that had already issued as a patent. Software of Vogel, 422 F.2nd 438, 439 (C.C.P.A. 1970)  In re Hubbell, 709 F.3d 1140, 1142 (Fed. Cir. 2013). Additional, each the second-filed utility and unique, first-filed, patent in Hubbell have been post-URAA. Id.

Choose Rader, in dissent, acknowledged the issues with the bulk’s overemphasis on expiration date. Choose Rader realized that, with the URAA, “the time period of a patent is now typically restricted to twenty years from its submitting date or earliest claimed submitting date” and that, with that change, “successive continuations typically don’t lead to any extra patent time period.”  Id. at 1218. Thus, Choose Rader acknowledged that the URAA had addressed the first goal of the doctrine of obviousness-type double patenting.

Extra importantly, Choose Rader realized that Gilead introduced a “novel state of affairs” and that the courtroom ought to “proceed extra cautiously earlier than articulating a brand new rule.” Id. at 1218. Choose Rader acknowledged that “the ’375 Patent claims precedence to an earlier submitting date and consequently expires first” (Id. at 1218) and “differ[ed] with the courtroom on the impact this courtroom ought to give to subsequent makes an attempt by a patent proprietor to hunt unique rights to apparent variants that do not lengthen the time period of its earlier patent.”  Id. at 1220.

Choose Rader’s instincts for judicial restraint have confirmed prescient. Looking back, to the extent the doctrine of ODP remains to be viable, the important date for post-URAA patents ought to usually be the submitting date—that’s, an earlier filed patent can function the idea for an ODP rejection towards a later filed patent, however not vice versa. That is according to the URAA, which mandates calculating patent time period primarily based on submitting date slightly than situation date. Such a rule would have resulted within the majority in Gilead reaching the very same conclusion, because the ’375 patent was filed 10 months earlier than the ’483 patent, but would even have been according to authority corresponding to Robeson that apply the rule to the second patent.

Novartis I and II Carve Out Exceptions to Gilead 

Adopting the rule that earlier-filed patents ought to function the idea for ODP rejections would even have reached the identical consequence within the subsequent Novartis selections. This might have obviated the necessity to carve out exceptions to the rule introduced in Gilead.

In Novartis I, a primary patent (the ’772 patent) was filed previous to the URAA and its time period was subsequently 17 years from situation. Id. at 1359-1360. A second patent (the ’990 patent) was filed after the URAA went into impact. The ’990 patent’s time period was subsequently 20 years from its efficient submitting date, however the ’990 patent was a divisional of the ’772 patent and subsequently shared the identical efficient submitting date. As a result of the ’772 patent took roughly three and a half years to situation, it expired roughly six months after the later-filed ’990 patent. The courtroom discovered that Novartis I was distinguishable from Gilead as a result of the ’772 patent was a pre-URAA patent and “a change in patent time period legislation shouldn’t truncate the” statutory patent time period. Id., 1358. Thus, the courtroom realized a blanket utility of Gilead would lead to an inequitable consequence (i.e., shortening the statutory time period of a prior-filed patent) and carved out an exception.

In Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018) (“Novartis II”)the courtroom equally acknowledged {that a} blanket utility of Gilead would lead to an inequitable consequence and carved out an exception for extra patent time period granted to earlier-filed patents as a part of the Patent Time period Extension (“PTE”) provisions of the Hatch-Waxman Act. Id., 1372. Beneath the Hatch-Waxman Act, a patent proprietor could use PTE to increase patent time period of a single patent masking a product by as much as 5 years, offered it meets sure different conditions. Novartis selected to use PTE to the ’229 Patent, filed October 18, 1993. The ensuing time period extension meant an expiration date of February 18, 2019, which was roughly a yr and a half after the expiration of the ’565 Patent, which was filed on September 23, 1997 and expired on September 23, 2017. In doing so, the courtroom famous that conventional coverage issues for ODP weren’t current as a result of “it’s the earlier-filed, earlier-issued ‘229 patent, not the later-filed, later-issued ‘565 patent, that has the later expiration date.”  Id., 1374. Thus, Novartis II seems partly to base its reasoning on the sooner submitting of the ’229 patent.

In re Cellect

Quick ahead to In re Cellect, 81 F.4^th 1216 (Fed. Cir. 2023). In Cellect, the Federal Circuit discovered that statutorily granted PTA in a first-filed, first-issued patent may be retroactively revoked or restricted because of an ODP rejection primarily based on a later-filed, later-issued patent. Cellect at 1231. Certainly, Cellect seems to  penalize patent homeowners for submitting continuations with out concurrently and retroactively submitting terminal disclaimers for all different patents within the household.

Cellect’s preliminary error, nonetheless, is its full reliance on patent expiration date because the important date for figuring out ODP. As mentioned above, expiration date is a comparatively arbitrary date picked within the Gilead case with out important clarification or dialogue. The URAA didn’t substitute situation dates with expiration dates for figuring out patent time period; it changed situation dates with submitting dates. Additional, the evaluation in Gilead was cautious to cabin its reliance on expiration date to the details of that case, stating “[w]e subsequently maintain that an earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent beneath the circumstances right here.”  Gilead, 1217. In fact, the circumstances in Gilead have been that the sooner expiring patent was additionally filed earlier. And whereas Novartis I and II framed their discussions with respect to the expiration date, each held that ODP primarily based on the earliest expiration date of the patents at situation was inappropriate given the precise circumstances of these instances.

Cellect expands on Gilead and Novartis I and II, holding that “ODP for a patent [ ] ought to be utilized primarily based on the expiration date [of the earliest expiring patent].”  Id., 1227 (emphasis added). Thus, Cellect  replaces Gilead’s limiting “can … beneath the circumstances right here” language with “ought to.”  Equally, whereas Gilead was cautious to say the earlier-expiring patent additionally had an earlier submitting date, that distinction is misplaced in Cellect.

Had Cellect used the earliest submitting date to find out which patents might kind the idea for ODP double patenting, its consequence would have been according to Gilead and Novartis I and II. In Cellect, the courtroom used the latest-filed patent in a household (the ’036 Patent) to invalidate 4 earlier filed patents. The household relationship is proven under (be aware the date within the field on the decrease proper exhibiting expiration with out PTA needs to be Oct. 6, 2017 slightly than Oct. 6, 1997):

To elucidate why PTA needs to be handled otherwise than PTE, the courtroom went via a prolonged dialogue making an attempt to harmonize statutes and caselaw which have wildly completely different outcomes. Cellect, 1223-1230. Had the evaluation merely used the earliest submitting date (July, 10, 2000, for the ’626 Patent) as the idea for the ODP rejections, the evaluation (making use of Cellect’s conclusion that ODP applies to PTA) would have been easy:  The ’626 patent (filed July 10, 2000) is entitled to 59 days of PTA and all later-filed patents topic to ODP rejections can be restricted to not more than 59 days of PTA. This might repair the problem in Cellect of retroactively eradicating duly-granted PTA primarily based on the truth that a later-filed and later-issued patent occurs to not have PTA.

Implications

The Cellect resolution has already resulted in inconsistent district courtroom outcomes. For instance, in Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd., No. CV 19-1727-RGA, 2023 WL 6295496, at *22 (D. Del. Sept. 27, 2023), Choose Andrews held that “[t]he ‘first-filed, first-issued’ distinction is immaterial. When analyzing ODP, a courtroom compares patent expiration dates, slightly than submitting or issuance dates.”  Conversely, in Acadia Pharamceuticals Inc. v. Aurobindo Pharma Ltd., No. CV 20-985-GBW, 2023 WL 8803448, at *7 (D. Del. Dec. 13, 2023), Choose Williams got here to the other conclusion, holding “if a later-filed patent is used as a reference, the logic and function of OTDP is flipped on its head: slightly than stopping a patent proprietor from unjustifiably extending the time period of a patent, OTDP would function to chop off a patent time period that will have been legitimate however for a later-filed patent.”

Choose Andrews’ opinion might be the one that’s most trustworthy to Cellect. There is no such thing as a express carveout in Cellect for earlier filed patents. Nevertheless, Choose William accurately identifies the logical and equitable points attributable to ignoring the submitting dates in favor of a blanket rule that solely expiration dates matter. Each instances are on attraction and will probably be attention-grabbing to see how the Federal Circuit handles the opinions given the quite a few points commentators have raised with Cellect.

The legislation on ODP after Cellect is unpredictable and retroactively penalizes patent homeowners who’ve prosecuted youngster functions in good religion. A doctrine that was initially meant to stop patent homeowners from growing their statutorily granted patent time period via gamesmanship has morphed right into a doctrine that incentivizes gamesmanship by defendants to file reexaminations on expiring patents. ODP is a judicially-created doctrine that doesn’t match neatly into the present patent statute and arguably needs to be eradicated altogether slightly than strengthened. To the extent the doctrine will not be eradicated, the Federal Circuit ought to depend on submitting dates slightly than expiration dates for ODP rejections going ahead.

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