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Straightforward Tips:
by Dennis Crouch
Acadia Pharms v. MSN Pharms, 20-cv-00985-GBW (D.Del. December 13, 2023) [SG No OTDP]
I’ve been writing some about obviousness-type double patenting and thought I’d proceed the method with this vital new choice from Choose Williams denying the generic competitor’s movement for abstract judgment of invalidity primarily based upon double patenting, and, the truth is, granting the patentee’s abstract judgment of no invalidity. The case includes an try by generics to start advertising and marketing a generic model of Acadia’s Parkinson’s drug Nuplazid (pimavanserin). This might be an fascinating attraction to look at.
On the abstract judgment stage, the events filed competing abstract judgment motions specializing in whether or not one patent being asserted (US7601740) must be held invalid primarily based upon obviousness-type double patenting (OTDP). It is a ‘patricide’ scenario the place the reference patent (US9566271) was each later filed and later issued. Due to the usual 20-year patent time period calculation, each would ordinarily expire on the identical day. Nevertheless, the due to patent time period adjustment (and PTE), the sooner ‘740 patent truly expires years later.
In its choice, the courtroom supplied two various justifications for siding with the patentee, which I’ll focus on in reverse order:
No Patricide: First, the courtroom held that the ‘271 patent doesn’t qualify as a correct OTDP reference towards the earlier-filed and earlier-issued ‘740 patent. The courtroom famous that it couldn’t discover any case that allowed a later-filed and later issued patent to invalidate an earlier one below OTDP. “The Court docket has been unable to establish a case the place, when challenged, a later-filed, later-issued, earlier-expiring patent was used as an OTDP reference to invalidate an earlier-filed, earlier-issued, later-expiring patent. Right here, the claims within the challenged patent have been earlier-filed and thus are entitled to their full time period, together with the PTA.” The Federal Circuit only recently defined in its Cellect choice that “claims within the challenged patents are entitled to their full time period, together with the duly granted PTA, until they’re discovered to be later-filed apparent variations of earlier-filed, commonly-owned claims.” In re Cellect, No. 2022-1293, 2023 WL 5519761 , at *10 (Fed. Cir. Aug. 28, 2023).
Whereas I recognized this case as “patricide,” I see some drawback with that assertion as a result of each patents declare precedence again to the identical unique efficient submitting date and (I consider that) the claims within the reference patent have been a part of the initially filed utility. Thus, the 2 ought to most likely be seen as concurrently filed slightly than sequentially, although one was formally filed previous to the opposite.
The district courtroom held that as a result of the ‘740 patent was earlier-filed, the ‘271 patent couldn’t function a correct OTDP reference towards it. Because the courtroom concluded, “As a result of a patent should be later-filed to be accessible as an OTDP reference, the Court docket finds that the ‘271 patent doesn’t qualify as a correct reference towards the ‘740 patent.” Permitting the later-filed ‘271 patent to invalidate the ‘740 patent would contradict each precedent and the aim of stopping unjustified patent time period extensions.
I may also word right here that there are a variety of pre-GATT instances that do apply OTDP utilizing later-filed purposes as a reference, however that was a special time when patent time period was measured from the problem date. The Federal Circuit lastly signaled a shift in Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), cert. denied, 135 S. Ct. 1530 (2015) and distinguished the issue-date focus of the basic Supreme Court docket case of Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894). See additionally, Daniel Kazhdan, Obviousness-Kind Double Patenting: Why It Exists and When It Applies, 53 Akron L. Rev. 1017, 1038 (2019) (“Now, nevertheless, solely the expiration date mattered.”).
Later instances have continued to match submitting dates as a part of the OTDP evaluation. Nevertheless, this strategy skips over Choose Chen’s key reasoning in Gilead that targeted on the patent expiration date and whether or not that was being improperly prolonged. Chen wrote “trying to patent problem dates had beforehand served as a dependable stand-in for the date that actually mattered—patent expiration. . . . [T]hat instrument doesn’t essentially work correctly for patents to which the URAA applies, as a result of there at the moment are cases, like right here, through which a patent that points first doesn’t expire first.” Gilead. The nuance right here when utilized to Acadia is that Choose Williams seems to have obtusely targeted on the submitting date whereas ignoring “the date that actually mattered—patent expiration.” In Gilead, the primary issued patent had an extended patent time period as a result of it was later filed and thus was topic to OTDP comparability to a later-issued patent. However the important thing right here for the courtroom was not the submitting date, however slightly the expiration dates — that the patentee had two patents masking apparent variants expiring on completely different dates. That’s the similar scenario the courtroom confronted in Acadia, however Choose Williams was unwilling to maneuver past the formalist submitting date consideration.
Its a Divisional: Choose Williams supplied a second, various reasoning for excluding the asserted reference patent from consideration — holding that the reference patent was protected by the protected harbor of Part 121.
In some instances, the USPTO will problem what is named a “restriction requirement” forcing the patent applicant to divide up a specific utility into separate elements. A typical instance might contain a patent utility claiming a specific chemical compound and a technique of constructing that compound. The examiner will possible see these as two separate innovations and power them to be divided. In that scenario, the patent applicant would possibly preserve the compound claims within the unique utility after which file a “divisional utility” to guard the strategies of manufacture. Part 121 offers a protected harbor for this case such that the 2 family-member patents/purposes can not function references towards each other.
Part 121 is written as a reasonably dense paragraph of textual content, however it seems to have a few vital necessities for the safe-harbor to kick-in:
- The divisional utility should be “filed on account of” the restriction
requirement on one other utility; and - The divisional utility should be “filed earlier than the issuance of the patent on the opposite utility.”
Primarily based upon the peculiar information of this case, MSN argued that neither of those necessities had been met. Ultimately, Choose Williams disagreed and located the divisional protected harbor serves as a second various justification for locating no double patenting.
Acadia filed its utility that led to the ‘740 patent again in 2004 (that is the patent at problem within the case). Three years later, the USPTO issued a restriction requirement and Acadia elected a subset of claims that ultimately issued in October 2009. Not like the continuation purposes that we’ll speak by way of, the ‘740 was delayed on the USPTO and so issued with about 3 years of patent time period adjustment past the strange 20 12 months time period as a part of the patent time period assure supplied by Congress.
In the meantime, one 12 months earlier than the restriction requirement, Acadia had already filed a continuation from the ‘740’s utility (not a divisional). That continuation was pending and prosecution was shifting ahead with a restriction requirement. Relatively taking the everyday response and election within the continuation case, Acadia took a collection of steps: (1) it cancelled the pending claims; (2) offered a brand new set of claims that corresponded to these reserved from the ‘740 restriction; and (3) advised the examiner that it deliberate to vary the case to a divisional. All this occurred in July 2009, just a few months earlier than the unique utility issued in October 2009. It was not till 2010 that Acadia truly amended the specification to formally establish the applying as a divisional six months after the ‘740 patent had already issued. At that time, the patentee filed a collection of continuations from the newly-designated divisional that ultimately resulted within the ‘271 patent — the patent MSI argues correctly serves because the reference for invalidating the sooner issued ‘740 patent.
With this historical past in thoughts, MSI argued that neither of the 2 statutory protected harbor necessities have been met.
- There was no utility filed “on account of a restriction requirement.” Relatively, the applying that turned a divisional was filed previous to the restriction requirement.
- The applying didn’t grow to be a divisional till after the unique utility issued — impermissibly late.
The district courtroom rejected these arguments as misconstruing the statutory necessities. Specifically, it first held that amending an utility to comport with the restriction requirement constitutes “submitting on account of” for the needs of the Part 121 protected harbor. See Union Carbide Corp . v. Dow Chem. Co., 619 F. Supp. 1036 (D. Del. 1985). Additional, the courtroom concluded the actual modification altering the submitting kind to “divisional” was not the important thing requirement. Relatively, the query is was merely whether or not the applying in the end complied with and mirrored the restriction requirement, which the courtroom discovered was happy right here. Right here, it was sufficient that the patentee amended the claims to align with the restricted teams of innovations and informing the examiner of the intent to have the applying be a divisional in compliance with the restriction requirement.
121 protected harbor. Because the district courtroom acknowledged, “an amended utility is one ‘filed on account of such a requirement”‘ when the claims are amended to replicate the restricted teams of innovations. Since Acadia amended the ‘271 patent utility to align with the restriction requirement, the timing of the unique submitting date was irrelevant.
MSN additionally argued that the ‘271 patent utility didn’t successfully grow to be a divisional utility till after the ‘740 patent issued, which was impermissibly late. Nevertheless, the district courtroom discovered this is able to battle with the Federal Circuit’s steering that Part 121 is “not involved with . . . how any such purposes are filed” however slightly simply requires “consonance with the restriction requirement.” The district courtroom decided when the divisional standing was effectuated was not controlling for the protected harbor evaluation. The important thing query was merely whether or not the applying in the end complied with and mirrored the restriction requirement, which the courtroom discovered was happy right here. With these nuances, the district courtroom concluded that Acadia’s convoluted course of happy the 121 necessities and thus that the protected harbor prevents the ‘271 patent from getting used as a OTDP reference towards the ‘740.
= = =
Of some curiosity within the case is that Acadia lately filed what it phrases a “contingent terminal disclaimer” with the USPTO for the ‘740 patent. The terminal disclaimer is contingent on the ‘740 patent claims being discovered invalid for obviousness-type double patenting over the reference ‘271 patent. In different phrases, by its phrases the disclaimer solely takes impact if a last courtroom choice holds the ‘740 claims invalid for obviousness-type double patenting over the ‘271 patent and that call will not be appealed. If that contingency have been to happen, Acadia disclaims the terminal a part of the ‘740 patent time period that may prolong past the expiration date of the complete statutory time period of the ‘271 patent (not together with PTE). As a second double contingency, the submitting states that in a scenario the place the ‘740 is discovered to be double-patenting and in addition the contingent terminal disclaimer is discovered impermissible/void, then the disclaimer robotically converts to a non-contingent terminal disclaimer. [51414_10759561_11-21-2023_DIST]. The USPTO typically doesn’t allow contingent terminal disclaimers to be able to overcome an OTDP rejection. Right here, nevertheless, the patent has already issued and so the TD was merely put within the file wrapper. In my opinion it’s unlikely to be efficient.
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