Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024)

In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be used for an obviousness-type double patenting (ODP) rejection for another of the applicant’s patent applications. Ultimately, the Federal Circuit held that a first-filed, first-issued, later-expiring claim cannot be invalidated under ODP by a later-filed, later-issued, but earlier-expiring patent with a shared priority date.  Here, the Federal Circuit reversed the District Court’s holding  that claim 40 of plaintiffs-appellant Allergan’s US Patent 7,741,356 was invalid under ODP, and that four other of Allergan’s patents were invalid for lack of written description.

The patents at issue cover the drug Viberzi®, used for treating irritable bowel syndrome, and marketed and sold by Allergan.  Defendants-appellees Sun contended that the claims of the ’356 patent covering the drug were invalid or would not be infringed by Sun’s generic product when Sun submitted an Abbreviated New Drug Application (ANDA) for a generic version of the drug.  Allergan sued Sun for infringing a claim of the ’356 patent and, eventually added complaints for Sun’s infringement of claims of other Allergan patents.

The ’356 patent was the first-filed application in the patent family.  This patent received 467 days of Patent Term Adjustment (PTA) and a number of continuation and divisional applications were filed from this patent, including the other relevant patents in this case.  The notable children applications of this patent did not receive any PTA and thus expire earlier than the first-filed application.

At the District Court, Sun argued that claim 40 of the ’356 patent was invalid for ODP due to the later-filed, but earlier-expiring, patents sharing the same priority date.  Allergan argued that the later-filed patents could not serve as the basis of an ODP rejection even if they did expire earlier.  The District Court had agreed with Sun, finding that the later-filed patents could serve as the basis of an ODP rejection because In re Cellect, LLC, 81 F.4^th 1216 (Fed. Cir. 2023) held that consideration of the expiration dates, not the filing dates, was the basis for an ODP rejection.

The Federal Circuit disagreed with the District Court’s interpretation of Cellect, noting that to interpret the case in the way Sun argues goes against the principals of the ODP doctrine and the Congressional intent backing the purpose of PTA.  Specifically, ODP is to prevent patentees from holding a second patent on a patentably indistinct invention to unjustly extend the term of a first patent.  Since the ’356 patent was undeniably the first patent in the family, the Federal Circuit did not find it logical that the later-filed patents could be used to invalidate the first ’356 patent under ODP.  Further, the Congressional intent of PTA is to provide patentees extra patent term for prosecution delays caused by the USPTO.  As noted in the opinion, prosecution delays can be common for inventions that are first of their kind.  Therefore, to require patent owners to disclaim any PTA, in order to prevent second-filed related patents from invalidating the first-filed patent under ODP, would abrogate the purpose of a PTA.

The Federal Circuit also highlighted nuances of Cellect in that Cellect establishes that the ODP analysis for patents that have received PTA must be based on the expiration date of the patent after a PTA has been added.  However, Cellect did not hold that the expiration date of patents is the only factor to consider in an ODP analysis.

In relation to the written description issue, the District Court held that the relevant patents did not provide adequate disclosure to support that a glidant was an optional ingredient in the Viberzi® drug formulations.  The Federal Circuit reversed on the basis that the relevant claims were relatively narrow and that the specification describes at least two embodiments in which the drug formulation does not require a glidant.  One embodiment disclosure was found in the specification language “…and an inert ingredient selected from silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidane…, mannitol, and magnesium stearate” (emphasis added).  Since colloidal silicon dioxide is a glidant, and the structure of the phrase implies optionality of the listed ingredients, the Federal Circuit felt that there was adequate disclosure of an embodiment where a glidant was optional.

In a concurring-in-part and dissenting-in-part opinion, Judge Dyk joined the majority’s opinion for the ODP analysis but dissented in the written description analysis.  Judge Dyk points out that the patent claims directed to the formulations where the glidant was optional were filed after the commencement of the lawsuit and that the initially allowed patent claims were only directed to formulations with a glidant.  Therefore, Judge Dyk felt that Allergan was attempting to unfairly broaden their patent claims by removing a limitation that was originally presented in every embodiment.  Judge Dyk also interpreted differently the specification phrase which the majority found to describe a glidant-free embodiment and found instead that just because one specific species of glidant was optional in a given embodiment, it did not necessarily follow that all glidants were optional in the formulations.

The full opinion can be found here.

By Ann Bernert

ALSO THIS WEEK

Platinum Optics Technology Inc. v. Viavi Solutions Inc., Appeal No. 2023-1227 (Fed. Cir. Aug. 16, 2024)

In an appeal from the Patent Trial and Appeal Board, the Federal Circuit addressed the issue of a patent challenger’s standing to appeal an adverse inter partes review ruling where the challenger’s potential infringement liability is in doubt. The case concerned a patent owned by appellee Viavi directed to optical filters comprised of hydrogenated silicon that the Board had upheld as patentable following a challenge by appellant Platinum Optics.

As with other questions of appellate standing, Article III of the U.S. constitution requires a “case or controversy” to exist on review of a decision of the Patent Trial and Appeal Board.  Before the Federal Circuit, Platinum Optics argued that it had standing to maintain the appeal due to potential infringement liability from (1) Viavi supplying bandpass filters that had been accused in a previous lawsuit to parts integrators overseas, and (2) Platinum Optics’ own development of new models of bandpass filters. Platinum Optics relied on a letter which stated that Viavi did not believe that Platinum Optics could fulfill it supply agreements without infringing products and Viavi’s history of lawsuits to demonstrate a likelihood that Viavi will sue again.

The Federal Circuit rejected this argument, finding that Platinum Optics did not have constitutional standing as required by Article III. Specifically, it had failed to meet its burden of showing “injury in fact.” The Court explained that Platinum Optic’s “unsubstantiated speculation about a threat of future suit [was] insufficient to show a substantial risk of future infringement or that Viavi is likely to assert a claim against it for the continued distribution of band-pass filters accused in Viavi II.” Similarly, the Court found that the vague and conclusory statements regarding the development of new models of bandpass filters without concrete plans was insufficient to establish a substantial risk of infringement or a likelihood that Viavi would assert a claim of infringement. The Court dismissed the appeal without reaching the merits of the case.

The opinion can be found here.

By Brittani S. Gambrell

Celanese International Corporation v. ITC, Appeal No. 2022-1827 (Fed. Cir. Aug. 12, 2024)

The Federal Circuit affirmed a decision of the International Trade Commission holding that patents on methods of manufacturing acesulfame potassium or “Ace-K”—an artificial sweetener used in products such as Equal and Coke Zero—were invalid under the “on-sale” bar of 35 U.S.C. § 102(a)(1).

It was undisputed that the claimed process had been in secret use in Europe to manufacture Ace-K sold in the United States since before the patents’ critical date, which under longstanding Federal Circuit and Supreme Court case law would operate as a bar to patentability for either the process or the product.  However, patentee Celanese argued that enactment of the American Invents Act (AIA) in 2011 had changed the scope of the “on sale” bar such that non-public use of a method could not operate as invalidating prior art.  The Federal Circuit disagreed with Celanese’s various textual and legislative history arguments in support, finding several of them to be the same as arguments already rejected by the U.S. Supreme Court in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123 (2019).  The Court concluded that Celanese had not shown any congressional intent to overrule “precedent going back to the 1800s” that an inventor need not publicly disclose details of his invention to be barred from patenting a process that had already been commercially exploited.  The decision of the ITC invalidating Celanese’s asserted claims was affirmed.

The opinion can be found here.

By Jason A. Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.