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Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021)

For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range.  In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges.  Below, we discuss two of those cases in our “Also This Week” section.  For our write-up on last week’s Indivior case, see here.  In this case, the issue is whether a patent claiming a number that was specifically disclosed in the patent satisfied the written description requirement.  Based on the facts of this particular case, the Federal Circuit affirmed a district court finding that it did not.

The patent in this case claims a method for treating multiple sclerosis with a drug called dimethyl fumarate (“DMF”).  Specifically, it recites providing a “therapeutically effective amount of dimethyl fumarate” in the amount of “about 480 [milligrams] per day.”  The original patent specification “casts a wide net for a myriad of neurological disorders,” of which MS was just one.  It was originally titled “Nrf2 Screening Assays and Related Methods and Compositions,” and it described five methods to explore a potential protective role for activation of the Nrf2 pathway.  Three methods related to screening, and two related to treatment.  “The totality of the specification focuses primarily on drug discovery.” 

In the entire specification, there was only one paragraph that discussed possible dosage levels for DMF, as follows:

Effective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents. For example, an effective dose of DMF or MM[F] to be administered to a subject orally can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses.

At issue was whether this disclosure was enough to satisfy the written description requirement for a claim reciting “therapeutically effective” treatment of MS by using 480 mg, a number specifically stated in that paragraph.  The district court held that was not.  A Federal Circuit panel affirmed.  Like in last week’s Indivior case, one judge dissented.

The finding was based on a failure to show that the inventors actually conceived the invention of treating MS using a therapeutically effective amount of DMF in the amount of 480mg as of the filing of the patent application’s provisional application.  It appears that the breadth of proposed dosage amounts (from 200 to 800 mg per day) was so broad that there appeared to be no indication that the inventors conceived of a specific amount (480 mg) within that range, even though that amount was specifically named as the outer boundary of one of the proposed ranges.

It appears that both the district court and the Federal Circuit were impacted by the fact that the 480 mg/day dosage was not considered until August 2006, after Phase II clinical trials had shown that 720 mg/day was effective but 120 and 360 mg/day were not.  In February 2007, the provisional application that led to the patent was filed, including the paragraph above that referenced a 480 to 720 mg/day dosing range.  But that was before Biogen had performed any clinical trials confirming that 480 mg/day would be therapeutically effective.  The courts also appear to have been influenced by changes that were made to the patent application as clinical data came back and showed the effectiveness of 480 mg/day in treating MS.

Specifically, the Federal Circuit noted in its analysis that “[t]he DMF480 dose is listed only once in the entire specification” and that “the sole reference to DMF480 . . . appears at the end of one range among a series of ranges, including DMF concentrations” from 100-1,000, with several smaller ranges in between.  The Court noted that DMF720 was more clearly identified---and was known to be effective as of the priority date.  The Court also noted that the emphasis in the specification tended to be on “basic research and broad DMF-dosage ranges,” which showed that the inventors “did not possess a therapeutically effective DMF380 dose at the time of filing.”

Judge O’Malley filed a lengthy dissent, in which she started by challenging the majority’s interpretation of the term “therapeutically effective.”  Judge O’Malley believed the majority was using “clinical effectiveness” and ability to pass FDA regulations, rather than therapeutic effectiveness.  Starting from that proposition, she opined that the specification shows that the inventors had possession of 480 mg/day as a therapeutically effective dose of DMF in 2007.

The Court’s decision can be found here.

The same day, the Court issued a non-precedential decision from a parallel appeal from an IPR decision, which had found the patent not obvious. The Court dismissed the appeal as moot.

A copy of the opinion can be found here.

ALSO THIS WEEK

The Federal Circuit issued two precedential decisions concerning the inter partes reviews filed by Moderna against patents owned by Arbutus Biopharma. The cases concern Moderna’s COVID-19 vaccine.

ModernaTx, Inc. v. Arbutus Biopharma Corp., Appeal No. 2020-2329 (Fed. Cir. Dec. 1, 2021)

The Federal Circuit affirmed a PTAB finding that certain claims from Arbutus’s U.S. Patent 9,364,435 were not invalid as obvious.  The patent claimed certain ranges of different lipids in a nucleic acid-lipid particle.  The prior art disclosed two of those types of lipids in ranges that overlapped the range claimed in the patent.  Moderna argued that the third lipid could be deduced from simple subtraction.  Based on this argument, Moderna argued that the presumption of obviousness should apply pursuant to In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).  The Board found otherwise, and the Federal Circuit affirmed.

First, the Court addressed the issue of standing, and found that Moderna had Constitutional standing to pursue an appeal.  Even though Arbutus had not lodged a specific threat of infringement, the totality of statements that Arbutus had made publicly established that there was a live case or controversy.  Moreover, Arbutus had done nothing to disabuse Moderna or the Court of those concerns.

Having found standing, the Court proceeded to the merits.  The Court agreed with the PTAB that Moderna’s arguments were overly simplistic, and took too many assumptions in concluding that the third range was ascertainable through simple subtraction.  The Court held that the presumption of obviousness for overlapping ranges therefore did not apply, and the Board has properly ascertained that the patent was not obvious based on the facts of record.

The Court’s decision can be found here.

ModernaTx, Inc. v. Arbutus Biopharma Corp., Appeal Nos. 2020-1184, -1186 (Fed. Cir. Dec. 1, 2021)

In this parallel case, the Federal Circuit dismissed an appeal concerning an IPR based on Arbutus’s U.S. Patent 9,364,435, which the PTAB had also held was not invalid as obvious.  At the time the appeal was filed, the patent was owned by Protiva Biotherapeutics, Inc.  It appears the patent may have been transferred to Arbutus during the appeal.  To establish Constitutional standing, the appealing party must establish that it had standing as of the date the appeal was filed, and that a case or controversy has continued throughout the appeal.  Unlike in the case above, Protiva had not given Moderna any indication it might file an infringement suit against Moderna.  Moderna was also a licensee of the patent as part of a patent license that covered a number of patents.  The Court dismissed the appeal because “Moderna lacked standing at the time the appeal was filed.”

The Court’s decision can be found here.

By Nika Aldrich

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