Amgen v. Sanofi – How Wands Factors make Biotech Claims “Magically” Disappear

While this recent Fed. Cir. decision – Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir., Feb. 11, 2021) seems predictable, given the fate of antibody claims that recite the target and the function of antibody binding thereto, there are a few interesting wrinkles to comment on. A Fed. Cir. panel of Judges Lourie, Prost and Hughes, Lourie writing, affirmed the district courts finding that Amgen’s claims failed the enablement test of s. 112. Evaluating the Wands factorsthere are seven of them—to determine whether or not the claimed antibodies would require undue experimentation to locate ones falling within the scope of the claims, the panel relied on its fairly extensive precedent, most of it unfavorable to Amgen, and concluded that “lack of enablement [was found] due to the undue experimentation required to make and use the full scope of the claimed compounds that require a particular structure and functionality.” As the panel noted, citing McRO 959 F.3d at 100:

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Interesting Developments at the EPO

Guest post from Rigel Menard.

There are changes at the EPO coming that require the specification to better reflect the allowed claims. In applications in which multiple inventions are disclosed, the new rules seem to be requiring editing the specification in some significant ways. In the case of this application, the term “embodiments” was edited to be used in conjunction with only the allowed claims. The specification in this matter is almost 300 pages and the editing performed was quite expensive. Further edits were made to the Summary and Technical Field to make sure they correspond only to the allowed claims.

To help avoid at least some of these costs, it seems that the term “embodiments” or similar (I am not sure if they view “aspects” or “examples” the same way) should be avoided for applications that will be filed in the EP to save costs for clients.

An explanation from Thomas Franks-Moore at Keltie details:

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Illumina v. Ariosa – Ariosa Petitions for Cert.

The first panel decision below can be found at 952 F.3d 1367 (Fed. Cir. 2020). I posted on this decision on June 1, 2020, days before the Fed. Cir. issued a modified panel decision in August, 967 F.3d 1319 (Fed. Cir. 2020) that essentially affirmed the first panel’s holding that the claims in two Illumina patents, U. S. Pat. Nos. 9,580,751 and 9,738,931, claimed patent eligible subject matter. Please read my June post for more background. Claim 1 of the ‘751 patent reads as follows:

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American Axle & Manufacturing v. Neapco Holdings–Part II

In my first post on American Axle’s Petition for cert., I focused on the substantive arguments of the parties. Almost as interesting is Part 5 of the Petition, in which AA argues that this is a good case for the S. Ct. to grant the Petition. I will try to summarize the arguments. But the Section starts off by arguing that the invention in question is “not a run-of-the-mill Section 101 case” like attempts to patent business methods or diagnostic tests: “This case is different—[AA’s] claims ‘are directed to a process for manufacturing car partsthe type of process which has been eligible since the invention of the car itself.’”

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