Siegmund Y. Gutman

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The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent thicket” of 132 patents around the blockbuster drug Humira, arguing the sheer number of patents blocked…

Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification should be devoted to something that is not supposed to be part of the claim? The answer may be none at all according to a recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc. The key, according to the decision, is that the specification should not describe the negative limitation in a manner inconsistent with how it is used in the claim.

In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs (the “GSK decision,” discussed here and here), Judge Richard Andrews in the District of Delaware held that plaintiff Amarin Pharma (“Amarin”) failed to plead facts sufficient to show that Hikma Pharmaceuticals’ (“Hikma”) carved-out product label and/or public marketing statements induced infringement of Amarin’s patents. The holding suggests that carved-out labels (so-called “skinny labels), despite the GSK decision, continue to provide some measure of protection from liability based on induced infringement.

The Federal Circuit recently reversed a jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno Therapeutics, Inv. v. Kite Pharma, Inc.. This case further builds on the application of the written description requirement to claims that recite functional limitations, and is instructive to patent prosecutors.

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for?

By way of background, a sponsor can obtain orphan drug exclusivity when the FDA approves an application for a drug that has first been designated under 21 U.S.C. § 360bb of the Orphan Drug Act (ODA) for a “rare disease or condition.”  Id. § 360cc(a).  Except in any of three statutorily prescribed circumstances (§§ 360cc(b), (c)), the FDA cannot approve another application for the “same drug” for “the same disease or condition” for seven years after the first approval.

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding but sought to clarify its reasoning. GlaxoSmithKline v. Teva. Specifically, the majority stated that a generic manufacturer’s touting of AB equivalence to a brand drug is generally not evidence of intent to induce infringement—but in the specific facts of this case it did support inducement, because the Court found ample evidence tying claim limitations to statements in Teva’s label even though the patented method was omitted as a distinct indication. The Court also found that Teva’s advertising statements regarding treating “heart failure” evidenced intent to induce physicians to prescribe the drug to treat CHF.

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies.

The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was introduced in the Senate in February 2021 and sped through the House to enactment on April 23, less than three months later.

In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed

The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.

Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly infringe the claims, plaintiffs must sue under a theory of induced infringement—i.e., that the generic or biosimilar developer recommended, encouraged, or promoted a patented use for the drug. Demonstrating induced infringement most often involves the label of the defendant’s product, but increasingly may involve non-label evidence such as the defendant’s press releases, brochures, product catalogs, advertisements, and statements to the FDA, doctors, and investors. This non-label evidence is likely to be especially significant in the biologic context.