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 would-be biosimilar competition. But “if

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes involved in the timing of the FDA review of a new drug application (“NDA”) or biologic license application (“BLA”). While the purchase of a voucher can help a drug’s sponsor shorten the time to market, it can also put immediate cash in the hands of the voucher seller seeking to tide itself over, particularly during a period of flagging investor interest in the biopharma sector.
Continue Reading BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand scrutiny under the new patent court.
Continue Reading Preparing for Europe’s Unified Patent Court

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.
Continue Reading Skinny Labels May Not Be Dead: Delaware District Court Distinguishes GSK, Dismisses Induced Infringement Claim

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.
Continue Reading Juno v. Kite: Written Description and Claiming Antibodies and Chimeric Antigen Receptors—Lessons for Patent Prosecutors

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.
Continue Reading GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

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.

Continue Reading President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

Allele v. Pfizer – The Basics. On April 23, 2021, Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?

Continue Reading A Guiding Light for the Research Safe Harbor and “Research Tools”?

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.

Continue Reading “Advancing Education on Biosimilars”: Game Changer or More of the Same?

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.

Continue Reading Induced Infringement of Method of Treatment Claims: Looking to the Label and Beyond