Posts Tagged: "amgen"

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation. Judge Lourie authored the opinion.  Amgen v. Sanofi (CAFC, Feb. 11, 2020)

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New Jersey in Immunex Corporation, Amgen Manufacturing, Limited, Hoffman-La Roche Inc. v. Sandoz, Inc., Sandoz International GMBH, Sandoz GMBH, holding that Sandoz failed to prove that the asserted claims were invalid for obviousness-type double patenting (ODP), failure to meet the written description requirement, and obviousness for lack of motivation to combine the prior art references. The ruling for now blocks Sandoz from marketing its biosimilar version (Erelzi) of the popular rheumatoid arthritis drug, Enbrel. Judge Reyna dissented, arguing that certain clauses of the licensing agreement were illusory, thereby rendering the agreement an effective assignment for purposes of ODP.

Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. Patent No. 5,856,298 (the ‘298 patent) belonging to Amgen was infringed by Hospira and not invalid; 2) 14 batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 USC § 271(e)(1); and 3) Amgen had proven that it was entitled to a jury verdict of $70 million in damages. Additionally, the CAFC affirmed the jury’s verdict of noninfringement of U.S. Patent No. 5,756,349 (the ‘349 patent).

The Federal Circuit issued an opinion on July 29 affirming the District Court for the District of Delaware’s dismissal of Amgen Inc. and Amgen Manufacturing Ltd.’s (collectively, “Amgen”) complaint alleging infringement of U.S. Patent 8,273,707 (the “’707 Patent”) for failure to state a claim.  The district court held that prosecution history estoppel barred Amgen from succeeding on its infringement claim under the doctrine of equivalents.  Amgen Inc. v. Coherus BioSciences, Inc., No. 18-1993 (Fed Cir. July 29, 2019) (Before Reyna, Hughes, and Stoll, Circuit Judges) (Opinion for the Court, Stoll, Circuit Judge). 

This week in Other Barks and Bites: the Senate Judiciary Committee plans to go after drug patents to promote access to generic medications; Apple faces another patent suit in the Eastern District of Texas in the midst of attempts to remove its business presence from the district; China enacts a code of conduct for patent agents; Samsung and Huawei enter into an agreement to terminate their multi-year legal battle in the Android sector; the makers of Fortnite face yet another copyright suit over dance moves; Warner Bros. strikes down a Kickstarter campaign intending to distribute edited versions of The Departed; and a Delaware jury upholds cholesterol treatment patents owned by Amgen.

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofi made a validity challenge to Enbrel®’s patents easier.

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023… Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues.

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery in the district court. The Court also found that Amgen failed to meet the requirements for mandamus relief. Amgen Inc. v. Hospira, Inc., (Fed. Cir. Aug. 10, 2017) (Before Dyk, Bryson, and Chen, J.) (Opinion for the court, Dyk, J.)… When filing a BPCIA paragraph (l)(3) list of patents that could potentially be infringed by a biosimilar, all patents that could reasonably be infringed, based on available knowledge without discovery, should be included on that list. In an interlocutory appeal, the Federal Circuit lacks “collateral order” jurisdiction to compel a district court to order discovery concerning non-listed patents, nor is mandamus warranted, because relief is available on appeal from a final judgment.

A $1 trillion a year industry not wanting to pay innovators less than a 1% royalty on the innovations they appropriate (i.e., steal) for their own profits seems like a terrible price to pay given the national security and economic consequences of forfeiting our world leadership to the Europeans and Chinese… Google and Uber are locked in a patent battle over self-driving automobiles, so does that make Google or Uber a patent troll? What about General Electric, Apple, Samsung, Microsoft, Cisco, Oracle, Whirlpool, Kraft Foods, Caterpillar, Seiko Epson, Amgen, Bayer, Genzyme, Sanofi-Aventis, and Honeywell, to name just a few?

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably determine which of its patents might be infringed by the biosimilar. Now, potentially meritorious patent infringement questions could be kicked far down the road. This could lead to delayed launch of the biosimilar product, possibly through a decision not to launch at risk or possibly by way of injunctive relief outside the BPCIA.

Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s own IL-4 inhibitor developed during the 2000s, which failed in phase 2 clinical trials… The major impetus behind this suit was Sanofi-Aventis and Regeneron’s discovery that Amgen hired litigation counsel to assert the ‘487 patent and is also working on retaining experts. The plaintiffs believe that the only likely target for any potential Amgen infringement suit asserting the ‘487 patent would target Dupixent, “the only IL-4 inhibitor expected to come to market in the near future.”

On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for a permanent injunction against Regeneron’s new PCSK9-inhibitor cholesterol drug. Both Amgen and Regeneron each independently spent billions of dollars over the past decade-plus developing a new class of cholesterol drug. The drug itself comprises an antibody that binds to PCSK9 proteins… Whereas Regeneron managed to be the first to market, Amgen succeeded in getting to the Patent Office first. Amgen originally sued Regeneron, along with Sanofi, its European partner, in October 2014. Amgen asserted three patents directed to antibodies that bind to PCSK9. Over the next month, Amgen commenced additional lawsuits as new patents issued from the Patent Office. The cases were eventually consolidated, but Amgen eventually went to trial against Regeneron on only two of the originally asserted patents.