Supreme Court Grants Cert in Amgen v. Sandoz & Sandoz v. Amgen

By Jason Rantanen

Today, the Supreme Court granted certiorari in two dueling petitions involving the Federal Circuit’s 2015 interpretation of the Biologics Price Competition and Innovation Act of 2009.  Here are the questions presented:

Amgen v. Sandoz

(1) Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor’s sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii).

Sandoz v. Amgen

(1) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars – as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval.

Kevin Noonan discussed the underlying opinion on the PatentDocs blog, describing it as “a seriously fractured decision….”

You can read the Federal Circuit opinion here:  s15-1499

11 thoughts on “Supreme Court Grants Cert in Amgen v. Sandoz & Sandoz v. Amgen

  1. Without reading the other comments, this could have been settled before June of last year and should have led to a denial due to concerns about ripeness and will likely lead to a denial for improvidently granted. Original and concurrent jurisdiction matters will likely tie in. Frankly, many of these discussions need to happen privately within the USPTO and on a case-by-case basis rather than turning nuanced monopoly matters into a trial advocacy parlor game for spectators.

  2. Mr. Noonan also stated there as to this statute that: “The BPCIA is a component of the healthcare law commonly termed “Obamacare” and provides for the first time in the U.S. an abbreviated pathway for FDA approval of so-called “biosimilar” drugs, generic versions of biologic drugs.”
    Do you think the members of Congress getting ready to kill the entire “Obamacare” legislative package know that?

      1. Repeal and replace

        “Replace” with what exactly? “Something better”? LOL That’s not going to happen with the Republicans in charge … unless, of course, you’re wealthy.

        Never mind as well that there were far better options out there when the ACA was crafted. But we couldn’t even discuss those because “socialism!”

        Probably no piece of new legislation in the past 25 years has saved more lives and helped more people than the ACA. But screw all that. Rich people need a tax break! And poor people deserve to die or else they’ll get lazy. At least make we need them to make poor people jump through a ton of hoops and take drug tests. Well, the poor black people anyway. They’re the worst! Them and uppity women who can’t keep their legs crossed and demand that everyone pay for the sltty behavior. Just ask one of the many professional r@cists and woman h@ters who helped propel the incompetent orange maniac to the top. They’re very serious people.

        What do we think? 2 years for impeachment? Or is this psy ch0 going to turn his approval ratings around magically? Maybe a nice little war will help. Nobody can see that coming….

        1. MM, as Obamacare kicks in we find premiums that bankrupt and give no protection due to extremely high deductibles. It is as America no longer had insurance, unless that is, one is poor and is subsidized.

          Yeah, a great wealth transfer from the middle class to the poor where some get healthcare, the poor, and the others get the shaft.

          1. premiums that bankrupt

            But still cheaper for nearly everybody than what existed before, particularly people with pre-existing conditions.

            It is as America no longer had insurance

            Absolute horseshirt, Ned. Once again, your ability to disgust with ignorance and misinformation is unmatched. Where do you come up cr@p like this?

            unless that is, one is poor and is subsidized.

            Getting affordable healthcare to people who would otherwise have none is a hugely important aspect of the ACA. Without improved access, those people are going to get sick more often and it’s going to cost everybody more to deal with it. The cost savings resulting from these subsidies (mainly the Medicaid expansion) was a huge driver that led to passage of the ACA.

            a great wealth transfer from the middle class to the poor

            False.

            others get the shaft

            If there’s some tiny fraction of people who are getting “the shaft” because they lie on some inflection point in the system, then the most logical solution would seem to be to deal specifically with that problem.

            But these alleged people “getting the shaft” from the ACA (I’ve yet to meet a single such example) are not what’s driving the Republicans repeal efforts. If anyone thinks that is the case, they are utterly cl u eless. The Republican’s dream, remember, is to achieve something that nobody except the psy ch0tic (R) congresscritters actually wants: complete dismantling of government provided healthcare to be replaced with privately run schemes. They tried this same game with Social Security and they’ll try it again.

            The ACA itself, by the way, has tons of popular support, in spite of the Republicans relentless attacks. More people would prefer to keep it in place or expand it than repeal it.

            wealth transfer from the middle class to the poor

            As opposed to a wealth transfer from everybody to the super rich. That’s the Republican game plan. Always has been. Once you understand this, then all the maneuvering makes sense. You think income disparity isn’t going to skyrocket again under the orange maniac? We are so effed.

            1. “But these alleged people “getting the shaft” from the ACA (I’ve yet to meet a single such example)”

              You’re invited to join me in NC at Easter or next thanksgiving. You will meet such people and you will see their premiums. Before and after.

            2. A pretty good write up MM. Note though the hypothetical nature of the “savings” they tout. People aren’t that inclined to believe they saved 30% with respect to an imaginary number if their premiums went up 50% anyway over the course of the prez.

          2. “But still cheaper for nearly everybody than what existed before, particularly people with pre-existing conditions.”

            You say that but that hasn’t been my fam’s experience. Not at all. I don’t know who these other people are but it sounds wrong. Seems like there are enough people in my fam’s boat to have their voices heard.

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