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Intellectual Property

Amgen asks the full Federal Circuit to reconsider its PCSK9 loss

Earlier this year, in October, the Federal Circuit vacated Amgen’s hard-earned injunction against Praluent®, the only other PCSK9 drug competing with its own, Repatha®.  The case has been remanded to the District Court of Delaware for a new trial on the validity of Amgen’s patents.  Before that could happen, however, earlier this week Amgen petitioned the Federal Circuit for en banc review of its October 5, 2017 decision that cut against Amgen.  What are Amgen's chances?

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If Oil States eradicates IPRs, how much will AbbVie gain? Coherus lose?

The Supreme Court has heard oral argument in Oil States v. Greene’s Energy, and a decision whether IPRs are unconstitutional is currently pending.  For companies currently embroiled in IPRs that could directly impact their bottom line, the Supreme Court’s decision could be very tangible.  AbbVie ($ABBV) and Coherus Biosciences ($CHRS) are a case in point. 

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Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including Dr. Reddy’s, Zydus, Cipla, and Lotus Pharmaceutical.  Those ANDAs have triggered corresponding Hatch-Waxman lawsuits from Celgene.  Among the asserted patents, most of them expire by 2022, with the exception of two polymorph patents that could extend Revlimid® monopoly until 2027.  The lawsuits are in their early stages, but an upcoming Markman hearing in the case against Dr. Reddy’s is shaping up to be critical to whether Celgene can protect is Revlimid® monopoly past 2022.  See our recent publication in IPWatchdog outlining the case in more detail.

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Our Top Five IP Dealmakers Forum Tweets...

One of the events of the year in the IP monetization world is the IP Dealmakers Forum. As usual, Twitter (e.g. @ipdealmakers, @iam_magazine, and others) has been a great resource for those hoping to follow the conference without actually attending. Here is our take on the Top Five IP Dealmakers Forum Tweets...spiced with a bit of our commentary on the points being made.

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Markman Advisors
Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

Amgen's Enbrel® monopoly is currently protected by two antibody patents that are not scheduled expire for another 10 years.  In a recent case involving Amgen, Amgen v. Sanofi, the Federal  Circuit 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. Sanofimade a validity challenge to Enbrel®’s patents easier.  See our recent publication in IPWatchdog.

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Markman Advisors
Notable points from the Tribe's Reply Brief in Restasis® briefing before the PTAB.

The problem with these arguments is that even if they are all true (which is questionable,) they are besides the point.  The issue at stake is whether renting sovereign immunity to evade having to defend the validity of your patent is either permissible or should be permissible.  Indeed, Judge Bryson admonished Allergan for being “conspicuously silent about the broader consequences of the course it has chosen.”  (Allegan v. Teva, Dkt. 522 at 4-5).  Mr. Saunders op-ed in The Wall Street Journal is equally silent. 

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Are patents public rights? A summary of the Respondents argument in Oil States.

Viewed through that lens, the Respondents argue there is nothing unconstitutional about IPRs.  Congress was expressly given the power to grant patents within the Constitution.  Congress has delegated that power to a federal agency, namely, the USPTO.  Any “right” to a patent therefore derives directly from a Federal Government action, and by that token, it is a public right.  In other words, patents do not embody a natural right of the inventor to exclude others from using his or her invention.  Rather, a patent only exists because Congress has expressly provided for it. 

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