Gilead’s new HIV drug, Biktarvy®, has received FDA approval.  Almost immediately, Gilead was hit with a patent-infringement lawsuit by ViiV Healthcare, which is owned by GSK, along with Pfizer and Shionogi.  What is Gilead’s exposure?

Sandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®.  No biosimilar has yet to receive FDA approval for Neulasata® within the U.S.  Sandoz recently announced successful Phase 1 data indicating it may be getting closer.  Further, other biosimilars for Neulasta® are in the works.  Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?

A number of generics are moving in on Celgene's Revlimid.  Leading the pack is Dr. Reddy’s, and although Celgene has asserted numerous patents against Dr. Reddy’s proposed generic, a single issue has crystallized in advance of an upcoming Markman hearing that could make or break the case.  

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

In an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept).  Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response. 

Sandoz, the generic arm of Novartis, has announced that its abbreviated Biologic License Application (aBLA) for a Humira® biosimilar has been accepted by FDA.  Now that Sandoz’s aBLA has been accepted for review by FDA, what happens next on the patent front? 

Dupixent® is a recently-released drug forecasted to reach $4B in annual sales.  The drug is a co-venture between Regeneron and Sanofi, which also teamed up to launch Praluent®, one of the two available drugs within the new class of PCSK9-inhibitors.  In the case of Praluent®, Amgen brought Regeneron to court arguing that Praluent® infringed Amgen’s patents and thus the drug should be taken off the market.  Once again, Amgen, Regeneron and Sanofi are back in court.  Amgen has squared off against Regeneron and Sanofi and argued that Dupixent® infringes one of Amgen’s patents.

Amgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences.  Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent.  The institution decisions are due before the trial:  March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR.  If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date.  What are Coherus's invalidity arguments?

In February 2016, Amgen brought suit against Sandoz in connection with its proposed biosimilar for Amgen’s Enbrel® blockbuster.  The case is on a relatively fast track, currently scheduled to go to trial later this year in April.  Some investors have inquired about whether Sandoz has a strong obviousness-type double-patenting invalidity defense for the ‘182 patent.

Allergan’s PTAB Restasis® fight continues, and a recent email tiff before the PTAB between the St. Regis Mohawk Tribe and Mylan has added a further wrinkle to this case.  As we previously blogged, a recent decision by the PTAB (between the University of Minnesota and Ericsson) held that a State’s sovereign immunity against an IPR is waived under the Eleventh Amendment where the State affirmatively asserts the challenged patent in litigation.  That decision appeared to potentially doom Allergan’s strategy of passing off its Restasis® patents to the Tribe to defend against the IPRs.  A recent email exchange between the Tribe and Mylan (the Petitioner in the pending Restasis® IPRs) at the PTAB suggests the University of Minnesota decision may not, in fact, be the nail in the coffin that Mylan had likely hoped.  But it also shows that the Tribe may not be on as sound footing as it is claiming.

In the latest twist in the saga pitting sovereign immunity against inter partes review, the PTAB issued a decision on December 19, 2017 that potentially jams a spoke into the wheels of future partnerships between brand pharma and Tribes.  What does this decision bode for Allergan’s Restasis® deal with the St. Regis Mohawk Tribe?  What are the consequences of this decision?

Since the first BPCIA cases hit the courts a few years ago, the Federal Circuit and the Supreme Court have slowly been entangling the knots and confusions around the complicated regulatory scheme.  Innovator companies and biosimilars have wrangled over the “patent dance” and the 180-days notice of commercial marketing, including what’s required, what’s not, and who can leverage a regulatory tactical advantage.  A case between Amgen and Sandoz has helped resolve many of these issues, and this week, the Federal Circuit took another step towards gutting the statute.  What are the take-aways?

Bitcoin is through the roof, and cryptocurrency technologies are drawing significant investment. Yet, regardless of whether bitcoin is a bubble, the long-term story remains that blockchain is slated to be the next potential big disruptive technology. Like any disruptive technology, those thinking ahead, including startups and established institutions, know that acquiring a portfolio of patents on blockchain features or uses could pay enormous dividends years from now. But the Supreme Court’s harrowing precedent in 2014, Alice v. CLS Bank, which has already doomed so many software patents, may create a formidable obstacle to acquiring blockchain patents.

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?

On December 1, 2017, several friends of the PTAB submitted amicus curiae briefs in connection with the Tribe’s motion to dismiss the pending IPRs challenging Allergan’s Restasis® patents.  What did the amici argue, on both sides of the issue?

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. 

In the course of eviscerating IPRs through Oil States, pharma could theoretically open the door to jury trials for its patents.  That may not be a good thing for branded pharma.

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.

A recent decision by the PTAB denying institution of an IPR related to Rituxan(R) shows that disagreements exist within the PTAB over the precise standard that must be met for institution. 

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.