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Posts tagged inter partes review
Will AbbVie’s latest patent suit against Sandoz mean a Humira-biosimilar before 2023?

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar.  Sandoz is the fifth biosimilar to throw its hat in the ring.  Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?

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Can Unified Patents survive the Federal Circuit’s RPI decision?

The Federal Circuit recently issued a strong decision instructing the PTAB to rethink the way that it decides who is an RPI (real-party-in-interest).  While the decision involved RPX, it presents a more existential threat to Unified Patents, which has risen as one of the most prolific non-party filers of IPRs.  Can Unified survive the CAFC’s RPX decision?

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Will the Federal Circuit’s tribal immunity decision in St. Regis Mohawk Tribe v. Mylan make it to the Supreme Court?

The Federal Circuit has sided against the Tribe and Allergan.  On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®.  What are the takeaways from this decision?

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Senator Hatch Thinks Some Industries Deserve Patents More Than Others

Senator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies.  Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.  

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Takeaways from the Tribe’s Oral Argument at the Federal Circuit: St. Regis Mohawk Tribe v. Mylan

On June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents.  The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs.  While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.

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How will Oil States impact VirnetX? Will VirnetX's damages be increased to $1.5B?

Our earlier post on VirnetX’s recent $502M jury verdict commended the company and its counsel on an incredible win, but nevertheless pointed out that it might be for naught.  The patents asserted in the trial for the $502M damages currently stand invalid pursuant to petitions for inter pares re-examination and inter partes review.  But what about Oil States?  The case is currently pending before the Supreme Court, and it addresses the constitutionality of petitions for inter partes review (IPR).  The case has already heard oral argument, and a decision is expected imminently.  Some commentators have suggested that if the Supreme Court holds IPRs unconstitutional, then that will vacate the invalidity decisions of VirnetX’s patents from the PTAB, and nothing will finally stand in the way of VirnetX’s damages.  What are the considerations that may keep alive VirnetX's prospect of collecting damages?

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The PTAB's Allergan / St. Regis Mohawk Decision: Explained

The PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe.  On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity.  What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs?  And what are the ramifications for similar deals in the future?

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Will Amgen's latest Neulasta® patent loss against Sandoz read-through to other biosimilars?

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?

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Can Coherus invalidate Amgen's Enbrel® patents? Part 2

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. 

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Sandoz’s aBLA for HUMIRA® has been accepted by FDA -- what happens next?

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? 

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What is the Dupixent® patent fight among Amgen, Regeneron and Sanofi all about?

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.

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Can Coherus invalidate Amgen’s Enbrel® 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?

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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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