Regeneron ($REGN) and Sanofi released positive topline results from their ODYSSEY clinical trial Praluent®. In addition was the announcement that prices for Praluent® may be cut. Investors who may have grown skeptical with the new PCSK9-inhibitor class may now be interested again, which may include the pending patent lawsuit between Amgen ($AMGN) and Regeneron. What is happening in the case?
Read MoreThe PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents. The IPRs were not filed by Sandoz, but they will most likely affect Sandoz. Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®. And Sandoz is going to trial against Amgen in April. How do Coherus IPR decisions affect Sandoz's decision to launch at risk? Or to settle with Amgen?
Read MoreFDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars. Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.” Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting? Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly.
Read MoreWith BlackBerry's new mega-patent case against Facebook, Instagram, and WhatsApp, the company's long-awaited transformation into a serious patent assertion entity is undoubtedly complete. Even a simple perusal of BlackBerry's complaint reveals that the company has thrown significant resources at the case in the hopes of securing a windfall licensing fee from Facebook. At the same time, it is also clear that Facebook has rebuffed BlackBerry's pre-litigation attempts to license the patents. Considering that the case is likely much more material to BlackBerry investors than to Facebook holders, below are three critical questions that BlackBerry investors should be asking as they evaluate this new development.
Read MoreCorcept Therapeutics recently received a Paragraph IV notice letter from Teva for its drug, Korlym®. The market’s reaction crushed the stock, sending it from approximately $23 to roughly $17 within a day. Corcept Therapeutics has essentially one drug, Korlym® (mifepristone). But whether Teva will enter with a generic version of Korlym® any time soon depends directly on the patents that Corcept has in its arsenal. What are those patents? Is the market’s reaction justified? Or is this a buying opportunity?
Read MoreCloudflare recently prevailed on its motion to invalidate patents as ineligible in a case commenced by Blackbird Tech. But Cloudflare’s win may be in jeopardy. Two recent decisions from the Federal Circuit have held that winning on early Alice motions, like the one on which Cloudflare prevailed, will now be more difficult.
Read MoreThe 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?
Read MoreAnyone who has followed Federal Circuit cases addressing Alice decisions has felt the whip-saw brain squeeze of trying to reconcile them all. While some clear guidelines have emerged that have made assessing whether a given patent is susceptible to Alice, there remains a thick, gray cloud over how, exactly, the two-step framework applies in practice. Two recent decisions from the Federal Circuit, Berkheimer v. HP and Aatrix Software v. Green Shades Software, may have established some more concrete guidance on handling early Alice motions in patent cases.
Read MoreSandoz was denied institution on two IPRs against Humira® patents owned by AbbVie. As we previously discussed, in late 2017, Sandoz filed eight different IPRs against Humira® patents. Two of those IPRs just failed to reach institution. What are the take-aways, for Sandoz and any other Humira® biosimilars?
Read MoreDespite lingering concerns about the future profitability of Car-T based cancer treatments, there is no doubt that 2017 was a year of great change in the space. From the first FDA-approved product offering to the acquisition of two leading companies, Kite and Juno, by biotech behemoths Gilead and Celgene respectively, 2017 was truly Car-T's year in the sun. While investors in both Kite and Juno were rewarded for their belief in Car-T's commercial potential, it would be a mistake to ignore the ongoing patent dispute between these fierce competitors.
Read MoreGilead’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?
Read MoreSandoz 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?
Read MoreA 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.
Read MoreThe 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.
Read MoreIn 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.
Read MoreDupixent® 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.
Read MoreAmgen’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?
Read MoreThe questions left standing by the Supreme Court's TC Heartland patent venue decision are slowly being answered by District Courts around the country. One question in particular poses an interesting challenge for litigants arguing for or against whether venue is proper: What role if any, do Amazon's Fulfillment Centers play with respect to establishing venue?
Read MoreIn 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.
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