Monthly Archives: January 2018

Biotech Patent Litigation


Short Version:

If you read only one article on biotech patent litigation, read this one:

Litigating Biotechnology Patents: The Next Frontier for Patent Litigation in the United States by Baker Botts. 10/30/2017

Long Version:

I compiled this list of biotech litigation readings in anticipation of the patent patent licensing dispute Arbutus vs. Acuitas on LNP drug delivery technology. Other big names such as Moderna, Sangamo, Alnylam, CRISPR Therapeutics will also be critically affected by the outcome of this trial. They are all using LNP for their drug delivery.

General discussion on Litigation and Investing

  1. Litigation Trading: An Introduction to Wall Street’s Interest in Patent Cases
    This article is quite basic.
    ===Begin Quote===
    In particular, investors are primarily interested in two factors: the financial impact that a litigation may have on a company—considering the value of both potential damages and injunctive relief—and the expected timing.... to make use of information that, while publicly available as part of the court’s docket, ...

    litigation could move stock prices if the amount at stake is significant relative to a company’s financial metrics

    Public intellectual property companies (PIPCOs) ...

    As one of the first tests of a party’s legal claims, claim construction rulings can directly impact the range of potential case outcomes, thus affecting the overall value of the case from an investment standpoint.

    Summary judgment rulings can also trigger market-moving changes to the value of an ongoing litigation, as decisions granting or denying judgment on targeted issues directly impact the ultimate outcome of a case.

    ...damages award does not necessarily mean that a company’s stock price will rise. Going into a trial, the market has usually accounted for an expected outcome in the company’s stock price.

    Inter Partes Review (IPR) proceedings allow anyone to challenge another party’s patent in litigation before an administrative law judge at the Patent Trial and Appeals Board.

    IPR proceedings as part of what appears to be a reverse monetization strategy in which the investor challenges the validity of a company’s patents while shorting the stock or trading options contracts so as to profit from a decline in share prices.

    The most widely publicized example of hedge funds making use of IPR proceedings involves petitions filed by the Coalition for Affordable Drugs ...

    ===End quote===

  2. Finding Alpha In Event-Driven Patent-Litigation Investments

Biotech specific expert opinions and case reviews

  1. Pharma and Biotech Patent Litigation by Corporate Disputes.===Begin Quote===
    Instead, companies are routinely faced with complex considerations bearing on how an allegedly infringing product is manufactured, marketed or used.Traditionally originators vs. generics. Actions against parallel traders and counterfeiters are another part of ongoing litigation activities...Infringement actions of that kind focus on legal rather techinical questions, on the interpretation of the law rather than on claim construction...

    ... litigation strategies will have to reflect the legal uncertainties associated with claims, the construal of which by a court is not reliably predictable ....

    ... the debate is unfolding in such a way that virtually all patent plaintiffs are cast in a negative light and a pall is cast over the strength of all patents.

    But the focus of the EU Commission’s endeavours is on identifying and sanctioning settlement agreements they perceive to be anti-competitive... the difficulty of settling pharma patent disputes without drawing antitrust scrutiny is certainly one of them.

    a biosimilar may be subject to relatively high development costs; ...the difficulties that may arise in simply identifying the relevant set of patents at issue. Also, since biosimilars are likely to be priced closer to the reference products than small-molecule generics, the potential damages exposure may be less.

    The most pressing issue for patentees, whether in the pharma and biotech space or elsewhere, tends to be obtaining an injunction...One of the prongs of this test is a showing of irreparable harm. This can involve evidence on the degree of substitutability between the patented and infringing products, and lost market share, revenues, brand recognition, goodwill in the marketplace, and so forth.

    As long as unitary patent protection and enforcement is not available, holders of pharmaceutical patents must carefully define where and how to start legal action on the basis of their European patent...companies intending to launch their product prepare for litigation by taking into account the possibility of being stopped in one country – that is, they provide for alternative manufacturing sites and supply routes.

    pharma is one of the few industries where the vast majority of lawsuits are between competitors.

    The prevalence of electronically stored information (ESI) has had a dramatic impact on the cost and complexity of patent litigation. Notwithstanding that effort, satellite disputes over what documentation was not retained arise with regularity.

    Companies often find themselves in a ‘win-at-all-costs’ situation, but this may not be justified given the stakes in a particular lawsuit.

    a strong enforcement system begins with a strong examination system. ... by easing fees on ‘micro’ entities and adopting procedures that allow start-up companies to secure patents swiftly and efficiently, in recognition of how critical IP protection can be when a firm is at a fledgling stage.

    Problems with enforcement still occur, in particular with respect to obtaining evidence, the long duration of proceedings, high costs versus the small amount of awarded damages and limited effect of deterrence.

    more patents and more cases, increasingly involving disputes between originators, and patents with broader claims potentially covering a greater number of various products...the opportunity to use mediation or arbitration proceedings to solve in particular multi-jurisdictional patent disputes in the pharmaceutical and biotech sector seem to be underexplored.

    Courts in Eastern Europe had the reputation of being against patentees,

    Supreme Court is continuing a nearly decade-long streak of patent decisions, the vast majority of which have cut back on what may be patented or raised the bar for successfully asserting patents.

    === End Quote===

  2. Litigating Biotechnology Patents: The Next Frontier for Patent Litigation in the United States by Baker Botts.
    I am not goint to quote anything here. Just read the article yourself. If you read only one article on biotech patent litigation, this is the one.

    Just read it.

  3. Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response to Our Divided Patent System
    • #3 was response to this paper: Our Divided Patent System
    • Conclusion:

      ... a significant number of the biotech litigations identified in the Study resulted in favorable outcomes for the patent owner. In cases where the patent owner did not prevail, more often than not, it was not because the patent was invalid, but rather because it simply did not cover the allegedly infringing product or activity. In fact, in some cases, it looks like the non-prevailing patent owner was simply attempting to overreach with its patent. ...

      Two important types of patented technologies, however, clearly did not do well in the biotech patent litigations identified in the Study. One of these is monoclonal antibody therapeutics.

      Molecular diagnostics is another important as- pect of biotechnology that might not be amenable to effective patent protection under the current state of patent law.

  4. Biotech & Pharmaceutical Patent Cases: 2015 Year in Review by Fish & Richardson.

 Specific Cases

  1. Idenix vs. Gilead: District Court Exercises Discretion to Deny Enhanced Damages [ Sanjeev Mahanta, Ph.D., J.D.@IPWatchdog]Dr. Ray Schinazi (on both Idenix and Pharmasset) shared Idenix's discovery with Pharmasset. Then Pharmasset scientists built a prodrug on top of a derivative from Idenix's idea.

    the Supreme Court reiterated that “patent law reflects a careful balance between the need to promote innovation through patent protection, and the importance of facilitating the imitation and refinement through imitation that are necessary to invention itself and the very lifeblood of a competitive economy.”

  2. Arbutus vs Acuitas: Dispute over sublicensing of ABUS's LNP delivery tech.
    Injuction ruling 02.07.2017

    Settled right before trial: Press Release

    “This settlement terminates Acuitas’ right to use or sublicense our LNP technology going forward, making permanent the effect of the Court’s prior injunction,” said Dr. Mark J Murray, Arbutus President and CEO. “Arbutus LNP represents the most clinically validated delivery technology suitable for RNAi, mRNA therapeutics and gene editing applications. With the settlement of the Acuitas litigation, Arbutus has now consolidated its LNP intellectual property estate. This is a major milestone which establishes Arbutus as the owner and only source of this industry-leading technology platform with the ability to develop a full range of applications.”

How to Read Patent


Challenging Patent Validity in the USPTO: Strategic Considerations in View of the USPTO’s Final Rules by Fish & Richardson