On 21 November 2017, the German Federal Patent Court decided about a license fee for the HIV-Drug Isentress for which it has granted a compulsory license in 2016.

Background of the Case

In 2016, Shionogi & Company Ltd, owner of the European Patent EP 1 422 218, accused Merck & Co. of violating this patent by selling the HIV drug Isentress. The drug has been generating worldwide sales of around USD 1.5 billion annually since 2012. Shionogi filed a lawsuit with the Regional Court of Düsseldorf. Merck opposed by applying for a compulsory license with the German Federal Patent Court and also requested a provisional allowance order under section 85 of the German Patent Act. In a preliminary ruling, the German Federal Patent Court ordered Shionogi to grant a compulsory license to Merck & Co. The German Federal Patent Court based its decision on the fact that Merck & Co. had made a license offer to Shionogi for a worldwide license and that there is a substantial public interest due to the paramount importance of the drug for patients with HIV infections – please see our previous post on this decision for more information (https://www.allaboutipblog.com/2016/11/german-federal-patent-court-grants-compulsory-license-on-hiv-drug-patent/). This preliminary ruling was confirmed by the German Federal Court of Justice in July 2017.

The Ruling

The German Federal Patent Court now decided about the amount of the compulsory license fee and held that Merck & Co. has to pay a license fee of 4% on the sales of the drug Isentress. The written reasons for this decision have not yet been published.

Infection And Disease ControlOn 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity.

Under Article 3 of the Orphan Regulation, an orphan designation is subject to the following two conditions:

  • The product is intended for the diagnosis, prevention or treatment of a rare condition (“prevalence criterion”), or the marketing of the product intended for the diagnosis, prevention or treatment of a life-threatening or serious condition would not generate sufficient return to cover the investment made (“financial criterion”); and
  • There is no satisfactory treatment for the condition in the EU, or if there is, the future medicinal product will be of significant benefit to patients affected by that condition (“significant benefit”).

The Notice, inter alia, specifies that a “significant benefit” may no longer be based on a possible increased availability due to shortages of existing authorized products; or a new pharmaceutical form, a new strength or a new route of administration, unless it brings a major contribution to patient care. The Notice further reiterates that treatments for communicable diseases with very low or close-to-zero prevalence in the EU, such as the Ebola and the Zika virus diseases, are also eligible for orphan designation in the EU. The eligibility is based on the risk of EU residents becoming affected by the disease.

Click here to read the full Mayer Brown Legal Update on the Commission’s Notice.

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.

HomeopathyOn 15 November 2016, the US Federal Trade Commission (“FTC” or the “Commission”) issued an “Enforcement Policy Statement” (“Policy Statement”) to provide guidance about its enforcement policy on marketing claims for over-the-counter (“OTC”) homeopathic remedies. The FTC concluded that marketing claims that OTC homeopathic products have a therapeutic effect (beyond placebo) lack a scientific basis. Consumers were therefore likely to be deceived by labels that do not disclose the lack of “adequately substantiated evidence” that ‎those products have the claimed treatment effects.

Unlike, for example, US Food and Drug Administration (FDA) regulations that govern prescription drug labels, the FTC’s Policy Statement does not constitute binding regulatory action. However, it lays out the governing principles that the FTC will apply in evaluating whether OTC homeopathic advertising and labeling is deceptive.

The Concept of Homeopathy

The concept of homeopathy was developed at the beginning of the 19th century by German physician and pharmacist Samuel Hahnemann. The therapeutic method is based on the belief that disease symptoms can be treated by minute doses of substances that are capable of producing in healthy people symptoms like those of the disease. In its Policy Statement, the FTC was especially critical of the fact that many homeopathic remedies were diluted to such an extent that they no longer contained detectable levels of active ingredient. Still, the homeopathic drug market has become a multimillion dollar industry with many faithful adherents.

The Commission’s Reasoning

The Policy Statement was informed by a one-day public workshop and related public comments on how homeopathic remedies are marketed to consumers. In its “Staff Report on the Homeopathic Medicine & Advertising Workshop,” the Commission concluded that efficacy claims for traditional OTC homeopathic products were not valid. They were only supported by theories that are not accepted by most modern medical experts and provings that did not constitute “competent and reliable scientific evidence” that these products have the claimed therapeutic effects. The FTC further concluded that no convincing reasons were brought forward as to “why […] OTC homeopathic drugs should not be held to the same truth […] as other products claiming health benefits.”

Notably, the Commission stressed the inherent contradiction that underlies the assertion that a product is effective while at the same time disclosing that there is no scientific evidence for the efficacy claim. Therefore, depending on how the disclaimers were presented, many of them could be insufficient to adequately convey the “extremely limited nature of the health claim being asserted.”

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.

Condoms and contraceptive pills to practice safe sexOn 31 August 2016, the German Federal Patent Court issued a compulsory license under a patent that protects an HIV drug to affiliates of Merck & Co. (Case 3 LiQ 1/16). It was only the second time in the history of the court that a compulsory license has been granted and the first time that such license was granted in an emergency procedure. The Federal Patent Court’s first decision to grant a compulsory license dates back to 1991 (Case 3 Li 1/90) and did not survive appeal to the Federal Court of Justice (Case X ZR 26/92).

The Facts of the Case

The European patent EP 1 422 218, which is owned by Japanese company Shionogi & Company Ltd., protects an integrase inhibitor that is used in the treatment of HIV infections. A medicinal product that arguably makes use of the patented invention has been marketed for a couple of years now by Merck & Co. in the United States and Europe under the trade name of Isentress. The active substance in Isentress, Raltegravir, prevents the integration of the HIV genome into the host DNA and, thus, prevents the HI-Virus from multiplying. Raltegravir has shown a relatively high tolerability among patients and has proven effective against multidrug-resistant viruses.

In 2015, the German Merck & Co. subsidiary MSD Sharp & Dohme GmbH was sued for an injunction for patent infringement by Shionogi in the Regional Court of Düsseldorf (Case 4c O 48/15). In response, Merck & Co. tried to obtain a worldwide license under the patent. Shionogi rejected the offer and MSD brought an action for issuance of a compulsory license before the Federal Patent Court and, at the same time, requested a provisional allowance order under section 85 of the German Patent Act.

Pursuant to section 24 para. 1 of the German Patent Act, a compulsory license shall only be granted by the Federal Patent Court when a license seeker has unsuccessfully attempted to obtain an economically reasonable license from the patent owner, and when the public interest calls for the grant of a compulsory license.

The Ruling

On the basis of an expert opinion, the Federal Patent Court reached the conclusion that there was a significant medical need among certain HIV-infected and/or AIDS patients for Isentress, and that these patients could not resort to other currently available integrase inhibitors without severe health risks. This was in particular true for pregnant women, infants and long-time HIV patients. With an effective reduction of the viral load, the risk of infection of third persons could also be reduced. A public interest for the grant of a compulsory license was, therefore, present. The court did not follow Shionogi’s argument that Merck & Co. had not made a serious effort to obtain a license.

However, the ruling is only provisional. The main proceeding is still pending before the Federal Patent Court. Shionogi might also be able to appeal the court’s main decision to the Federal Court of Justice.

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.

PillsOn 14 June 2016, the German Federal Court of Justice (X ZR 29/15 “Pemetrexed”) confirmed prior decisions in which it held that patent infringement under the doctrine of equivalents can, in principle, not be assumed, if the patent discloses various ways that a certain technical result can be achieved, but only one of those possibilities has found its way into the claims.

The Court held that if the wording of the claims is narrower than what would have been necessary—considering the technical contribution of the patented invention to the prior art— competitors and other interested parties can rely on the applicant’s carefully chosen words. The patent holder is not allowed to subsequently claim protection for something that he deliberately chose not to protect. According to the Court, this rule shall even apply when a person skilled in the art realizes that the effects of the invention go beyond the technical matter for which the applicant sought protection in the claims.

Also, embodiments that are not explicitly disclosed but that can easily be identified by a person skilled in the art from the specification are, in principle, excluded from equivalent patent protection. The latter, however, ultimately depends on the reader’s perception of the patent document.

However, this principle, like every other in the field of IP law, has its limits. It shall only apply to circumstances where the patent document (explicitly or inherently) discloses more than one embodiment. An extension of this principle to embodiments that were available to a person skilled in the art only through a vague indication in the specification would, in the eyes of the Court, go too far because the availability of equivalent embodiments is a necessary precondition for a finding of infringement under the doctrine of equivalents. If these embodiments were also excluded from the scope of protection one would never be able to establish infringement by equivalence.

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.