Panel speakers were dina kallay ericsson, dirk weiler etsinokia, tim syrett wilmerhale, carlos aboim licks, and my humble self. The landmark decision orangebook standard 1 of the german federal court of justice fcj confirms that a defendant sued for the infringement of a standard essential patent sep patents protecting industry standard technologies can rely on an antitrust defence frand defence against claims for injunctive relief, if the plaintiff refuses to grant a licence under frand terms. Standard essential patents and court injunctions in the high. On september 25, 2018, wipo launched the patent information initiative for medicines, or patinformed, in collaboration with the international federation of pharmaceutical manufacturers and associations. The raaymakers and lagadec patent were included in the pool administered by philips.
This chapter addresses the interpretation of the term essential within sdo patent policies, focusing both on policy language and variants, as well. A number of industries, such as telecoms, it and automotive heavily rely on standards. Standards organizations, therefore, often require members disclose and grant licenses to their patents and pending patent applications that cover a standard that the organization is developing. Jan 28, 20 since the orange book decision down in 2009, there have been a number of patent infringement cases involving standard essential patents which the defendant invoked the orange book defense at some point to varying degrees of success. This is an obligation under competition law, to ensure that the agreement is lawful. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and. European court of justices judgment in case c170 huawei. Huawei v zte no more need to look at the orange book in. The court, which hears more patent infringement cases than any other court in europe though most of the german patent cases. The dissent accurately the dissent accurately stated the net result of the majoritys holding, namely that a patent can be listed in the orange book as erroneously covering. The orange book provides information on patents for drugs that the fda has approved for public use, which makes it much easier for generic drug companies to identify whether or not the drug they wish to manufacture is already patented and fdaapproved. Apr 05, 2012 the german orange book standard approach to standard essential patents denies injunctions only if a variety of criteria are met, and the legal logic is not equity fairness and reasonableness. Kzr3906 involved a patent that was allegedly essential to standards covering recordable compact discs, or cdrs.
The essential patent llc intellectual property law firm welcomes you to the essential patent blog. Standard essential patents and court injunctions in the. The standardsetting process and injunctive relief to enforce patent rights 2. Kzr3906 involved a patent that was allegedly essential to standards covering recordable. Owners of patents essential to using the standardstandard essential patents or sepsmay opportunistically target nonlicensed implementers with patent infringement suits and reinforce their royalty demands with 1. Standard essential patents would be granted under eu antitrust law. Mar 21, 20 the court found zte to infringe this patent, which huawei had declared essential to the 4glte cellular telecommunications standard, and was unconvinced that zte would achieve its invalidation zte opposed the recent grant of this patent, but in february the european patent office rejected ztes opposition in a first, appealable, decision. Bundesgerichtshof, bgh on the interaction between patent law and technical standards, and more generally. German court refers huaweizte standardessential patent. Approved drug products with therapeutic equivalence. Since the orange book decision down in 2009, there have been a number of patent infringement cases involving standardessential patents which the defendant invoked the orange book defense at some point to varying degrees of success. Huawei v zte no more need to look at the orange book in sep.
It is natural that, in those circumstances, the patent owner will have greater negotiating power than in the case of an sep owner. Court orders orange book patent delisting in nuedexta. Standard essential patents, frand commitments and competition law. Historically, most sep issues were relegated to theoretical discussions in academic literature or conference presentations. Patent pooling arrangements and mandatory package licenses. Standard essential patents, trolls, and the smartphone. The nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or amend the patent information in accordance with paragraph f2 of this section, provide a narrative description no more than 250 words of the nda. The interface between eu competition law and standard essential patents from orangebookstandard to the huawei case bjorn lundqvist european competition journal. But once a patent becomes essential to a standard, the patentees bargaining power surges because a prospective licensee has no alternative to licensing the patent. Once a standard has been adopted, standardsetting organisations usually require owners of patents found to be essential to the stan. Sep enforcement disputes beyond the waters edge wilmerhale. It is natural that, in those circumstances, the patent owner will have greater negotiating power than. Frand commitments, injunctions and the smartphone wars. Often, it is used more specifically to refer to patents owned by companies that work together to create a standard, and agree to license their essential patents to other people who are implementing the standard.
Dec, 2010 princo alleges patent misuse for unlawful tying of essential and non essential patents. The case law in europe prior to those decisions was mainly focused on the german case law from orange book standard which provided ip holders great leverage due to the almost automatic granting of injunctions against infringers. This blog was started in response to increased interest and litigation surrounding standard essential patents seps. The courts in germany which has recently become a hotbed for patent litigation have developed a unique procedure for dealing with the assertion of standard essential patents. The inclusion of the lagadec patent in the package led to princos allegation of patent misuse through unlawful tying. Zte case that may, indirectly, have unprecedented impact on all standardessential patent sep enforcement in the european union. An essential patent or standardessential patent sep is a patent that claims an invention that. Nokia involving 3g cellular essential patent motorola mobility v. The interface between eu competition law and standard essential. In other words, they must 1 claim a small molecule drug product approved or marketed anywhere in the world and 2 not fall into one of the categories excluded in the us orange book. Compulsory licensing of standardessential patents and.
German court system favorable for patent litigation pcworld. In 2009 the federal court of justice issued its landmark orange book standard decision kzr 3906. A patent might not be listed for in the orange book because either a its a process patent. Princo contended that philips package licensing constituted misuse by unlawfully tying licenses for patents nonessential to the orange book standard with licenses for patents. Just like germanys disastrous orangebookstandard approach to standardessential patent sep injunctions never got fixed within germany until the european commission and, especially, the court of justice of the eu set the record straight, the wider problem of automatic patent injunctions might also be solved through litigationnot. In japan, on february 28 20, the tokyo district court made the first decision on whether the enforcement of sep with the patentees frand declaration would be limited. Frand defence put on trial before european court of justice. Patent use codes, the orange book and seciton viii. Apr 27, 2017 accordingly, a key element of sdo disclosure and licensing polices is how patents or patent claims are classified as essential to a standard, and what essentiality entails in practice. Kzr 3906 is a decision issued on may 6, 2009 by the federal court of justice of germany german. That cost would be a measure of the value of the patent. German court refers huaweizte standardessential patent case. Samsung in relation to dvd standard essential patent pools.
Smartphone patent litigation and standard essential. Industry standards in ictindustries are minefields, if they are covered by essential patents, covering technologies that must be used when building a standard. The obligation means that a patent owner must offer frand terms, and may not seek an injunction against a user that is willing to accept frand. The court held that a defendant, accused of patent infringement and who was not able to. Greenorangered, the german orangebook decision is putting. Bundesgerichtshof federal court of justice of 6 may 2009 case no. The german orangebookstandard approach to standardessential patents denies injunctions only if a variety of criteria are met, and the legal logic is not equity fairness and reasonableness. Smartphone litigation and standard essential patents. Princo alleges patent misuse for unlawful tying of essential and nonessential patents. Accordingly, a key element of sdo disclosure and licensing polices is how patents or patent claims are classified as essential to a standard, and what essentiality entails in. However, the elements of the orange book frand defense are onerous. Shapiro 2000, lemley 2002, farrell et al 2007 argue that seps in particular cause a patent holdup problem via the threat of injunction, allowing these patent owners to derive supracompetitive rents. Orange book standardthe framework for the frand defense 9 b lower court application of orange book standard 10.
Oliver heinisch is a partner in the antitrust and competition practice group in the firms london office. Apr 01, 2019 the nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or amend the patent information in accordance with paragraph f2 of this section, provide a narrative description no more than 250 words of the nda. Sep 06, 2017 nokias licensing business has been in the news over the last few months after apple agreed to pay the company 1. The evolving standard for patent misuse in patent pools. Focus on technology standards and standard essential patents seps.
The eu court of justice judgment in huawei v zte important. When companies agree on a standard, they agree to licence patents that are essential for that standard on fair, reasonable and nondiscriminatory frand terms. Cross licenses, patent pools, and standardsetting, forthcoming innovation policy and the economy, volume i, mit press, 2001. Nov 21, 2017 the orange book also displays the dates on which drugs were submitted for patent protection and the dates on which patents became effective. Commission decision of 29 april 2014, motorolastandard essential patents, oj c 3446 of 2 october 2014, case c 170 huawei technologies v.
This blog was started in response to increased interest and litigation surrounding standardessential patents seps. Germany, including on frand licensing and orange book standard case law ipcomm v htc and others honors. Orange book standard decision which will be outlined under b. In a landmark judgment rendered july 16, 2015, the european court of justice court has clarified when a holder of a standard essential patent sep who has committed to the standard setting organization to grant licences to all implementers of the standard on fair, reasonable and nondiscriminatory terms frand is prohibited from seeking a court. Accordingly, a focus of the appeal was whether the lagadec patent was essential to the orange book standard.
Patinformed is the first free, open access database that directly links granted patents to marketed medicines across the globe. In that case, involving ofirmev acetaminophen injection nda no. Conversely, patents that are not essential to such standards need not be licensed on reasonable terms, and in theory may be withheld entirely from the market. The orange book standard uses the analog raaymakers patents, which are essential to disc manufacturing under the standard. Note that this information is only available for those drugs for which patents were obtained on or after 20.
Bundesgerichtshof, bgh on the interaction between patent law and technical standards, and more generally between intellectual property law and competition law. See commission decision of 29 april 2014, samsungstandard essential patents, oj c 3508 of 4 october 2010. Patent use codes, the orange book and seciton viii statements. Court of appeals for the federal circuit, will consist of the following sessions. In europe and the us, numerous decisions regarding frand terms and the enforceability of standard essential patent sep have been issued. Just like germanys disastrous orange book standard approach to standard essential patent sep injunctions never got fixed within germany until the european commission and, especially, the court of justice of the eu set the record straight, the wider problem of automatic patent injunctions might also be solved through litigationnot. Named for a 2009 decision by the federal supreme court of germany, this is commonly known as the orange book defense or procedure or sometimes as the dolo agit or good faith defense. Htc on their antitrust defence against assertion of standard essential patents in the patent court of mannheim germany, including on frand licensing and orange book standard case law ipcomm v htc and others. For generic drug companies, the orange book provides notice that there are patents out there covering fdaapproved drugs. The panel focused on standard essential patents seps and frand fair, reasonable and nondiscriminatory licensing commitments regarding such patents.
Standards organizations, therefore, often require members disclose and grant licenses to their patents and pending patent applications that cover a standard that the organization is developing if a standards organization fails to get. Standard essential patents, injunctions, and abuse of. Prohibitory injunction may constitute the abuse of a dominant position 05. Smartphone patent litigation and standard essential patents. Princo asserted patent misuse as a defense to philips claims of infringement.
Dec 06, 2017 against this background, it makes an evident difference whether your standard essential patent reads on the core of the standard. Nokias licensing business has been in the news over the last few months after apple agreed to pay the company 1. The landmark decision orangebook standard 1 of the german federal court of justice fcj confirms that a defendant sued for the infringement of a standard essential patent sep patents protecting industry standard technologies can rely on an antitrust defence frand defence against claims for injunctive relief, if the plaintiff refuses to grant a licence. For any drugs patented before 20, the interested party must reach out to the fda for exact. These technical standards were set forth in a document known as the orange book not to be confused with the orange book relating to pharmaceuticals that is maintained by the u. Against this background, it makes an evident difference whether your standardessential patent reads on the core of the standard. Essentiality and standardsessential patents by jorge l. A success story, landslide magazine marchapril 2016 for a number of years, the smartphone wars have been blamed, at least in part, for causing a broken and chaotic patent system. It was just a few months ago that we posted on what might have been the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the orange book and that does not concern a patent use code.
Frequently asked questions on patents and exclusivity fda. Standardsessential patents and injunctive relief table of contents page i. An essential patent or standardessential patent sep is a patent that claims an invention that must be used to comply with a technical standard. The short answer is that an essential patent is a patent that covers technology required to implement a technology standard. Qualifying patents must meet what patinformed calls a global orange book standard. Standard essential patents, trolls, and the smartphone wars. Standard essential patents, antitrust and market power. Jmls program on standard essential patents the program, which will be presented by graham bell of cubicibuc ltd. Nov 19, 2015 the ecj rules on standardessential patents.
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