In an important and potentially far-reaching ruling for the biotechnology and pharmaceutical industries, the European Court of Justice ruled today that stem cell processes which require the use and prior destruction of human embryos are not patentable. The ruling is expected to have substantial impact on stem cell research in Europe and on patent filing strategies for companies interested in obtaining patents for processes and methods related to stem cell research.

The opinion in Oliver Brüstle v. Greenpeace e.V. results from an appeal brought by a German stem cell researcher. Brüstle first obtained a patent in 1997 on a process using precursor cells obtained from human embryo stem cells to treat certain neurological diseases. Greenpeace later succeeded in annulling the Brüstle patent in a German court. On appeal, the German federal court of justice asked the ECJ to consider whether uses of human embryos for industrial or commercial purposes is within the legal protection available to biotechnological inventions.

The ECJ’s ruling means that under EU law, stem cell processes resulting from human embryo research, and the use of human embryos for the purposes of scientific research, are generally not patentable. It is not yet clear, however, what impact the decision will have on biotechnology patent practice across Europe. While European Patent Office practice also mandates that human embryonic stem cell inventions are not patentable, the EPO is effectively an independent body not bound by EU law – and many EPO member countries are not EU member states. It also remains to be seen how national patent offices will interpret the ECJ decision.

One reason for that is that the ECJ declined to be specific – and significantly, the ECJ did not rule that Brüstle’s patent was invalid. The ECJ left open the issue of whether stem cells obtained at a particular stage were included within the concept of a human embryo, since the description of the stem cell process in the Brüstle patent does not specifically refer to the use of human embryos. Therefore, it remains for each national patent office to interpret the ECJ decision and decide how it should be followed. The ECJ decision can also be interpreted narrowly to limit the prohibition on patentability to processes resulting from the destruction of human embryos – meaning that it is not clear what, if any, the ruling will have on stem cell research within the EU, since alternative methods for obtaining stem cells without the use or destruction of human embryos would not be affected by the ECJ decision.

Regardless, the biotechnology and pharmaceutical industries are likely to feel a wide impact. It will now be much more difficult to obtain patents on processes for, and by extension therapeutics from, stem cell research from human embryos in the European Union.  And the ruling may significantly alter international intellectual property protection strategies, as patent applicants consider how to maximize patent protection to obtain a return on research investment.  Applicants should therefore carefully analyze patentability in each European country and consider filing in each jurisdiction directly, outside of the EPO filing framework, while national patent laws interpret the specific impact of the ruling on EU law.

Last week saw several interesting developments in the worldwide patent war being fought by technology giants Samsung and Apple. The two companies are doing battle on multiple fronts across the globe, each asserting patents against the other covering various aspects of their respective mobile devices.  Events of this week show that although it’s still too early to gauge who will emerge victorious as momentum swings back and forth for each side, it may be that Apple is slowly gaining the upper hand.

 The week began in Australia, with the Federal Court granting an injunction banning sales of certain Samsung tablets accused of infringing Apple’s Australian patents. Apple initiated the Australian suit against Samsung earlier this year, and the request for injunction followed with arguments completed in early October. The injunction means that Samsung’s devices won’t be available to Australian customers until it resolves its patent infringement claims with Apple, and will be a significant blow to Samsung’s attempt to establish a share of the Australian market. Samsung has fired back however, filing its own claims of patent infringement in September and asserting that Apple has violated Samsung’s intellectual property rights in seven Australian patents.

The middle of the week saw the United States courts taking center stage. A San Francisco federal district court heard arguments on Apple’s injunction request – and although no ruling has yet been issued, the court’s comments indicate that it may throw Samsung a lifeline. Samsung argued that to get the injunction, Apple must show that Samsung infringes the patents in question and that the patents are valid – and the court commented that although there was a likelihood of infringement, it thought that Apple would have difficult establishing the patents’ validity.

Finally, the two parties’ dispute in the Netherlands saw an important advantage going back to Apple. Apple had obtained an injunction against Samsung in August, and Samsung fired back with its own claims of infringement and request for an injunction. The Dutch court hearing the dispute turned down Samsung’s injunction request on certain Apple products, and rejected claims that they infringe on Samsung’s patents.

While developments intensify in these countries, other fronts have recently been opened as the global fight widens and as new products are brought to market. Samsung recently sued Apple in France and Italy, attempting to ban sales of Apple’s latest mobile device, the iPhone 4S, in those countries.  Apple also filed a lawsuit against Samsung in Japan in September, and cases in the United Kingdom and other countries are still pending.

The growing volume of patent litigation therefore shows no signs of subsiding. As mobile devices such as smartphones and tablet computers proliferate, and the fight for market share for those products intensifies, so is the fight for control in the courts based on the parties’ intellectual property rights.  The dispute between Samsung and Apple, and several others between various entities in the mobile device marketplace for both hardware and operating system technology, highlights the importance that investment in intellectual property rights can have as a tool to establish, defend, and improve a market position.  And it also highlights what may be a bigger battle looming – between providers of operating systems running these mobile devices, instead of just the devices themselves.

The United States, together with several other industrialized nations, has signed a major international treaty designed to enhance global protections against counterfeiting and intellectual property piracy. The treaty, known as the Anti-Counterfeiting Trade Agreement, or ACTA for short, requires signatory nations to enact aggressive intellectual property protection legislation similar to that already in place in the United States. Significantly, the agreement was signed by the U.S. government without Congressional debate or approval.

ACTA has been in the works for more than three years. The agreement was signed recently at a Tokyo signing ceremony by Australia, Canada, Japan, Morocco, New Zealand, Singapore, and South Korea, as well as the United States, and significantly tightens global protections against intellectual property infringement, particularly with respect to copyrights. Three other participants in the negotiating process – the European Union, Mexico, and Switzerland – have not yet signed the agreement. The EU’s absence is notable – despite being negotiated by the European Commission on behalf of EU member states, the agreement itself must still be approved by the European Parliament – and the EU has not yet completed its internal procedures authorizing signature.

ACTA is a voluntary agreement that provides a mechanism for the parties involved to collaborate on increasing effective intellectual property rights enforcement.  ACTA is replete with provisions concerning enhanced criminal enforcement. For example, it requires parties to provide criminal penalties and procedures for willful trademark counterfeiting or copyright or related rights piracy on a commercial scale , and applies criminal penalties to willful importation and domestic use of labels or packaging using an unauthorized trademark, as well as unauthorized copying of cinematographic works from a performance in a movie theater. Countries must include imprisonment and heavy fines among the penalties for such activities.

While ACTA is heavily weighted in favor of rights holders and has received significant support from industry groups representing trademark and copyright owners, critics have also made their voices heard. One significant concern asserted is that the agreement, which was negotiated in secret, improperly and unfairly circumvents existing and accepted international negotiating protocols such as TRIPS and WIPO. Critics have also raised concerns about whether information privacy has been adequately considered. For example, among the many provisions requiring enhanced criminal enforcement, ACTA empowers signatory nations to order an online service provider to disclose information sufficient to identify a subscriber whose account was allegedly used for infringement.

In the United States, it remains to be seen whether ACTA will require any changes to existing intellectual property laws or creates any new international obligations. That’s because one significant issue drawing attention is whether public and congressional debate is needed before entering into an international agreement such as ACTA. At least one member of Congress has objected to the unilateral signing of the agreement, asserting that because Congress has plenary powers to regulate foreign commerce and protect intellectual property, the U.S. President does not have constitutional authority to unilaterally enter into such binding international treaties. If a constitutional challenge is brought regarding ACTA, the United States Trade Representative (which is a part of the executive branch and negotiated the treaty on behalf of the U.S.) may be required to provide clarity as to precisely what responsibilities have been imposed by this agreement.

Owners of trademarks and well-known brand and personal names finally have a new intellectual property tool to protect their rights in one of the European Union’s biggest markets. In July 2011, Italy implemented comprehensive trademark opposition procedures to allow rights holders to challenge third parties seeking to usurp those rights.

The new procedures apply to both native Italian trademark applications and Italian extensions of international trademark applications. Oppositions are now available against Italian trademark applications filed as on May 2011, as well as territorial designations of international marks regardless of their date of registration that have been published in the World Intellectual Property Organization (WIPO) Official Gazette as of July 2011.

The new Italian procedures impose time limits on those wishing to initiate opposition proceedings that triggered by dates of publication. For example, oppositions may be brought against Italian trademark applications no later than 3 months from the date of publication in Italy.  Oppositions to local designations of international trademark registrations are possible no later than 3 months from the first day of the month following publication in WIPO’s Official Gazette.

The new procedures should significantly assist intellectual property rights holders protect their investment in trademarks and brand development. Those who have existing trademark rights may institute opposition proceedings against applications for marks that are either identical to that of the application to be opposed and which covering identical products, or that are so similar that a likelihood of confusion exists. Significantly image rights and personal names are also included in the protection available from opposition proceedings to provide recourse where use of the image or name by a third party might injure the associated reputation associated.

Italy’s new opposition procedures therefore come as a welcome benefit, as they offer an alternative to expensive and lengthy judicial cancellation proceedings. In addition to lower costs for the parties and strict time limits that require a decision within 24 months, the procedures include a mandatory initial cooling-off period of two months immediately following official notice that opposition proceedings have been requested. The procedures are therefore encouraged the parties to meet and settle their differences quickly before beginning adversarial proceedings.

While Italy’s move harmonizes options for trademark opposition with regular international practice, it is unclear whether the new procedures provide rights holders with full protection compared to other countries.  Italy’s rules appear to require that an opposition be based on an existing application or registration. Whether it is possible to base such an opposition on trademarks that have been in use but never registered, such as for brand names or logos for which no registration was ever attempted, remains to be seen. Those who have rights based on previous use alone may still need to resort to the Italian courts to challenge later-filed trademark applications or international registrations.

Efforts to create a single patent valid across all of Europe are nothing new, yet patent protection is presently only available by validating a patent granted by the European Patent Office (EPO) in each individual member country. Proposals to change this have been gathering steam, but court cases brought by two different countries may threaten any recent momentum.

Italy and Spain applied to the European Court of Justice (ECJ) to rescind a March 2011 decision that would make it easier to create a single mechanism for granting unitary patent protection by specifically authorizing enhanced cooperation among EU member countries. The ECJ decision, known as Council Decision 2011/167/EU, is notable for its approach to further prospects for this purpose. The Council Decision follows provisions under the EU’s Lisbon Treaty that provide for “enhanced cooperation” as a workaround to a failure to reach consensus during member state negotiations. The Council Decision results from frustration of certain EU member states at not being able to reach unanimity regarding EU-wide patent protection and reflects their desire to establish rules between themselves on the basis of existing proposals they support.

Recent attempts to make headway on the unitary patent protection issue were derailed by a lack of agreement on language and translation arrangements. Previous negotiations aimed to have patent procedures conducted in one of three languages (French, German, and English), which would considerably reduce the costs of obtaining patent protection in Europe. This, however, excludes all other languages among the EU member countries. Several countries objected, concluding that it would be give German and French competitors competitive advantages.

Spain and Italy brought their ECJ actions to object to the Council Decision as unlawful and likely to distort competition within the European Union. Both countries asserted that the conditions for invoking the Lisbon Treaty’s “enhanced cooperation” provisions were not fully met. Spain further argued that the Council Decision was merely a mechanism to avoid negotiating with member states instead of promoting integration of all member states, and therefore a misuse of powers. Deadlines for observations to the ECJ on the issues presented will pass in September, after which the ECJ will conduct hearings on the two cases.

Officials have long sought to implement unified mechanisms that make it easier to both obtain patent protection and enforce patent rights in multiple countries. Among the many suggested benefits of such proposals are reductions in costs to patent applicants. Present law allows applicants to pursue patent protection either in each country individually or through a validation procedure at the EPO. Applicants using the EPO must still ultimately register their validations in each country. Regardless of which of those two options are chosen, patent applicants must pay registration fees in each desired country, and often must pay for translations of patents into local languages.

A separate framework for an EU-wide dispute mechanism for enforcement of patent rights also presents problems, since patent rights holders must initiate and prosecute infringement actions in each country where a patent is registered. The result is an uneven approach that requires court cases in each country – and which is subject to local procedural rules and the potential for inconsistent decisions across multiple jurisdictions.

The cases filed by Italy and Spain highlight that obstacles remain to any significant progress towards unitary patent protection. The ECJ’s attempt to circumvent the language and translation concerns of some countries will likely further crystallize member state positions, rather than lead to any real consensus on the issues. Instead, the ECJ cases may only serve to further frustrate patent applicants hopeful for improvements that make it easier to patent their inventions in Europe.

In the global explosion in intellectual property litigation over mobile device technology, attention has turned to disputes between Apple and Samsung over their respective mobile product lines.  In their worldwide IP clash, the two companies have lawsuits pending against each other in jurisdictions around the world. The resulting international battles highlight the importance of a global intellectual property protection strategy around products expected to have significant cross-border appeal. Recent activity shows that a careful consideration of domestic and international IP laws may generate significant advantages depending on the country where enforcement is sought.

For example, Apple’s European litigation strategy seems to be focused in part on a clever plan for enforcing IP rights in the European Union based on a trademark-related Community design registration (No. 000181607-0001) it obtained in February 2010. A Community design registration is granted by the EU’s Office of Harmonization for the Internal Market, and confers rights across the whole of the European Union with a single registration. That means that a court decision, including an injunction, in one EU country regarding a violation of a design registration should apply in all EU countries. This is an inexpensive way to gain a huge advantage with one decision applying in many different markets – contrast this with patents in Europe, which must be conferred by and enforced in each individual country. Therefore, while attempts have made to unify patent grant and enforcement procedures across Europe, the Community design registration presents a much more attractive enforcement paradigm.

This has played itself out with injunctions in both the Netherlands and in Düsseldorf, Germany, both of which are new fronts recently opened in the firms’ global IP clash. The Düsseldorf lawsuit, filed by Apple on August 4, centered primarily on design registration No. 000181607-0001 and resulted in an injunction issued shortly thereafter. The injunction ordered a stop to the sale of certain tablet computers, and applied across the entire European Union. In the Netherlands, meanwhile, Apple succeeded in getting an injunction against the sale of certain mobile phones based on a separate lawsuit that sought damages for infringement of patents, copyrights, and the same community design registration.

Because a Community design registration can be obtained quickly and without much substantive validity analysis, Apple gained the upper hand in its European litigation by taking advantage of court procedures in countries that easily grant injunctions based on presumed validity. Despite the initial success achieved by Apple, however, subsequent decisions in both the Netherlands and Germany may indicate that more scrutiny will be given to whether the Community design registration can be used for such far-reaching results as an EU-wide injunction. Significantly, Samsung later succeeded in modifying the Düsseldorf injunction to apply only to tablet devices in Germany, and the court will revisit the issue in a hearing on September 9. Furthermore, the injunction in the Netherlands applies only to the possible infringement of an Apple operating system-related patent, and therefore, to sales only in the Netherlands, meaning that EU-wide sales of Samsung mobile phones are not directly prohibited. The Netherlands injunction also applies only to certain mobile phones.

Regardless of how the various injunctions are ultimately applied and how the litigation is resolved, the Apple/Samsung dispute shows the importance of considering all domestic and international IP protection possibilities. While Samsung appears to have tilted the momentum slightly back in its direction, Apple’s use of the Community design registration generated a significant initial litigation advantage and allowed it to stretch the mobile device IP war across the globe, substantially raising the stakes for competitors.