Posts by: Niklas Mattsson | (9) posts

Unitary SPCs in Europe after all?

As readers of this blog know, we at Awapatent are actively following the exciting developments in the creation of a unitary patent system in Europe. It will be possible to obtain European patents with unitary effect in 25 countries, and we’ll have a new Unified Patent Court (UPC) for centralized patent disputes. We look forward to the start of the new system, and will be prepared to act from day one. Right now, those of us with a focus on the biotech and pharma industries are looking closely at how the new system applies to the possibility to prolong protection beyond the normal life span of a patent, through Supplementary Protection Certificates (SPCs). SPCs are available in the EU for medicinal and plant protection products.

SPCs for pharmaceuticals are arguably the most valuable intellectual assets, at least in terms of the value per individual registered right. In the EU, SPCs are national, and must be applied for in each country separately. Against this background, one would have expected the new unitary patent legislation to take account also of SPCs, and to create a unitary SPC title. Unfortunately, even though there are provisions in the court agreement that bring national SPCs under the new jurisdiction, no unitary SPC is created. As a result, there will be a gap in the European law of SPCs, and substantial uncertainties regarding the interplay between unitary patents and national SPC rights.

Quite naturally, this situation is a concern to those industries that rely on SPCs to recoup their investments into new products. In a joint position paper from July 2015, the European industry organizations for human and veterinary medicine and crop protection called upon the EU Commission to urgently begin work on creating a unitary SPC. They also gave suggestions concerning what body would be responsible for granting such SPCs and how they may be litigated in the UPC. In a pleasing turn of events, it now seems like this call is going to be answered. In a strategy document from October 2015, the EU Commission stated that “the Commission will consider […] a recalibration of the patent and SPC regulatory framework in the EU, including […] a unitary SPC, which would enhance the value, transparency and legal certainty of the protection of medicines and plant protection products”. Recently, we received another sign that this process is underway, when the EU Commission put out a tender for a study of the current SPC system. The aim of this study is for example stated to be the creation of a starting point “for a future proposal by the Commission to create a European SPC title”.

The current SPC regime, while well-known to us, is full of inconsistencies, and is also applied differently in different countries. Just like the industry organizations in their position paper, we and our clients would very much welcome a unitary SPC and its likely positive effects on harmonization and predictability.

Niklas Mattsson, Partner and European Patent Attorney

Myriad patent claims on breast cancer genes invalidated by US Supreme Court

In a decision on 13 June, the highest court of the USA, the US Supreme Court, said the final word in the highly publicized “gene patent” case involving Myriad Genetics. The decision is available here. See our previous reports on this case here, here and here.

In brief, a group of plaintiffs wanted the courts to invalidate Myriad’s patents on the breast cancer susceptibility genes BRCA1 and BRCA2. The matter has been going through the various federal court instances since 2010, and is now finally settled.

The US Supreme Court, in their unanimous decision yesterday, held that claims to naturally occurring DNA are not allowable as a matter of principle. In other words, it is not a patentable invention to isolate such DNA, regardless of the effort involved or the practical benefits of these efforts. However, DNA that is further modified such that it is no longer identical to the DNA occurring in nature, is not barred from patentability.

The decision was somewhat expected, judging from the public discussion about the case during the last six months, and especially from the oral hearing in the Supreme Court on 15 April this year. This, however, does not mean that it will not have a great impact.

It is still too early to know the full consequences of the decision. It is, however, clear that the established legal landscape of 25 years or so, making DNA patents possible, has been radically altered, and that many thousands of granted patents on genes are now essentially worthless. In other words, any business depending on the exclusivity for a naturally occurring sequence will be adversely effected by the decision.

Apart from casting doubt on many settled expectations, the court decision also opens the door to future questions concerning the validity of patents to other naturally occurring molecules. What, for example, is the situation concerning naturally occurring proteins, such as hormones and enzymes? Many biopharmaceutical products in this category have been brought to the market based on patents for the products, patents motivated by their isolation and industrial application.

Another aspect of the case is that international harmonization of patent law, in particular between the US and the European Union, has suffered a setback. In the EU, the directive on legal protection of biotech inventions (98/44/EC) expressly permits, in Article 5(2), the kind of patents now prohibited in the US.

Niklas Mattsson, Partner and European Patent Attorney

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Breast cancer gene patents once again found valid by US appeals court

In the “Myriad case” an ongoing legal battle with many twists and turns, the Court of Appeals for the Federal Circuit, CAFC, has decided to once again uphold patent claims covering isolated human genes BRCA1 and BRCA2, owned at least partly by Myriad Genetics Inc in Utah, USA. The patent claims were initially invalidated in March 2010 by a federal district court in New York, after a complaint had been filed by a group of parties including the American Civil Liberties Union and the Association for Molecular Pathology. After appeal, the CAFC overturned this decision in a first judgment in July 2011. The plaintiffs then sought leave to appeal to the US Supreme Court.

Here is where the story gets a little complicated. One of the claims at issue in the Myriad patents related to genetic diagnosis of breast cancer predisposition. As such, the claim is analogous to claims that were at issue in another Supreme Court case, a patent dispute between Mayo and Prometheus. Because of the analogy between the claims at issue, and because the Supreme Court came to its decision the “Prometheus case” while still considering the Myriad case, the Supreme Court wanted the CAFC to take a new look at the Myriad case in the light of their judgment in the Prometheus case. So, the Supreme Court granted the request to appeal, vacated the July 2011 judgment by the CAFC, and ordered the case back to the CAFC for a new determination.

After an oral hearing in July, the second decision from the CAFC issued on 16 August 2012. In the new decision, available here, the CAFC concludes that the Prometheus decision does not alter their previous outcome, and has now stated twice that isolated genes are, per se, considered eligible for patent protection if all other requirements are met.

Perhaps this is not so surprising – after all, the CAFC decisions follow the established legal practice and reasoning that has been valid for at least twenty years, and maintain the status quo in the biotech industry. The really interesting question in this case has still not received an answer: What will happen if and when the question is brought up for final judgment by the Supreme Court?

Niklas Mattsson, European Patent Attorney

Focus on China

The fact that China is growing in importance is well known. To Awapatent, this growth is visible in our day-to-day work, both from the questions we get about IP in China from our European clients, and from the growing demand for our services as a European firm for Chinese clients. Naturally, we make it a priority to increase our focus on China.

As part of our efforts to get to know this immense country better, we have just spent a week in Beijing, conducting meetings, giving lectures and learning more about this different and challenging place. One of the highlights of this trip was a lecture on ”IP in Europe”, given by Niklas Mattsson at one of the institutes of the Chinese Academy of Sciences.

Needless to say, we have also had a lot of exciting food, met with a lot of interesting people, and travelled in a few of the city’s 70 000 taxis!

Niklas Mattsson, European Patent Attorney
Ted Hagman, Attorney at Law

Supplementary protection for combination products heading for setback at the CJ of the EU

Supplementary protection for combination products heading for setback at the Court of Justice of the EU

On 13 July 2011, the opinion of the Advocate General (AG) was released in the consolidated cases C-322/10 and C-422/10, “Medeva” and “Georgetown” respectively, concerning supplementary protection certificates (SPCs) for combination vaccines. In her opinion, the AG recommends the adoption of the “disclosure test”, rather than the “infringement test”, to resolve the question whether a product is protected by a basic patent in the sense of Article 3a of the SPC regulation.

The cases concern the interpretation of the EU regulation on supplementary protection certificates (SPCs) for medicinal products, Regulation 469/2009. An SPC may be granted to a patent holder when a product covered by the patent (the “basic patent”) must be subjected to clinical trials in order to be sold. An SPC provides a maximum of five years’ extra protection as a compensation for the delay in getting to the market.

The question in these cases is whether a product is eligible for SPC protection when it comprises a combination of active ingredients and only a subset of these ingredients is the subject of the patent. In particular, the issue has come up in connection with the development of multi-component vaccines, where one vaccine composition may contain many different disease antigens.

In the EU member states, there are currently different approaches. In a few national authorities, notably Germany and Denmark, the tendency is that a product is considered eligible for SPC protection if a combination product would infringe the basic patent (the so called “infringement test”). In most other national patent offices, the requirement is instead the so-called “disclosure test”, which mandates that the product must not only be covered by the patent in the infringement sense, but must also be explicitly described. Exactly how specific this description must be varies between member states. In other words, there is clearly a situation where guidance from the CJEU is needed, and several related referrals for preliminary rulings on this issue are pending. See also Sidsel Hauge’s article in AWA ip Review #2 2010.

The AG opinion released yesterday is a recommendation for the court’s final ruling, and, while followed in the majority of cases, it is not binding on the final judgment. The opinion contains a very detailed analysis of the EU law on the subject, and is interesting reading. To summarize the AG’s position in relation to the ultimate question, however, does not take more than a few words: the AG is of the opinion that the infringement test is definitely not the correct test, but that national law still has to be applied in order to determine whether a combination product forms the subject-matter of the basic patent.

In her opinion, however, the AG also recommends that an SPC should be available for a subset of active ingredients in a combination product when the subset is disclosed in the basic patent, even if the marketing approval concerns a combination of additional active ingredients.

It remains to be seen if the Court comes to the same conclusion in its final opinion.

Niklas Mattsson, European Patent Attorney, Awapatent

Most comprehensive patent reform in almost 60 years approved by US senate

Most comprehensive patent reform in almost 60 years approved by US senate

Historic breakthrough as USA gets to grips with “first-to-invent”, the enormous backlog of patent applications and simplifying procedures for filing patents in the USA.

On Tuesday 8 March 2011, the US Senate voted to approve the nation’s most comprehensive patent reform since 1952, entitled the “America Invents Act of 2011”. Among many other changes, the reform adopts a “first-to-file” patent system that is more in line with patent practice throughout the rest of the world. The next step in the legislative process is a vote by the House of Representatives.

According to long-held principles of the existing patent law, patents in the US have been awarded according to the “first-to-invent” principle. One consequence of this regime has been that researchers and developers have been forced to keep careful logs of their inventions to be able to prove that they were the first to develop a particular product or technology. In Europe and in most of the rest of the world, there is instead the “first-to-file” principle, which simply means that a patent is awarded to the first of multiple independent inventors to apply for a patent.

Among many proposals in the new legislation package, the most significant change, at least as far as us Europeans are concerned, is the endorsement of the “first-to-file” system. Intended or not, this signals that the US patent laws are becoming more like the European model (or, more correctly, the model used by the rest of the world). Another important change is the introduction of more ways to question the validity of a pending or granted patent without having to engage in a full-blown court trial. Other measures are directed to dealing with the nation’s massive backlog of patent applications (more than 700 000 at the latest count).

In my opinion, the new law (if passed) will eliminate some of the difficulties that small European companies and individual inventors have when filing for patent protection in the US, because of the differences in our respective systems. The shift to a first-to-file system will also, in time, make it easier to ascertain who is the rightful owner of a third-party patent. This should make life somewhat easier for small research companies and individual inventors. For example, the change removes one of the main reasons for having to write up detailed lab journals, and it will also make it cheaper and simpler to question the validity of blocking patents.

There are also minor amendments that aim to make the process as a whole less bureaucratic, such as a relaxation of the requirements for inventor signatures on filing. In my mind, foreign and US firms alike will benefit from the increased harmonisation and simplified rules, and the changes will make a big difference for everyone who applies for, prosecutes, trades in or litigates patents in the US.

Various efforts have been made over a number of years to push through this major overhaul of US patent law. As recently as in 2009 the proposal reached the House of Representatives without being enacted into law on that occasion. Now that the Senate has said yes to the proposal, the next stage is for the House of Representatives to vote on the issue. Spokespersons for the Senate Judiciary Committee say that a proposed bill is just around the corner.

In a comment from the White House, President Barack Obama says that he is pleased that the proposal has been approved, describing it as “the most significant patent reform in over half a century”, according to Reuters.

Niklas Mattsson, European Patent Attorney, Partner

BRCA patents in Europe

An ongoing lawsuit in the US has attracted a lot of attention worldwide. The American Civil Liberties Union has, together with other parties, sued the US Patent and Trademark Office, Myriad Genetics and others. On Monday 29 March 2010, a judge in a federal District Court in New York ruled that the “Myriad patents” in the USA are invalid, and that patents on isolated genes are not lawful. The verdict is likely to be appealed to the Court of Appeals for the Federal Circuit.

The controversy centers on patents on breast cancer genes BRCA1 and BRCA2. In 2009, when a decision was reached about the BRCA1 patents in Europe, Niklas Mattsson had the following to say about the European situation. The article has been previously published in Swedish in the magazines Pharma Industry and Onkologi i Sverige.

Patents on genes, especially human genes, have been a focus of fierce debate over the past ten years or so. The debate has been profoundly influenced by the controversy surrounding the “Myriad patents”, a number of patents covering the BRCA1 and BRCA2 genes, and the use of the genes in the diagnosis of cancer. The patents were initially held by Myriad Genetics Inc and a number of research institutes and US government agencies. Through two decisions in November 2008 the European Patent Office (EPO) decided the proper scope of the patents for the BRCA1 gene in Europe. See also our previous blog post.

Different views on gene patents
According to established jurisprudence in Europe, patents on isolated genes and their use are permissible, as long as the general requirements on novelty and inventive step are fulfilled. Detractors of the patenting of gene inventions often refer to the Myriad case, claiming that it illustrates the undesirable consequences of the current situation. These detractors argue that the system should be changed so that gene inventions can no longer be patented, or at least so that the possibilities are strictly limited. Proponents, on the other hand, have argued that the current patent system works well. According to the proponents, the problems arising in the Myriad controversy have more to do with business ethics and licensing policies than with a perceived but non-existent problem in the patent system.

Myriad and the BRCA patents
Myriad was established in 1991 as a spin-off from the University of Utah. The founder, Mark Skolnick, was a researcher at the university, and member of an international consortium that sought to find genetic links to breast cancer. Through extensive research, scientists from Myriad, the University of Utah and other institutions succeeded in identifying and sequencing the two genes BRCA1 (in 1994) and BRCA2 (in 1995). In addition, they identified links between certain mutations in the genes and an increased risk of breast and ovarian cancer.

Based on this genetic information, Myriad was able to develop diagnostic tests and start commercializing them. Naturally, the company had an interest in protecting its investment with the aid of patents.

Consequently, Myriad and its partners filed a number of patent applications in the USA, following these up with applications in other countries. In Europe, they made use of the EPC, filing the applications with the EPO. The scope of protection in the patent applications was directed to the genes as such, as well as the use of different gene variants to determine the risk of breast and ovarian cancer. In 2001 after what, in the circumstances, may be regarded as a more or less normal prosecution time, the EPO granted the patents with some amendments.

Broad BRCA1 patents granted in Europe
Through three different BRCA1 patents, Myriad was awarded exclusive rights to the isolated BRCA1 gene (European patent, EP, 705 902 B1), to use of the gene in cancer diagnosis in general (EP 699 754 B1), and to some 30 different mutations in the gene that are associated with an increased risk of cancer (EP 705 903 B1). Regarding BRCA2, there is one patent (EP 785 216 B1) covering detection of one specific BRCA2 mutation in a particular population, and a pending application (EP 1 260 520 A1). The present article is concerned only with the BRCA1 patents.

Having obtained these patents, Myriad contacted healthcare providers throughout Europe and offered licenses for the patents. Many people felt, however, that the prices that Myriad asked for using the technology were excessive: fees of up to 3,000 USD per sample were reported. Also, the licensing terms did not allow licensees to perform tests themselves, but mandated sending samples to Myriad for analysis. Myriad, on the other hand, has pointed out that its analysis is very accurate, and that the company provides a level of confidence that cannot be equaled in a general hospital or clinical laboratory that does not specialize in the analysis.

 In addition to the controversies surrounding Myriad’s demands, some commentators held that the situation illustrated a more general problem; namely, the negative consequences of granting this type of patent in the first place. Interestingly, very few other gene patents have attracted the same amount of attention, despite the fact that thousands of such patents have been granted in Europe, both before and after Myriad’s patent applications (see for example Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006)).

Opposition against the patents
Embodied in the EPC is a possibility to question the decision of the EPO to grant a patent through the filing of a notice of opposition within nine months from grant. The opposition is examined in a form similar to a lawsuit, and the EPO determines whether the patent owner or the opponent is right. The possible outcomes are that the patent is revoked in its entirety, limited in some way, or upheld in unchanged form.

In the light of the conflicts surrounding Myriad’s licensing policy and the general debate on gene patents, it is hardly surprising that the EPO received an uncommonly large number of oppositions against the BRCA1 patents granted in 2001. Also unusual was the fact that most of the opponents were not direct competitors of the patent owner, but organizations and institutes that were eager to question the existing system.

Oppositions were filed by, among others, Greenpeace, the Minister for Public Health in the Netherlands, and the Social Democratic party in Switzerland. Oppositions were also filed by the French research institutes (including Institut Curie) that had once been involved in the breast cancer consortium together with Skolnick and the University of Utah.

 
EPO decisions limit the patents
The opposition procedure concerning the first patent – that covering the BRCA1 gene as such – was concluded in 2007, following an appeal procedure (Board of Appeal decision T1213/05). After the dust had settled, it became clear that Myriad had lost patent protection for the gene as such in Europe. It is important to note, however, that the outcome was not the result of a decision that genes cannot be patented, but a consequence of Myriad’s failure to satisfy the traditional criteria for obtaining a patent. The patent applications originally filed described a DNA sequence that contained errors. After the filing of these applications, the correct DNA sequence was published before Myriad had filed a patent application disclosing this sequence. Thus, the correct DNA sequence was already known before a patent application containing this sequence was filed: it was, therefore, not novel. No novelty, no patent.

The final decision with regard to the oppositions against the two other patents on BRCA1-related inventions was reached in November 2008, also after appeals against the first instance decisions (Board of Appeal decisions T80/05 and T666/05). The written decisions were issued by the EPO on 7 March 2009. From the file histories it is clear that the broad protection sought by Myriad from the outset – and initially granted by the EPO to some extent – has been severely limited. What remains is patent coverage of one single specific cancer mutation, and of the detection of frame shift mutations in the gene.

The decisions state the exact reasons why the patent claims had to be limited, and in these two cases, too, this is due to failures to meet the “classic” existing rules, rather than any sign of a change in jurisprudence concerning gene inventions in general.

 It remains to be seen what future commercial effect these patents will have on the testing of BRCA1-related cancer risk. Whoever supplies tests for BRCA1 mutations for the purpose of diagnosis should study the patents as now finally decided, to ensure that there is freedom to operate.

A working system of checks and balances
The general debate on the patent system and gene inventions continues in Europe, despite the fact that the Myriad case is, to all intents and purposes, closed. At present, there is a discussion concerning whether the best way forward would be to introduce a limitation of the scope of protection, such that a patent owner should not be able to block all uses of a gene, even though it had never before been identified and isolated, but only obtain an exclusive right to the actual use described in the patent application. Some European countries have introduced such legislation, but it is too early to tell what the consequences will be.

To summarize, the European chapter in the Myriad Genetics patent saga is practically concluded. Despite widespread concern that European patent offices are over-generous in granting patents on gene inventions, it appears that the existing system and the conventional patentability criteria – including the possibility of opposition – have worked well in this case. The application of the criteria during EPO’s processing of the applications led to limitations on the patent protection that Myriad applied for, and what is left could be said to correspond to a reasonable compensation for the contribution to the art that Myriad and their collaborators provided.

 Niklas Mattsson, European Patent Attorney, Awapatent

Controversial gene patents finally decided by the EPO

During the last decade, the debate in Europe regarding the patentability of human gene inventions has been heavily influenced by “the Myriad case”, concerning patent applications by Myriad Genetics Inc (and others) that relate to the breast cancer susceptibility genes BRCA1 and BRCA2.

Through two decisions spaced less than a week apart, the European Patent Office has now finally settled the outcome of two European patent cases dealing with the BRCA1 gene.

On 13 November, an EPO Technical Board of Appeal decided T 666/05, concerning European patent EP 705 903, maintaining it in amended form. According to the EPO press release, the final scope of the claims is somewhat broader than what had previously been allowed by the first instance (Opposition Division), and relates to specific cancer mutations in the BRCA1 gene. The written decision in this case will not be available for some time, but we expect to have access to the granted claims as well as the minutes from the oral hearing within the coming weeks.

On 19 November, the same Board of Appeal decided T 80/05, concerning European patent EP 699 754. This patent had been completely revoked by the Opposition Division, but was re-instated by the Board of Appeal with amended claims that cover the detection of frameshift mutations in the BRCA1 gene. Again, the written decision will not be available for some time, but we will be able to comment in more detail shortly, once the minutes and claims are made public.

Opponents against granting patents on gene inventions have pointed to the Myriad case as illustrating the undesirable consequences of the existing European system, in which patents on genes are possible. Others have maintained that the patent system is working well, and that any problems arising from the Myriad case have more to do with unsound and aggressive licensing policies.

Whatever your standpoint on the issue of gene patents, it remains a fact that, among the thousands of patents on human and animal genes, the Myriad patents have attracted by far the most attention. For an interesting review of media and policy reactions to the Myriad case, see Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006).

Niklas Mattsson, European Patent Attorney

USPTO will not give up

Last fall, the US Patent and Trademark Office, USPTO, announced that they would make drastic changes in the rules concerning patent applications. Briefly, the USPTO rules mean that the applicant’s rights to file different forms of continuation applications are severely limited.

The rules were meant to become effective on 1 November 2007. Tons of companies and organizations protested against the new rules, and one inventor, Dr Triantafyllos Tafas, even went so far as to sue USPTO in a federal district court. Eventually, he was backed by the pharmaceutical giant GlaxoSmithKline.

On 31 October 2007, on the eve of the new rules taking effect, the federal judge issued a preliminary injunction against USPTO, inhibiting the new rules. This verdict was followed by a permanent injunction in the final decision issued 1 April 2008. In brief, the judge has determined that the USPTO has tried to exceed their authority, since the rules affect the basic rights of patent applicants. All patent applicants (and their representatives!) heaved a sigh of relief.

One could of course have hoped that this was the end of the story. However, on 7 May 2008, USPTO filed a Notice of Appeal against the verdict with the appellate court, CAFC, in Washington, DC. The schedule for the appeal case has just become official, and it looks as though a final verdict may be expected around the end of 2008. We’ll keep you posted…

Niklas Mattsson, European Patent Attorney

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