Posts by: Inga-Lill Andersson | (7) posts

The life sciences patent maze – USA

ON MARCH 4, 2014, the US Patent Office issued new guidelines on how to evaluate the patentability of inventions reciting or involving “laws of nature/natural principles, natural phenomena, and/or natural products”. Considering the fact that the first federal patent statute of the United States was established in 1790, one might be inclined to believe that the boundaries for what can be patented has long since been settled, but this is far from true. The explosive growth within the life sciences field in the last few decades has really put pressure on the patent system to adapt to the technologies “of our time”. Of course, the legislators in the late 18th century had no idea of concepts like gene therapy and cloning.

Under the current US patent law, the four statutory categories qualifying for patent protection are: process, machine, manufacture or composition of matter. Over the years the courts have interpreted the categories as excluding laws of nature/natural principles, natural phenomena and/or natural products.

Generally speaking, inventions in the following fields are at risk of being classified as ineligible for patent protection:

  • chemicals derived from natural sources (e.g. antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.);
  • foods (e.g. fruits, grains, meats and vegetables);
  • metals and metallic compounds that exist in nature; minerals; natural materials (e.g. rocks, sands, soils);
  • nucleic acids;
  • organisms (e.g. bacteria, plants and multicellular animals);
  • proteins and peptides; and
  • other substances found in or derived from nature.

The key factor in determining whether or not an invention qualifies for patent protection lies in the level of difference from what exists in nature; a claim reflecting a significant difference from what exists in nature is eligible, while a claim effectively drawn to something that is naturally occurring is not.

The new guidelines are intended to assist in making this determination, by establishing six factors weighing towards eligibility and six factors weighing against eligibility. On balance, if the totality of the relevant factors weighs towards eligibility, the claim qualifies for patent protection, while if the totality of the relevant factors weighs against eligibility, the claim should be rejected. Crystal clear, right? Well, the new guidelines also provide some specific examples to illustrate how the guidelines are to be implemented in practice. More information can be found here.

Initially, the new US guidelines appeared to be well-received within the patent community. However, as the practical consequences of the new guidelines sank in, an uproar of
protests have arisen. It also remains to be seen whether the courts’ view of the law is consistent with the USPTO’s guidance. Somehow, it seems unlikely that these guidelines will be the end of the story, so the evolvement of US patent law can be expected to continue for some centuries yet.

Inga-Lill Andersson, European Patent Attorney, Partner

Report from BIO 2013 in Chicago

On April 22-25, 2013, the yearly BIO International Convention was held in Chicago. This is the largest global event for the biotechnology industry, and it attracts research companies and service providers from all over the world. The BIO event provides an excellent arena for establishing new partnerships and collaborations, and the exhibition hall literally vibrates of knowledge, curiosity, internationalism, open-mindedness, and a tangible belief in the future.

Intellectual Property has become an increasingly important part of the biotech industry, and this is also reflected in the number of IP firms being represented at the BIO Convention. Several IP firms could be found among the exhibiting companies, and in addition to that, a huge number of IP professionals were included in the attendee list. So for us, the BIO means a great opportunity to expand our international network, and also to maintain established collaborations.

The BIO also offers a lot of social receptions, serving not only the chance to meet with a lot of strikingly nice people, but also to have a taste of exotic food, drinks, and cultures. One of this year’s favourites was undeniably the hula hula dancing to be experienced in the Hawaiian Pavilion.

Next year, the BIO is heading towards one of the world’s most influential biotech communities; San Diego, and we are already looking forward to meet with new and old friends in sunny California.

Inga-Lill Andersson, European Patent Attorney, Partner
Mikael Henriksson, European Patent Attorney

New dosage regimen may be patented, but no more Swiss-type claims

The Enlarged Board of Appeal of the EPO clarifies, in decision G 2/08 of 19 February 2010, that it is possible to obtain a patent for a medicament known to treat a specific illness for use in a different method for treatment of the same illness. However, such inventions may not be claimed in the format of so-called Swiss-type claims.

The European Patent Convention, EPC, specifies that European patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (hereafter referred to as methods for treatment). However, the patentability of any known substance or composition shall not be excluded for use in such a method. These provisions in combination with case law, in particular the earlier decision from the Enlarged Board of Appeal G 5/83, have led to the rather complicated way of protecting the second medical indication called the Swiss-type claim: Use of a substance or composition X for the manufacture of a medicament for treatment of disease or condition Y.

Since December 2007, the EPC specifies that any known substance or composition can be patentable for any specific use in methods for treatment. The intent is to eliminate any legal uncertainty regarding the patentability of further medical uses and to permit purpose-related product protection for each further medical use of a substance or composition already known as a medicine. Thus, it is now possible to formulate claims on a second medical indication as: Substance or composition X for use in the treatment of disease or condition Y. However, the EPC does not define the nature of such further therapeutic use of a known substance or composition other than by saying that it must be “specific”. It does not give any definition of the degree of distinctiveness required from the new use in order for it to be “specific”, and in particular whether a new method for treatment of the same disease or condition could constitute such a ”specific” use.

Decision G 2/08 relates to a European patent application with Swiss-type claims directed to a known substance for use in treatment of the same condition as disclosed in prior art. The patent application was refused on the grounds of lack of novelty and because it related to a method for treatment. The only novel claim feature resided in a specific dosage regimen. The remaining issue was whether a dosage regimen feature can be recognized as a further medical indication within the meaning of the EPC.

The Enlarged Board of Appeal confirms the previous liberal decision T 1020/03 and comes to the conclusion that the new use does not need to be the treatment of another disease. The “specific” use may thus reside in something else than treatment of a different illness, and there is therefore no reason to treat a feature consisting of a new dosage regime of a known medicament in any other way than one would treat any other specific use acknowledged in prior case law. It is stressed that the claimed definition of the dosage regime must not only be verbally different from what is described in the art but must also reflect a different technical teaching.

During the revision of the EPC, it was considered that this purpose-related product protection should give an equivalent protection to that of Swiss-type claims. It is therefore very interesting to note that the Enlarged Board of Appeal in the present decision concludes that “It appears that the rights conferred on the patentee by [purpose-related product claims] … are likely broader [than Swiss type claims] …”.

What might be most noteworthy and surprising in this decision is that the Enlarged Board of Appeal states that for a claim with subject-matter rendered novel only by a new specific use of a medicament, such claim may no longer have the format of a so called Swiss-type claim. The Enlarged Board of Appeal notes that patents have been granted and many applications are still pending seeking patent protection for Swiss type claims. Therefore, in order to ensure legal certainty, the abolition of this possibility shall have no retroactive effect. It appears that the prohibition on Swiss-type claims will only apply to applications having a date of filing or priority more than three months after publication of the present decision in the Official Journal of the EPO. As soon as this time limit is fixed, this information will be provided on our website.

Inga-Lill Andersson, European Patent Attorney
Mikael Henriksson, European Patent Attorney
Maria Stenbäck, European Patent Attorney

Centocor (Johnson & Johnson) awarded the largest patent verdict in U.S. history

1.67 billion U.S. dollars, $1.16 billion in lost profit, and $504 million in royalties. That’s what Centocor is awarded in damages for infringement of their patents.

On Monday, June 29, a jury found that Abbott Laboratories had willfully infringed two patents covering antibodies against tumor necrosis factor owned by Centocor. Abbott’s drug Humira was found to infringe Centocor’s U.S. Patent Nos. 7,070,775 and 7,276,239. Humira is widely used in the treatment of various forms of arthritis, and is also approved for psoriasis and Crohn’s Disease.

Humira has been somewhat of a blockbuster for Abbott, and is said to have generated $4.5 billion in global sales last year. Centocor has made it clear that it isn’t seeking to block sales of the drug, only to get a share of the profit.

Therefore, this verdict is in a way the ultimate evidence that the patent system actually works in practice: it gives a patent owner a time-limited exclusive right to prevent others from commercially exploiting the protected invention. And needless to say, a strong patent portfolio can have a significant value. Ask Centocor.

Inga-Lill Andersson, European Patent Attorney

What are the consequences of the decision from the Federal Circuit on the new USPTO regulations?

In August 2007 the United States Patent and Trademark Office (USPTO) issued a rules package intended to limit the number of patent claims in a single patent application to 25 (including a maximum of 5 independent claims) and also to restrict the possibility of filing what are known as “continuation applications”.

The main aim of the proposed rule change was to reduce the amount of work involved for the Patent Office, e.g. in examining applications with multiple patent claims and, as a consequence of this, to give the USPTO an opportunity to catch up on the backlog of unexamined applications.

However, just one day before the new regulations were due to enter into force, the process was halted by a federal court following a complaint filed against the USPTO by the pharmaceutical giant GlaxoSmithKline. The USPTO then appealed against the decision in a higher instance, the Federal Circuit.

The situation today
The Federal Circuit’s decision of 20 March 2009 amounts to only a partial restriction of the USPTO’s prerogative to introduce the new rules. Specifically, the court finds that the USPTO has no legal authority to limit the number of continuation applications, which is very good news for the life science sector in particular. As many as 70–80% of the patents granted to certain biotechnology companies are based on this kind of application.

Nevertheless, the court concedes that the USPTO does have the right to limit the number of requests for continued examination (RCEs) and to impose a maximum limit of 25 patent claims.

The matter will now be referred back to the district court for further investigation. For example, a decision must be reached on whether the proposed new regulations exceed the powers of the patent office in any other way.

How the USPTO will subsequently set to work to introduce the new regulations remains to be seen. It is worth recalling just how much has changed since the proposal was initially submitted; the economic landscape is totally different, there is a new president in the White House, and there are signs that the number of applications filed with the USPTO is falling. This in itself may be sufficient to sweep away the problems that the new regulations were intended to solve.

The news that the USPTO does not have the authority to limit the number of continuation applications is welcome. A possible limitation of the number of RCEs is less significant, since a continuation can always be filed instead of an RCE. And, anyway, RCEs may be filed if the applicant can cite special reasons for doing so.

On the other hand, if the number of patent claims is limited to a maximum of 25, this will likely have a greater effect – especially among life science and pharmaceutical companies, which often have many claim categories and, by extension, many patent claims. It will, of course, still be possible to file more than 25 patent claims, but only on condition that an examination support document (ESD) is included with the application. The demands made on the ESD are, however, extremely high: in effect, they require applicants themselves to do the work of the patent examiner. Presumably it will therefore be both cheaper and simpler for applicants to file one or more continuation applications rather than an ESD.

Similar and dissimilar developments in Europe
It is interesting to note that, in many ways, developments in European patent legislation are mirroring what is happening in the USA. However, instead of setting specific limits, the Europeans have opted to use fees as a means of controlling the number of patent claims. Extremely high fees were introduced around 12 months ago for applications containing more than 15 patent claims. With effect from 1 April 2009 fees for applications with more than 50 patent claims have been increased even further, and a new excess-page fee has been introduced for page 36 onwards in applications of more than 35 pages.

Like in the US, there has been much discussion about introducing limits on filing divisional patent applications in Europe due to an asserted misuse of the system, a phenomenon referred to as “abusive” divisional applications. As a result, the European Patent Office (EPO) has very recently, on March 26, 2009, decided on restricting an applicant’s possibilities to file divisional application. You can read more about the EPO’s decision on my colleague Eva Carlsson’s blog post.

This is in contrast to the latest developments in the US, where it has been established that the possibilities to file continuation applications (corresponding to divisional applications) may not be limited.

Inga-Lill Andersson, European Patent Attorney

No conflict between scientific research and commercialisation

It’s a widely held myth in the world of medical research that patent is a dirty word, merely a way of making money out of your research. In actual fact, applying for a patent has much in common with publishing a paper in a scientific journal. The difference is in the purpose of the exercise.

Academic researchers regularly suggest that it is unethical to protect their innovations with patents. They are disdainful of the kind of commercial research undertaken by the pharmaceutical companies. All they want to do is to be able to publish their findings in scientific journals. They say they want to share the results of their research freely and, as almost all research today builds on earlier discoveries by other scientists, they want to contribute to the advance of science in a spirit of altruism.

Patents, however, do not restrict a researcher’s opportunities to share information. On the contrary! Once a researcher has applied for a patent, he or she can publish their research results the very same day. The patent application itself is also published and here the innovation must be described in such detail that it is possible to reproduce it. There’s nothing hush-hush about that! In fact, lack of reproducibility is one reason to reject a patent application, or even to invalidate a patent after it has been granted.

Nor can you overlook the obvious. Given the sky-high cost of developing today’s pharmaceuticals, many would never have seen the light of day if it hadn’t been possible to protect them with patents. What a disaster that would be! Pure research without a commercial incentive is indispensable if we are to understand how the world works. But there is no reason to condemn the work of developing patented drugs simply because these same drugs may one day make a profit for the companies that developed them. After all, advances in science depend both on “free” research and on patented innovations.

Inga Lill Andersson, European Patent Attorney

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BIO International Convention – a dazzling experience

“Innovate, heal, fuel, feed the world” – that is the theme of BIO 2008, the world’s largest convention for biotech, and a global life science event taking place right now in San Diego, California. The convention takes place for the 16th time and it is larger than ever before, with more than 20,000 participants from all over the world.

Arriving at the Convention Center, we immediately got the overwhelming feeling that the people gathered here will have an impact on the future of each and all of us.

The enormous exhibition hall was vibrating with IQ, seminars, bar hopping, partnering meetings, discussions and not to forget – tango. The Scandinavian Pavillion held a seminar disclosing the secret of Sweden‘s drug development pipeline. Among the speakers was Ewa Björling, Minister for Trade.

The first day of BIO 2000 ended with a spectacular reception on the USS Midway in the beautiful San Diego Harbor.

We are now trying to digest the impressions from the first day. It is a dazzling experience to meet representatives from literally every corner of the world and to be a part of the international biotech community!

Inga-Lill Andersson, Karl Olsson, European Patent Attorneys / Attorney at law and Maria Stenbäck, European Patent Attorney

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