Secondary Use Claims – Some Thoughts…

second use

Yesterday I attended a meeting of the Association of Israel Patent Attorneys in ZOA  House, Tel Aviv. The invitation and program were blogged here.

The topic under discussion was Secondary Use Claims. Unfortunately, I arrived late and missed the first talk by Adv. Yair Ziv, but caught most of Adv. David Gilat’s presentation, that of Dr Ron Tomer, and that of Ena Pugatsch.

The event was well-organized and well attended. From the remains of the refreshments by the time I arrived, they seemed the usual ZOA fayre. Kudos to the committee headed by Ex-Commissioner Dr Noam, for organizing the event. There were 85 participants in the meeting. This is impressive for a highly specialized topic at an event open to a small organization (noting with approval however, that there were both lawyers and in-house patent coordinators present that are not patent attorneys and thus not members, and also trainees).

Adv. David Gilat posited that drug patents were necessary to compensate the drug developers for their investment, and that secondary uses were also the result of research.  Dr Ron Tomer (confusingly called Dr Yaron Tomer in the original invitation to the event) expertly and clearly countered all of Davidi’s positions, and demonstrated that the pharma industry were creatively filing secondary uses that lacked inventive step and were obvious. He gave various examples. Firstly, he referred to sildenafil citrate, originally developed for treating angina and now used almost exclusively as a treatment for erectile disfunction, as a hard problem. (I thought it was a flaccid problem and a hard solution, but I digress). He went on to argue that an oncological drug for one type of cancer may fairly obviously be tried for another type of cancer since the underlying effects of the drug would treat both mutant cells the same way.  He noted that patents were not awarded for research but for inventions. He claimed that there was nothing new in the drug, despite the new use. He gave convincing examples of ever-greening, and also argued that if it is surprisingly found that a drug treatment for gastro-reflux also kills bacteria in the stomach, then the patient using it takes the same drug for the same purpose that he took it for originally. Since the drug is public domain he could take the generic drug, but to kill the bacteria, he’d have to take the patented drug for a couple of weeks and then move back to the generic. similarly, someone taking a generic statin for cholesterol, on being diagnosed as having genetic cholesterol, would have to switch to the patented version offering protection for this ‘secondary use.’ The talk was intelligent and entertaining, and it was a valuable demonstration of the ubsurd results of secondary use patents.

Ena Pugatsch gave an example of a secondary use claim for a mechanical device that issued in Israel and was upheld by the courts. The device in question was a blackboard that could be used as a screen for showing projected images, where the device and method of manufacture were known but the secondary use wasn’t, and the court upheld the patent. Comparing to European case-law and to US law, she felt that the ruling was ‘problematic’ (a nice way of saying that she considered that the court had got it wrong).

When the floor was opened for questions Mr Zebulun Tomer (Ron’s father and the director of Unipharm) took the opportunity, as he has done on other occasions, to give a little impassioned speech, rather than a question. He made some noises about the results of lobbying and argued that Section 7 prohibits therapeutic treatment of the person and that no-one can convince him that a secondary use is anything other than a method of treatment of the person. Instead of merely pointing out that the issue wasn’t convincing him, but of convincing neutral judge, Adv. David Gilat agreed with him, but said that this was precisely what the Use Claim (Swiss type claims) were for – that is, to allow patents for pharmaceutical methods of treatment despite the prohibition for patents for methods of therapeutic treatment, and this was because of the costs incurred in research and development.

COMMENTS

David Gilat spoke well as would be expected from an experienced litigator. Dr Tomer’s response was also very clear and well constructed. Ena Pugatsch is not an orator, nor is Hebrew her first language (or, I expect, her second language). Nevertheless, her talk, though not the most fluent, was the most thought provoking. All three speakers had far too much content per slide, but none are lecturers. Designing good slides is an art.

David and Ron each presented their opposing positions. As Gilat Bareket represents drug development companies and the Tomer family own Unipharm which manufactures generic drugs, their views were hardly unexpected. I suspect that those in the audience actively involved in prosecuting or litigating pharmaceuticals have equally strong positions based on their source of income. (Richard Luthi, another leading litigator who represents pharma, once told me that under the former Commissioner Dr Noam, the pharmaceutical development industry didn’t have a chance. Whether Dr Naom was biased, whether Unipharm had better arguments, or whether Adi Levit is simply a better litigator, is open to discussion).

The percentage of my income coming from work on pharmaceutical patents is very small. I’ve been involved with both local and foreign clients on both sides of the fence. I tend to find the generic companies’ arguments more persuasive, but can’t tell if this is an inherent bias or whether their arguments are actually better. It is also possible that drugs that are opposed or challenged in cancellation procedures are ones that generally should not have issued, and the both the drug development industries and their litigators have an uphill battle. What is clear, is that Unipharm have had some impressive victories in recent years against Mercke, Smithkline Glaxco, Lunbeck, etc.

Ena’s talk got me thinking. I believe that the original Section 7 law against methods of therapeutic treatment is a historic artefact designed to protect doctors from being sued and represents a moral position that despite obvious utility, novelty and inventive-step, such subject matter would not be patentable. It is a remnant from a period predating the modern pharmaceutical industry. David is correct however. Without effective patent protection, drug development companies would not invest the significant sums required to research and bring a new drug to market. The long approval period also justifies patent term extensions. This development is indeed the result of lobbying, but is, nevertheless, justified. What may not have been justified, is to apply the extensions on cases that were already filed, granting the pharma industry a massive handout that perhaps resulted in them NOT investing in developing new drugs.

Drug developing companies can fairly be accused of ever-greening, and their tactics in filing for secondary uses are commercially driven. However, despite the Special 301 Reports, the generic drug industry are not Robin Hood like outlaws. It is there right to challenge the validity of patents, and some applications are allowed that shouldn’t be. Nevertheless, I suspect that sometimes oppositions are filed for commercial rather than solid legal reasons.

The Swiss Claim (use claim) format is a legal work-around the method of therapeutic treatment clause. Use claims are acceptable in European and Israeli law and are essentially method claims. They do not exist in the US, however in the US one can file methods for therapeutic treatment. What one cannot do, is enforce them against the doctor or surgeon.

After TRIPS, it is clear that one cannot exclude drugs from patent protection. One can still have a principle against patenting methods of treatment. However, countries have to allow patent protection for drugs.

As David Gilat reminded us, patent term extensions were indeed allowed as a package with and justified by a bone thrown to the generic industry – the so-called TEVA amendment, allowing the generic companies to experiment and obtain marketing approval, but not to stock-pile generic patents prior to the patent terminating.  However, one right does not balance the other. Mr Zebulun Tomer is correct that the current balance is the result of lobbying. There were lobbyists on both sides. The ‘one size fits all’ patent law does fail for pharmaceutical patents if such patents have, in the past, been allowed after the 20 year expiry date.

As to second use, the first thing to understand is that use claims are method claims and should be treated as such. The Rav Bareakh crook-lock ruling by the Israel Supreme Court allows contributory infringement and inducement to infringe. However, in Srori vs. Regba, the fact that a sink could be mounted flush with the work surface was insufficient grounds to grant an injunction against the importer, since, As Adi Levit argued effectively, the sinks in question could be mounted under the work-surface, or could be mounted with the lip overlapping the work surface (over-mounted) or could be filled with earth and used as a flower-pot.  Thus, the proper infringers were the kitchen installation companies, and there was no effective bottle neck to sue in the supply chain.  Getting back to secondary uses for drugs, lets assume that using aspirin to dilute blood to prevent thrombosis is indeed novel and inventive. This does not prevent patients buying aspirin over the counter for treating aches and pains and then using it for the new patented use. Manufacturers of aspirin are not infringing the secondary use patent. Similarly, generally speaking, patents for secondary uses are not for the drug itself, but for its use in treating a particular illness. They are method claims. I agree with Dr Ron Tomer that the manufacturer is generally not the infringing party. The physician or patient might be, that the US exception against suing health care officials should apply. There are, of course, some particular dosages that are borderline cases. In such cases, the newly packaged drug is a new product. Whether or not, it is also inventive, is arguable.

Referring back to the blackboard; Ena is correct, it was not a new product, nor was its method of manufacture new. The novelty lay in the method of use, i.e. for projecting an image thereonto. The patent provided grounds for suing schools and teachers for direct infringing – both customers of the patentee and of competitors. This is a patent without teeth. If competing manufacturers note that their blackboards may also serve as a screen, is this inducement to infringe? Maybe it would be better for them to note that although the blackboards may be used as screens, this use is protected by Israel Patent Number IL XXXX, and as long as the patent is valid, is not allowed. This is very different from the crook-lock case where the imported part was designed and manufactured for combining with two common elements to provide the crook-lock, and could only be used for infringing the patent, or for a trivial use such as a paper-weight or land fill.

At the end of the day, it is the job of the patent attorney to draft patentable and enforceable claims. I note that in the US, the pendulum has recently swung away from secondary infringement. See US Supreme Court Ruling 12–786 Limelight Networks v Akamai Technologies Inc et al., June 2, 2014. I believe that often these cases result from poor claim drafting, as do Marksman disagreements. In the past, I drafted and successfully prosecuted a  patent for a kitchen sink AFTER Tsrori vs. Negba. See  US6782593B1.  I’ve also had fun drafting together with Adv. and Patent Attorney Tami Winitz a patent for a new method of using an existing heart valve, where I believe the creative claim-set provides enforceability. See US8408214B2.  Patent attorneys drafting applications try to protect their client’s inventions and stretch the law. Litigators opposing patents do the opposite. We all have our roles to play.

 

3 Responses to Secondary Use Claims – Some Thoughts…

  1. Sharon says:

    you didn’t miss much. the first presentation was a mere short introductory “flight of the bird”-style review of the relevant normative infrastructure (probably for the sake of the few non-prosecuting IP lawyers in the crowd) that any certified patent attorney is already well familiar with.
    I wish I didn’t have to miss most of Ena’s talk to take a call I was waiting for from an examiner at the PTO but that is just the way things are …

  2. Erez Gur says:

    The patent system does not exist for giving out certificates attesting to the absolute novelty and non-obviousness of an invention, rather to encourage innovators to invest money and time in their ideas to help society.

    Second medical use patents involve finding a new therapeutic use for a proven safe chemical entities, meaning potentially life saving at a remarkably low cost. Considering that it is next to impossible to find new chemical entities as medicines, society should do everything to help invention of second medical uses, including issuing patents that are “obvious” to someone who has never worked in a lab or never administered a new chemical compound into a living being, and wondering if the subject was going to die.

    I am personally familiar with a known and safe drug that is a candidate for treating breast cancer. It works in vitro, but no one will ever know if it works in vivo because it is impossible to get a patent for the drug.

    That is the argument that, in my opinion, trumps all of Dr Ron Tomer’s great humor and wit.

    • Sharon says:

      Erez you have a good point which often eludes those who are charged with duty or authority to decide obviousness issues – sometimes a contribution that appears ‘trivial’ to the lay man is in fact to the expert community not so trivial at all, as there are all sort of basic assumptions, constraints, practical considerations etc. known only to the professionals and of which the unskilled person knows nothing about! as always, some degree of humbleness is a good virtue in that respect.

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