From IP to NP, Day One: Part 3
After lunch and another opportunity for congenial notworking networking, the first session of 'From IP to NP' at the Dan Panorama Convention Center, Tel Aviv, offered a choice of
First to speak was Noam Mushkin (Perrigo) on "Managing a global corporate patent portfolio". Noam gave a brisk and effective overview of how a generic pharma company gets a product to market, looking not just at IP factors but at outside issues that have an impact on IP -- particularly regulatory issues. If you couldn't tell your ANDA from your DMF, or didn't know that your QBD emerged from your PDR, you'd have been pretty well KO'd.
Noam painted a picture of a constantly changing task of reaching a moving target, in which there is a constant input of commercial, technical and legal information, including the impact of third party patents that address means of new product testing and putting products into use. Product development has to be carefully managed, for example to take testing and safety data from one territory where there is a brand and deploying it another where there is no brand. Ultimately what one needs is a well-integrated multidisciplinary task-force.
Micaela Modiano (Senior Partner, Modiano & Partners, Italy) came next, on "Cost-effective IP protection in Europe: PPH and other tricks". Recollecting that one of the best ways to make patents cost-effective was to keep costs down and promising to teach us just three things, Micaela started by looking at patent strategy and asking "What is Europe?" -- a question easier to pose than to answer (especially when it comes to places like Switzerland and Turkey). Whatever the answer, Europe is a large market with over 540,000,000 inhabitants, so applying for a European patent via the European Patent Office should be considered at the beginning, when filing and translation costs have to be thought about. Translation costs -- where there are a possible 38 languages -- can be crippling, though there is a trick: translations won't be needed initially. You can file initially for a large number of countries, then prune them till all you have left are the countries that are your serious markets. Micaela's list of no-translation, claim-translation and full translation countries is quite handy, take note if you are going to download the speakers' PowerPoints.
Micaela told us a tale of the bewilderment of some European patent examiners who were astonished that some patent applicants weren't prepared to press to grant and get their applications translated after receiving their notice of allowance: they had to persuaded that sometimes a patent that looks quite exciting, an indeed commercially viable, when it's applied for but was no longer of much use by the time the grant approached.
Finally Micaela addressed the patent prosecution highway (PPH), which is sometimes highly useful, sometimes not -- since it all depends which patent office is recycling the work of which other office. When it's opted for, the European Patent Office is invited (but not compelled) to take account of a USPTO examination, she noted; nor is it compelled to accelerate the filing. Micaela's comments on the official statistics (on her PowerPoints) make amusing reading, though not for US examiners. Apparently the PPH is much loved by the EPO's managers, but much hated by examiners who are none too keen on some of the work of their US brethren. Some cases are however ideal for the PPH: those are ones in which the EPO has a hang-up about the patent's subject matter: business methods, software inventions and surgical and diagnostic methods. Politically, the PPH is popular and more territories have been added to it. With better quality performance all round, the PPH will be improving. Think before you opt for it, but don't just use it systematically.
Yoav Sin-Malia (Senior Patent Examiner in the pharmaceutical sector of the Israel Patent Office) then presented a paper, "Different search approaches by applicants and the Israeli Patent Office", covering accelerated examination and reduced application fees for small applicants. He warned that broad claims in a patent might make an adequate search impossible to perform. Next, Yoav reviewed some of the major advanced search databases -- STN, Thomson Innovation and EPOQUE Net and Questel -- and their areas of particular value. There are different types of search, he pointed out, and that of the patent examiner, for example, is limited to the area of the claims while that of the applicant is not. In conclusion, a good search opinion was of great value in taking the application on to its second stage.
Idit Ophir (Arad Ophir) then mentioned the types of patent search and their functions: novelty, patentability, freedom to operate, validity/infringement, legal status and family information, and so on. Most of these do not concern the patent examiner at all. Even for the applicant who doesn't have a lot of money, it's worth spending plenty to ensure a good search, since it can save a fortune.
Sharon Hausdorff (Deputy General Patent Counsel, Teva Pharmaceutical Industries Ltd) then addressed "Due diligence". When it comes to due diligence, "You're the legal counsel and your job is to suck the fun out of everything", but it's tough for lawyers: "the time available for due diligence is always inversely proportional to the value of the deal", but deal-breakers must be rooted out -- even if it's only something as trivial as the earliest date on which a competing product can lawfully enter the market. You can't do due diligence properly without knowledge of exactly what the facts of the deal and its subject matter are; if not, you can't identify those issues that are truly relevant from those that are not.
Due diligence can't be stretched from one territory to another: "what's good to go in the US may not be good to go in the UK". Likewise, apparently 'safe' IP might come with strings attached, especially where the invention is supported by public funding or constitutes a service invention in which rights are disputed or compensation payable. Doing due diligence requires some degree of understanding of the technology covered by the target IP: a vendor's description of the gap between its patents and the prior art can't be taken at face value, however earnestly it's expressed.
The regulatory environment must also be appreciated, especially since different regulatory authorities have a different tolerance of what is allowed or not. "Diligence is the mother of good luck", said Benjamin Franklin -- and that applies equally to due diligence. Do it carefully, but trust your instincts and be prepared to take that risk.
1. (for senior management & stakeholders) "IP Trends in Asia"This Kat opted for the one in the middle: Entrepreneurs and IP Managers: Seminar on IP Rights Registration in a Constantly Changing World, Part B: Corporate Patents Management, Idit Ophir (Arad Ophir) and moderated by Sandy Colb (Sanford T. Colb & Co.)
2. (for entrepreneurs and IP managers) Seminar on IP Rights Registration in a Constantly Changing World, Part B: Corporate Patents Management
3. (for entrepreneurs and IP professionals) Trends and Rulings Regarding Service Inventions
 |
| Europe: more languages than colours |
Micaela told us a tale of the bewilderment of some European patent examiners who were astonished that some patent applicants weren't prepared to press to grant and get their applications translated after receiving their notice of allowance: they had to persuaded that sometimes a patent that looks quite exciting, an indeed commercially viable, when it's applied for but was no longer of much use by the time the grant approached.
 |
| An EPO examiner reacts to a PPH search report |
Due diligence can't be stretched from one territory to another: "what's good to go in the US may not be good to go in the UK". Likewise, apparently 'safe' IP might come with strings attached, especially where the invention is supported by public funding or constitutes a service invention in which rights are disputed or compensation payable. Doing due diligence requires some degree of understanding of the technology covered by the target IP: a vendor's description of the gap between its patents and the prior art can't be taken at face value, however earnestly it's expressed.
The regulatory environment must also be appreciated, especially since different regulatory authorities have a different tolerance of what is allowed or not. "Diligence is the mother of good luck", said Benjamin Franklin -- and that applies equally to due diligence. Do it carefully, but trust your instincts and be prepared to take that risk.
