Patent lapse

As a simple example, the life span of a US patent used to be easy to calculate US patents used to last 17 years, calculated from the date of issue. But US patents filed after 7 June 1995 now last 20 years, calculated from the date of filing (which has been typical outside the United States for many years). Also, a form of tax, known as a maintenance fee, is now imposed on US patents. If the patentee does not pay each fee as it becomes due, the patent lapses. Lastly, patents can be extended via two different mechanisms. Under the rules of Patent Term Restoration, certain patents, mostly pharmaceutical patents, can be extended for up to five years. The theory is that the patentee has suffered an injustice because he or she was essentially denied a portion of the patent s life and not allowed to earn potential profit from the patented invention because of the need to first obtain regulatory (e.g. FDA) approval before bringing the product to market. Under the rules of Patent Term Adjustment, extensions can also be obtained for certain procedural delays during the prosecution of a patent application. The actual term extension for each patent is determined by its specific facts. These two calculations are independent of one another. 

With the original situation that the barrier screw was patented in Europe by Maillefer, a Swiss cable machinery manufacturer, there was little interest in Europe in this technology other than by insulated wire and cable producers. When the patents lapsed, interest focused on designs emanating from developments which had taken place in the USA. 

French scientists at the Pasteur Institute, however, promptly dispelled some of Prontosil s mystery, splitting the molecule into a red dye component and an old chemical, sulfanilamide, its 1909 patent long since lapsed (2 ). The suspicion arose that Domagk, an I. G. Farbenindustrie researcher, had rediscovered sulfanilamide, and that the manufacturer had held it off the market until it could be presented in a new, complex, disguised, and patentable form (2, 3 ) Whether or not the suspicion was true, the French scientists, by showing that sulfanilamide was the therapeutically active fraction of Prontosil, shattered the gigantic Germany company s profitable plans. 

These data tell us that to be a successful player in the pesticide industry you must be a large organisation with the ability to invest a great deal of support into the discovery (in most cases), development, manufacture and marketing of your products. There are some organisations that have built their successful position on their ability to manufacture and formulate commodity products, those products that were discovered some years ago and whose patents have lapsed, thereby allowing organisations, other than the inventor to make, formulate and sell the product internationally. 

Finally, after the patent has issued, it must be maintained . Maintenance fees must be paid periodically to each country in order to keep the patent in force. Failure to pay results in a lapsed patent. 

As the field of homogeneous catalysis matures, the patent protection on catalytic routes will lapse. It is always permissible to synthesis and test small amounts of catalyst in the laboratory. However, before scaling up a process it is advisable to check whether the process is protected by patent. If it is, a licence will be required to operate the process. 

Norling, P.M. (1977) Time-lapse free-radical polymerizable composition. US Patent 4,000,150. 

The supply chain features, as we noted in Chapters 1 and 2, are part of what we have called the "extended" product. Competitor imitation or lapses of patents eventually enable competitors to imitate the physical features of the product itself. Extended product and supply chain features, in turn, often become the principal basis for competing. 

Almost every week several callers the world over inquire as to sources of phosphate fibers. They ask, Are you manufacturing this product Is anyone, anywhere, manufacturing this product Regretfully, I must tell them that I know of no commercial source of the fibers. Response to this product has been very rewarding to me, as an inventor. Monsanto s management made a decision not to manufacture the product and to allow their patent estate to lapse, rather than pay annual fees required to keep the estate active. The problems with potential lawsuits are ever present. 

In this situation, the enzyme is likely one that was obtained through cloning and expression of a gene obtained through research or the public domain (literature, public databases, expired or lapsed patents, etc.). The major issue here is that a production process must be developed for the enzyme and this can add to the time required to establish a supply. The plus side to this situation is that, because of the FTO situation, multiple vendors can be developed by the customer, if necessary. It may also be useful to have a strategy for maintaining the FTO for the enzyme in question as it is possible that others may independently discover the same enzyme or a close variant and potentially block the FTO by obtaining a patent. 

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