Generic Challenge:. Martin a. Voet

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Generic Challenge: - Martin a. Voet

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a billion dollars in royalties. His inventions ranged from Hot Wheels track to bar coding (the black and white bars and numbers on just about every box of something sold today), and his patents covered something that just about every commercial enterprise did. He may have had more patents than Edison, but unlike Edison, he never actually made or perfected any of these inventions himself.

      This kind of patent jokingly became known as a “submarine” patent because it stayed hidden under the surface for a long time and then arose and blasted you out of the water when you least expected it. That was because at the time, patent applications were kept secret in the U.S. until they were granted and Lemelson never filed his patents outside the U.S. where they would be published. By making the date of a patent based on its earliest effective filing date instead of its grant date, and by publishing pending patent applications, it essentially ended new submarine patents starting June 8, 1995.

      And while the courts of justice grind slow, they grind fine. In Symbol Technology v. Lemelson (Fed. Cir. 2005), the Court of Appeals for the Federal Circuit, which handles all patent appeals from the Federal District Courts, ruled that Lemelson’s patents were unenforceable because of the way he got them, namely by intentional delay or as the courts have been calling it “late claiming”. This undoubtedly caused his successors to suffer some heartburn at their Aspen ski lodges, but presumably not Mr. Lemelson, as he is likely too busy filing further continuing applications in the heavenly Patent Office.

      So to recap, in the U.S., a patent having a filing date on or after June 8, 1995 has a term of 20 years from its earliest effective filing date. Patents filed before June 8, 1995 have a term which is the longer of 20 years from its earliest effective filing date or 17 years from its date of issue. In the rest of the world, patents typically last 20 years from their filing dates. In Japan, patents are also granted for 20 years from their filing dates, but not longer than 15 years from their grant date.

      There are also complicated Patent Office rules which provide for patent term adjustments which add additional patent life to compensate for certain Patent Office delays. For example, if there were excessive delays in prosecution caused by the Patent Office, or if you successfully appealed an Examiner’s adverse ruling, the time taken for appeal will be added to your patent’s life. As a result, just about every patent has a different life from every other one and you can buy software to help you make sure the Patent Office calculated your patent term correctly.

      A pharmaceutical patent can also have a longer term based on a patent term extension, which may be granted based on national laws which provide additional patent life to make up for some of the time lost on a patent during drug registration. Typical patent term extensions are for up to five years in the U.S. (called “Patent Term Restorations” in 35 USC 156) and other similar patent term extensions are available in major countries such as Europe, Australia and Japan. Canada is an exception and allows no additional patent term. Recall Canada strongly favors generics over innovative pharmaceuticals, so it is being consistent in not encouraging pharmaceutical research by refusing to provide extended terms for pharmaceutical patents.

      Patent term extensions do not necessarily extend the patent term for all of the claims of a patent. Instead, the patent term is extended only for claims covering the approved drug product. Thus a patent term extension will not keep competitors from filing for similar drugs to the innovator’s drug after the original term of a patent, but it will help protect the approved drug product from becoming a generic drug.

      An unanswered question is whether a completely different approved use for the same product would be covered during the patent term extension. The courts have not ruled definitively on this issue, but with the current trend of re-purposing older approved drugs for new uses, it is likely to come up soon.

      The FDA takes the position that any subsequently approved drug containing the same “active moiety” as the approved drug product is also entitled to the same patent term extension and indicates this in an online listing for all approved drug products called the Orange Book. (“Active moiety” refers to the portion of the drug molecule that is biologically active. Different salts, esters and hydrates of the same active drug contain the same active moiety.)

      Patent term extensions in the U.S. are allowed only for patents that cover the first approval of a drug product and must be filed in the U.S. within 60 days of the date that the drug product was approved. If you miss that date by even one day, only a private Act of Congress can help. In addition only one patent may be extended for an approved drug product and remaining patent life including extension cannot exceed 14 years. Details for obtaining such extensions may be found in the statute—just Google “35 USC 156”. There is one exception for veterinary drugs. A patent for a new veterinary drug product may be extended even if the same drug was previously approved for human use.

      In two recent cases, Photocure v. Kappos and Ortho-McNeil v. Lupin (Fed. Cir. 2010), the Court expanded the scope of patent term extensions by confirming eligibility for patent term extensions for new patents covering new approved products consisting of isomers or esters of drug compounds which had been previously approved.

      In Europe, there are similar rules for obtaining patent term extensions (called “Supplementary Protection Certificates”), but in addition, under recent European Court cases, one can obtain patent term extensions for patents covering a new use of an old drug or covering new combinations of old drugs. Those two important additional types of extensions are not available under U.S. law.

      Patents are typically filed first in one’s home country. In the U.S., the first to invent used to be entitled to the patent. Outside the U.S. the first to file is awarded the patent. Effective March 16, 2013 in accordance with the America Invents Act (AIA), the U.S. joined the rest of the world and now awards patents to the first to file.

      Previously, if there was a dispute between inventors in the U.S., it was resolved in a proceeding called an “interference” in which each party tried to establish it invented first. Interferences occurred in very few cases and were fought in the U.S. Patent and Trademark Office (PTO) in a formal procedure which was expensive, time consuming and contentious. They also could be settled using a private arbitrator if both parties agreed to do so, often with the understanding that the winner, whoever it turned out to be, licensed the loser. Outside the U.S. there is no need for such a procedure since the first to file is entitled to the patent, unless the second to file can prove the first to file had stolen the invention from him.

      The new U.S. rule on first to file thus puts the emphasis on prompt filing in the U.S. While the one year so-called “grace period” still remains, it is now personal to the inventor and generally does not cover third party disclosures of the invention made prior to the date of filing.

      One of the urban legends about patents is that the way for an inventor to prove his date of invention is to mail to himself a sealed envelope containing his invention disclosure to get a postmark establishing his date of invention. Some inventors tend to be secretive and even a little paranoid (in a good way) so they like this idea. The only problem is that such a procedure cannot legally establish a date of invention. This is because the patent laws provide that a date of invention can only be established if a third party, who is not an inventor, corroborates the date of the invention in writing.

      Today one does not even have to establish a date of invention as the first to file is awarded the patent regardless who invented first. But if you want to establish a date of invention, prepare a written disclosure of it and have a non-inventor read it and sign and date it. That establishes the legally required corroboration.

      The current trend in filing patents in the U.S. is

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