Generic Challenge:. Martin a. Voet

This is because patent holders in the U.S. can file follow-on patent applications based entirely (continuations) or in part (continuations-in-part) on the former patent application and get the benefit of the date of filing of the first-filed patent application for all common subject matter. If you file a string of patent applications as continuation (CON) applications or continuations-in-part (CIP) applications, the patent life for the last patent in the string is based on the filing date of the first patent application.

      Typically, a patent attorney will use a continuation application to try to get claims granted in a follow-on patent application when time for prosecution before the Patent Office has run out on the originally filed application or when only some of the claims he or she wanted were granted in the originally filed application (thus a second bite at the apple). A continuation-in-part application is typically used to add something to an already existing application, such as a new preferred formulation or some additional examples of compounds that were not disclosed in the original application.

      Also in the interests of harmonization, the U.S. joined the international community in publishing patent applications 18 months after they are filed, unless you ask not to be published and agree not to file the patent outside the U.S. If you recall the beginning of the chapter where the granting of a patent was a reward for disclosure of the invention, there seems something basically wrong with forcing the disclosure of the invention without first granting the patent! But that is now the law and the only way to get around it is to agree not to file abroad.

SUBMARINE PATENTS

      These new rules also solved a problem that had been invented by a man named Lemelson. Lemelson filed numerous patent applications in the 1950s on a variety of forward-thinking concepts and then he did an unusual thing. Instead of being in a hurry to get his patents granted, he took his time and re-filed the applications as continuation applications and kept adding subtle refinements to the claims and kept doing so for 40 years until, in the early 1990s when he finally allowed his patents to be granted, they covered important modern inventions. Since his patents were based on the old rules, he got a 17-year life from the date of grant.

      After his patents were granted, he asked just about every company in the U.S. for royalties and got them after suing many. He collected over 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.

PATENT TERM ADJUSTMENTS AND EXTENSIONS

      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.

HOW ARE PATENTS OBTAINED?

First-to-invent v. First-to-file

      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,