Obviousness, patent challenges

The validity of a granted patent may be challenged by a third party throughout the life of the patent on the grounds that it does not satisfy certain statutory requirements (for example, that it is not new or that it is obvious). Typically, the challenge may take place before the relevant patent office or before the national courts. 

Selection patents in the chemical arts can take many forms. Selections may be made from a prior art broader range of compounds or compound uses (as in the current example) but are not so limited. For example, selection inventions might also be made from prior art chemical processes where, for example, a broad temperature range or reaction time is disclosed and a later, narrower embodiment is discovered that provides a patentably distinct process. Selection inventions are also sometimes referred to as improvement inventions because the later selection may provide some unexpected result or benefit that helps overcome challenges to patentability based on assertions of obviousness of the later discovery. Obviousness challenges and rebuttals to obviousness challenges are discussed in more detail in Chapter 8. 

All of this preliminary material sets the stage for the crux of our present inquiry, What is obvious This is a key inquiry for patent law and one of the most crucial yet challenging concepts to understand because its meaning goes to the core of the definition of inventiveness. We have seen and reviewed novelty and should well understand its predicates. Unlike novelty, however, obviousness is a much more open-ended inquiry. Whereas novelty instructed us that we were limited to a single reference, obviousness can be based on information separately incorporated from... 

The next secondary consideration that the Court took up was near simultaneous invention. If two or more separate inventors almost simultaneously discover an invention, this can be regarded as secondary evidence that the invention is obvious. Mylan presented evidence that multiple other groups had synthesized levofloxacin within one year after the inventors of the challenged patent. The Court only assigned moderate emphasis to this secondary evidence, however, because Mylan provided no corroborating evidence as to the exact date of four out of five of the near simultaneous discoveries. This was an issue because one of the inventors of the patents in suit published on some of levofloxacin s properties and general resolution methods soon after they made their discovery of levofloxacin. Thus it was not clear whether the near-simultaneous invention from the other four groups was due to the obviousness of the invention at that time or because of the inventor s own disclosure.85... 

By the time that generic companies start working on any given product, several process patents may have been filed, thus restricting the choice of routes. Many of the obvious and commercially feasible routes are usually patent protected, and the processes disclosed in the earliest patents normally disclose connmercially unworkable processes. In addition, solid-state characteristics such as different polymorphs and solvates, particle sizes, and bulk densities of APIs and key intermediales are protected extensively by patents. Therefore, the process development chemist faces a twofold challenge (1) identify a route that is free of any patent issue, and (2) ensure that the product obtained by using such a process is also free of any patent issues related to polymorphism, solvates, and so on. 

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