Secrecy, patents

The practical role of trade secrets in the drug development and discovery industry may, of course, be significantly limited by the public disclosure of information and data required by the FDA approval process, publication of pending patent applications, and the large number of groups working in this area, who may independently discover the secret. Information or data that the FDA publicly discloses or otherwise makes available to the public loses its status as a trade secret. However, where trade secret protection is not available because of the inability to maintain secrecy, patent protection may be the only viable form of protection available. 

Levin8 prepared a survey for research and development R D heads in which they were asked about the effectiveness of different methods for protecting products and processes patents, industrial secrecy, rapidity in the learning curve and sales efforts. The results showed that product patents were considered to be more effective than process patents, but in general all the other methods were regarded as more effective than the protection provided by patents, in a general survey that was not addressed to any particular sector. 

Novelty, in the patent law sense, is not required for a trade secret. W. R. Grace Co. v. Hargadine, supra, 392 F.2d, at 14. Quite clearly discovery is something less than invention. A. O. Smith Corp. v. Petroleum Iron Works Co., 73 F.2d 531, 538 (CA6 1934), modified to increase scope of injunction, 74 F.2d 934 (1935). However, some novelty will be required if merely because that which does not possess novelty is usually known secrecy, in the context of trade secrets, thus implies at least minimal novelty.. . . ... 

Employee Patent and Secrecy Agreements, Studies in Personnel Policy, No. 199, Nat. Ind. Conf. Board, Inc., New York, 1965. 

O Meara, Patent and Secrecy Agreements, National Industrial Conference... 

Although we are obliged not to disclose too much about the data already obtained by Otsuka, owing to the secrecy requested by the patent agreement, we may claim that SOAz does not induce any nephrotoxicity or hepatotoxicity or cardiotoxicity. 

But sequential innovations often add much more to social value as well as to reduce cost through process and follow-on innovations (Sinclair, Klepper, and Cohen 2000). With an innovation in the public domain, firms may have a lower incentive to improve upon it. But in the case of vaccines, a follow-on innovation may also qualify for a new round ofprizes. The case of cost-saving process innovations may be a concern, but for these types of innovations patents have been shown to be less important than other mechanisms such as secrecy (Walsh, Arora, and Cohen 2003). 

The secrecy of the manufacturing processes is maintained partially by discouraging outside investigators through patent protection. However, the most important aspect of the protection is probably that examination of the finished catalyst offers little information on how it was prepared and no information on why a particular preparation procedure was used. 

A quick review of some of the material presented in Chapter 2 In most cases, patent applications filed after November 29, 2000, in the United States (and the rest of the world) are pubhshed approximately 18 months after the earliest application in the chain was filed. However, if the application is no longer pending (e.g., abandoned) or subject to a secrecy order, it will not be pubhshed. Also, an applicant for patent in the United States can request that the application not be pubhshed but the applicant must certify that the application has not or will not be filed in another country that requires publication 18 months after application. 

There are many polymer chain modification reactions of different types that have been carried out on polymer melts processed in single and twin rotor extruders. This activity, (4-6) in the analysis of polymerization reactors, driven by market forces seeking to create value-added polymers from commodity resins, started in the mid-1960s in industrial research laboratories (7). Indeed much of the early work is to be found in the patent literature.1 Although in recent times more publications, both industrial and academic can be found in the open literature, there is still a good deal of industrial secrecy, because the products of reactive polymer processing are of significant commercial value to industry. Below we will deal briefly with two important examples of such reactions. 

The generation of targets aimed at cost reduction is an economics driven process. The targets will most likely be specific to the company s operation, since no two manufacturing plants are exactly the same, even within the same country and economic constraints. The development work will also be based on a consideration of the company s own internal information. This is because process secrecy and confidentiality means that there will be little, if any information in the external literature about a competitors process, other than the broadest outlines given in a typical process patent. It is unlikely that R D will be able to make a detailed analysis of the strengths and weaknesses of a competitor s processes in the same way that they can of their products, samples of which are available commercially. 

The information provided in this chapter is limited not only by matters of space and relevance, but also by an additional reason. A number of biotechnological companies and institutions are working in the development of new cultivars with altered starch compositions. Research done by, or on behalf of, commercial enterprises generally is not published in refered journals and is kept secret by the companies until applying for a patent. This policy of secrecy clearly slows down the dissemination of scientific information and deprives scientists of the very helpful peer review (affecting negatively the quality of the research). This tendency, unfortunately, is likely to become more dominant. Limited information is sometimes offered in scientific conferences, but hard data are often missing. 

Huntsman Also called the Crucible process. A method for purifying blister steel, made by cementation, by melting it in a closed clay or graphite crucible and pouring the melt into a cast iron mold. Developed by B. Huntsman, a clockmaker, around 1740, initially in Doncaster and later in Sheffield, UK. The process was not patented but was operated in secrecy for some years. It was subsequently widely operated in the UK, Europe (where the combination of this with the cemen-... 

REVIEW OF CONSERVATION EFFORTS. Conservation efforts are often conducted by individuals and groups who do not release details of their work even when protection of forthcoming patents is not involved. Such confidentiality is unnecessary and is, indeed, suspect (51). This unwarranted secrecy must not accompany the conservation efforts for such a national treasure as the tomb of Nefertari. Therefore, publication of detailed conservation work in respected peer-reviewed journals is mandatory. Not only will this well-accepted scientific practice result in more responsible conservation work, but it will ensure international deliberation, which can lead only to a more rigorous study and evaluation of optimum solutions to conservation problems. 

You are too naive, his friend retorts. He adds that American politicians were already advocating secrecy, aimed at locking out the Japanese. Eventually, both the spy and the profit-hungry businessman get their just deserts the businessman finds he cannot patent a trivial superconducting application and the spy falls into the arms of a pretty girl. 

The criticism is correct when it accuses Wollaston of retarding the progress of investigation into the production of malleable platinum, for that was his prime motive for secrecy. He was well aware that his process was not novel enough to be patented, and could easily be mastered by a good chemist. As Berzelius wrote after learning of the process (23) ... 

GAB2 Patent and Trademark Office delays due to interference, secrecy order, or successful appellate review (where BPAI or court reverses determination of patentability of at least one claim [allowance by examiner after a remand from BPAI is not a final decision]. GAB2 was also the basis of PTA under URAA, but for a maximum of five years, AIPA removes five-year limit. 

GABS Patent and Trademark Office fails to issue a patent within three years excluding time consumed in RCE, secrecy order, interference, or appellate review (whether successful or not), time consumed by applicant-requested delays (e.g., suspension of action up to six months for "good and sufficient cause," up to three-month delay request at time of filing RCE or CPA, up to three-year deferral of examination requested by applicant. Filing an RCE for an application filed on or after May 29, 2000 cuts off any additional PTA due to failure to issue patent within three years, but it does NOT eliminate PTA in GABl and 2. 

From the start. Van Ameringen had created a highly focused company, a leader in U.S. markets. Moreover, after 1958 the firm became a highly successful competitor in international markets. But, unlike the other enterprises described in this chapter, its barriers to entry lay not in scale but in the quality of its products, protected by secrecy, by a stream of improved products, and by patents. 

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