Defensive use of publications in an strategy

Although it has been slow to catch on in biotechnology, defensive publication can be an important part of your comprehensive IP strategy.

Bill Barrett

search of the US database from the deal by disclosing an invention to the publications in light of a high-level A1996 to 2001 reveals almost 10,000 public. If the defensive publication pre- strategy will reduce the possibility of patents that cite the IBM Technical Disclosure dates the filing of the ’s patent strategic mistakes that could damage your Bulletin as prior art1. The Bulletin, which is application, the patent deal for that appli- IP position. published as a component of Research cation is out of balance: the patent appli- In general, publication should be con- Disclosure, is a mechanism for defensive cant has nothing new to disclose to the sidered when (i) the cost of patenting out- publishing. Citation of a publication, such as public, because the invention has already weighs the benefit of the patent monopoly the Bulletin, in a indicates been disclosed and is thus already pos- and (ii) the invention cannot be protected that the publication contributes to the state sessed by the public. Technically speaking, in a manner that is sufficiently secure to of the art against which the application is the successful defensive publication ren- support trade-secret protection. The flow judged. IBM uses the Bulletin to advance the ders the competitor’s invention obvious or chart shown in Figure 1 provides a useful state of the art, thereby raising the bar for its lacking in . framework for determining the disposition competitors’ patent applications. In other There is a caveat to the general principle of any specific invention. words, Bulletin publications force IBM’s that defensive publications destroy patent competitors to narrow their patent claims, rights. In the United States, a competitor Trade-secret versus patent protection helping IBM to reduce the possibility that its may overcome a defensive publication by Trade secrets protect against misappropria- competitors’ patent claims will encompass presenting evidence showing a date of con- tion of inventions that are kept secret, and IBM inventions. ception that precedes the date of the defen- not against independent discovery or Citation of such a large number of sive publication. However, this opportuni- reverse engineering. An invention is there- Bulletin articles strongly suggests that IBM’s ty is not available in most foreign jurisdic- fore a good candidate for trade-secret pro- defensive publication strategy is paying off. tions. As a result, defensive publications tection when (i) the invention embodies a © http://biotech.nature.com Group 2002 Nature Publishing Despite its successful use by IBM and a have their most predictable effect in the high degree of complexity and novelty that handful of other companies, defensive publi- destruction of non-US cation has been slow to catch on as an intel- patent rights. lectual property (IP) strategy in biotechnol- ogy. This article discusses the legal implica- When is publication a Is the invention Document tions of defensive publications, analyzes desirable strategy? a good candidate for protection strategic considerations for determining When considering a defen- whether to publish, patent, or maintain an sive publication strategy, for trade secret Ye s as a trade invention as a trade secret, discusses legal keep in mind that your protection? secret considerations for the preparation of defen- defensive publication can be sive publications, and discusses forums for used against you as well as No defensive publication. against your competitors. In the United States, when an What are defensive publications? inventor publishes his or her Do the costs of Document The heart of the patent system is a balanced invention, a one-year grace patenting for use as a deal between the government (representing period ensures that the outweigh defensive the public) and the patent applicant, and inventor’s patent rights are Ye s the benefits? publication an understanding of this deal sets the con- not immediately extin- text for a discussion of defensive publica- guished. Publication imme- tion. The deal requires the inventor to dis- diately extinguishes most No close a new invention to the public. In non-US patent rights, exchange, the government grants the however, even those of the inventor a temporary monopoly on his or inventor. A decision to pub- Document for her new invention. The purpose of a defen- lish is thus a decision to irre- preparation of a sive publication is to destroy the balance of versibly surrender potential patent application patent rights. Such an important decision should Bill Barrett is an intellectual property only be made in the context © Mark Sokoloff consultant at ipCapital Group, 400 of a comprehensive IP Figure 1. Flow chart showing the process for deciding whether an Cornerstone Drive, Suite 325, Williston, VT strategy. Viewing the poten- invention will be kept as a trade secret, patented, or made the 05495 ([email protected]). tial impact of your defensive subject of a defensive publication.

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would make independent invention by a Invention of a core technology with revenue products, it may be desirable to competitor unlikely; (ii) the novel aspects multiple commercial applications general- patent incremental inventions even when of the invention are not embodied in a ly provides the foundation for broad the incremental inventions are not embod- form that would permit the invention to be patent protection. For example, discovery, ied in a product, especially if the incremen- reverse engineered; and (iii) the invention expression, and sequencing of a gene asso- tal invention is an alternative that may be a is so securely protected that it is not likely ciated with a disease is usually sufficient to truly effective competitor. to walk out the door with a customer or an obtain a patent covering the isolated gene, Defensive publication should be pre- ex-employee. the synthetically produced gene, degener- ferred over patent protection only if the The classic example of a good candidate ate versions of the gene, the gene as a com- cost of obtaining a patent is not justified by for trade-secret protection is a break- ponent of a heterologous DNA sequence, the value of the patent monopoly. The clas- through manufacturing process that can- the gene as a component of a plasmid, a sic scenario for use of defensive publica- not be deduced from the product manufac- cell comprising the plasmid, and so on. For tions involves incremental inventions that tured. For example, a discovery that a pre- a commercially important gene, this are (i) covered by existing patent claims and viously patented drug can be synthesized potentially broad patent coverage is rarely (ii) not embodied in a product with poten- more efficiently using an unusual set of outweighed by the costs of patenting. tially long-term marketability. Consider the reagents and reaction conditions is a good Moreover, because genetic inventions are example of a novel gene. If a strong patent candidate for trade-secret protection. often subject to reverse engineering and portfolio exists with claims broadly cover- Patenting of such a process would require independent discovery, trade-secret pro- ing the gene and methods of making the disclosure of the invention to the public, tection may not be adequate. gene product using bacteria from the and the risk of infringement might not Consequently, a patent is the preferred Salmonella genus, new data that yet another provide sufficient deterrent to prevent oth- form of protection for such platform Salmonella species produces a properly ers from secretly using the process. inventions. folded gene product would be a good can- Nevertheless, such an invention should be Improvements to core technologies not didate for publication. If the invention is maintained as a trade secret only if the already protected by patents often form the not covered by existing claims, then pub- company is committed to taking the strin- basis of narrow, but valuable, patent pro- lishing the invention only assists competi- gent security measures necessary to main- tection. For example, consider the situa- tors in practicing the invention. If the tain the secrecy of the invention. tion in which a gene is publicly available invention is embodied in a product with In determining whether to maintain an and therefore not patentable. A novel long-term marketability, then the expense invention as a trade secret, it is important mutation that results in an improvement in of obtaining patent coverage is likely to be not to stumble over the “best mode” the gene product may open the door to justified by the extended patent protection. requirement. Patent applicants often like narrow patent protection for a nucleic acid Other examples of potentially effective the idea of patenting a basic invention with the improved nucleotide sequence. publications include the following: while retaining detailed information about Patent protection of narrow, incremental Uses of a core technology that are not © http://biotech.nature.com Group 2002 Nature Publishing some special aspect of the invention, such improvements is especially preferred when strong candidates for patent protection. as a superior method of making it. the patent’s claims will encompass a com- Even though they are not strong candi- However, the patent law requires the patent mercial product. If, for example, the dates, a competitor may convince the application to describe the best mode sub- mutated gene will form a component of patent office to issue a patent. An issued jectively known to the inventor for carrying your product, patenting is the preferred patent, even if it is invalid, is entitled to a out his or her invention2. Failure to include mode of protection. On the other hand, if presumption of validity, and expensive liti- the best mode can result in the invalidation the incremental invention (i) will not be gation may be required to overcome this of the resulting patent; thus, patent appli- embodied in a commercial product (e.g., presumption. cants should not attempt to retain as a trade the mutated gene results in a product that Inventions in filed applications. Most secret the best mode while seeking a patent is not as good as the current lead product) countries automatically publish patent on other, less effective modes of carrying and (ii) is already embodied in the broad applications 18 months after the initial fil- out the invention. In some circumstances, claims of your patent portfolio, then publi- ing. This results in an 18-month window an opportunity may exist to patent certain cation to prevent patenting by a competi- during which a non-US patent application aspects of an invention while retaining tor may be warranted. can be filed in a foreign country. Early pub- other aspects as trade secrets. However, Where an invention has potential long- lication of your own patent application decisions about such approaches should be term marketability, patenting incremental (i.e., before the 18-month publication) can made in light of a comprehensive strategy inventions embodied in products is advis- prevent this. Keep in mind, however, that in consultation with a patent attorney or able, even when an existing patent already the early publication can be used against agent who has been fully informed of all protects the invention. In such circum- your own subsequently filed non-US aspects of the invention. stances, patenting of incremental inven- patent applications as well. If the invention is not a good candidate for tions can help to extend the life of the Inventions in catalogs or other advertis- trade-secret protection, the next step is to patent coverage for the product. ing material. Catalogs, web sites, and other consider whether patent protection is war- Pharmaceutical companies often patent customer information all qualify as prior ranted. Patent protection is generally prefer- incremental inventions to extend the art. However, these items often are not able to publication, especially for the follow- length of patent coverage for a drug prod- searched by the patent offices because they ing categories of inventions: core or platform uct. Such incremental inventions typically are not in searchable databases. Publication technologies with multiple applications; include novel formulations, new methods of such materials in a forum that is readily improvements to core technologies where of administration, specialized drug deliv- searchable by patent examiners can the core technology is not already protected ery devices, improved dosage regimens, increase the probability that examiners will by patent; and improvements to patented and dosage forms combining more than find these publications and use them inventions where patent term is important. one active ingredient. Moreover, for high- against your competitor’s patents.

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How to write a defensive publication tion, consider including alternatives to the began publishing its technical disclosures The probability of executing a successful invention. Including alternatives to the in Research Disclosure, a defensive publish- defensive publication strategy is vastly invention will protect against competitors ing forum published by Emsworth Design, improved if the defensive publication strat- who wish to engineer around the published Inc. since the 1960s. Research Disclosure is a egy is part of a comprehensive patent strat- invention to generate patentable alterna- World Intellectual Property Organization– egy. As noted above, defensive publications tives. For example, if the defensive publica- recommended journal, which helps to relating to important company technology tion includes a gene sequence, consider ensure that it is on the radar of patent are best employed only where the company including language quantifying the per- examiners around the world. More than already has effective patent protection. For missible amount of variation in the 1,000 companies use Research Disclosure, this reason, it is often necessary to analyze sequence—that is, the amount of variation which publishes about 400 disclosures a the claims of your existing patents before that can be tolerated without destroying month, and Emsworth plans to begin publishing to be sure that they encompass the activity of the gene product. Your accepting publications through the the alternatives being described in your patent counsel can assist you in broadening Internet in the near future. defensive publication. In the absence of the impact of a defensive publication by A tempting forum for defensive publish- such protection, your defensive publication providing language commonly used in ing is the standard company web site. The may simply assist your competitor in engi- content of web sites is constantly changing, neering around your patent. Regularly however, and most do not include a scheduled reviews can be used to identify method of verifying the date and authen- and evaluate the value of each new inven- A tempting forum for defensive ticity of the publication. Additionally, web- tion, so that a decision can be made regard- publishing is the standard based searching is still not as accurate as ing whether to patent, publish, or maintain searching of traditional information data- the invention as a trade secret. If a decision company web site. The content bases. These problems reduce the probabil- is made to publish, the form and content of of web sites is constantly ity that a web site publication will be iden- the defensive publication should be care- tified and considered by patent examiners. fully considered. changing, however, and most IP.com is an Internet-based defensive According to the US Federal courts, the do not include a method of publishing company that seeks to address impact of a publication on is current online publication problems. controlled by the “enablement require- verifying the date and IP.com’s system electronically date-stamps ment.” To knock out a patent application, a authenticity of the publication. and authenticates each defensive publica- publication must “enable” the invention tion to ensure that its publications have claimed in the patent application: that is, the legal significance for the world’s patent sys- publication must “disclose every element of tems. Documents published by IP.com the challenged claim and enable one skilled patents to broaden the scope of an inven- become part of the text-searchable data- © http://biotech.nature.com Group 2002 Nature Publishing in the art to make the anticipating subject tion. Broadening the defensive publication base accessible to the world’s patent offices. matter”3. An assessment of the probable in this manner will reduce the risk that The disclosures are also published monthly value of a defensive publication should take others will patent related inventions; how- in The IP.com Journal to ensure compliance into account that the publication will not ever, surprising improvements or alterna- with accepted legal standards. prevent others from patenting aspects of the tives may still be patentable. As you broad- invention that are not enabled by the publi- en the scope, consider that you may need to Conclusions cation. In complex fields like biotechnology, describe experiments supporting the The word “publish” often brings fear into the where the efficacy of conceptual inventions enablement of those alternatives. hearts of patent attorneys, and rightly so. In is viewed as unpredictable, this application sectors such as the biotechnology and phar- of the enablement requirement means that Where to publish maceutical industries, intellectual capital is the defensive publication should provide a Arenas for publishing defensive publica- king. Patents are a prerequisite to protecting detailed protocol for obtaining the inven- tions range from traditional peer-reviewed some of the most valuable aspects of that tion and should generally describe empirical journals to online publications. intellectual capital and are thus a key to com- work demonstrating the validity of the Publication in peer-reviewed journals is a petitive survival. Ill-considered and untimely inventive concept. desirable option because the critical review publications can be patent poison.Yet, like any For example, consider the publication of afforded such publications validates their poison, publication can also be used as a a new gene sequence. Publication of the contents and is important to the advance- weapon. In attempting to avoid damaging sequence enables an ordinary molecular ment of science. The traditional require- their own patent potential through poorly biologist to make a nucleic acid having the ment of repeatability in peer-reviewed timed publication, companies and academic exact sequence of the gene. Publication of publications parallels the enablement institutions should take care not to overlook the sequence may not, however, enable an requirement, helping to ensure that the lat- the defensive use of publications. A successful- ordinary molecular biologist to use the ter is satisfied. The difficulty with tradi- ly executed defensive publication strategy can, gene in a specific gene-therapy application. tional journal publications is that submit- without the need for expensive patent prose- The publication would destroy the right of ted articles can take months to be pub- cution, help secure freedom to operate by pre- others to patent the isolated or synthetical- lished. Consequently, if timing is impor- venting others from patenting in the technolo- ly produced nucleic acid encoding the tant to the patent strategy, refereed jour- gy space described in the publication. gene, but may not destroy the patent rights nals should not be relied on for defensive of one who later succeeds in using the publishing purposes. 1. IBM Technical Disclosure Bulletin (http://www.ibm. nucleic acid in an unpredictable gene-ther- Before 1998, IBM maintained its own com/ibm/licensing/ibm_tdb/). 2. 35 USC §112. apy application. defensive publishing bulletin, the IBM 3. PPG Industries, Inc. v. Guardian Industries, Corp., To strengthen the impact of the publica- Technical Disclosure Bulletin. In 1998, IBM 37 U.S.P.Q.2d 1618 (Fed. Cir. 1996).

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