Pharmaceutical Patent AnalystVol. 1, No. 5 EditorialPatents and the US FDA’s definition of ‘cocrystal’: an ordinary and customary meaning?Jeffrey A LindemanJeffrey A LindemanJA Lindeman & Co. PLLC, 3190 Fairview Park Drive, Suite 480, Falls Church, VA 22042, USA. Search for more papers by this authorEmail the corresponding author at jeff.lindeman@jalindeman.comPublished Online:23 Nov 2012https://doi.org/10.4155/ppa.12.69AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: claimcocrystaldefinitionmeaningpatentPapers of special note have been highlighted as: ▪ of interestReferences1 35 U.S.C. §112.▪ Also see Article 84 of the European Patent Convention: “The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description.”Google Scholar2 Phillips v. AWH Corp., 415 F.3d 1303, 1312–1313 (Fed. Cir. 2005) (en banc).Google Scholar3 Thorner v. Sony Computer Entertainment America LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).Google Scholar4 Primos, Inc. v. Hunter’s Specialties, Inc., 451 F.3d 841, 847–848 (Fed. Cir. 2006).Google Scholar5 Visheweshwar P, McMahon JA, Bis JA, Zaworotko MJ. Pharmaceutical cocrystals. J. Pharm. Sci.95(3),499–516 (2006).Crossref, Medline, Google Scholar6 US FDA Co-Crystals Draft Guidance (2011).Google Scholar7 Aitipamula S, Banerjee R, Bansal AK et al. Crystal growth and design (polymorphs, salts, and cocrystals: what’s in a name? Cryst. Growth Des.12(5) 2147–2152 (2012).▪ Whether the draft guidance provides a helpful analytical framework for classification is currently being debated.Crossref, CAS, Google Scholar101 Bak et al.: US20080051453A1 (2008).Google Scholar201 US FDA. Regulatory classification of pharmaceutical co-crystals. Draft guidance. www.fda.gov/downloads/Drugs/.../Guidances/UCM281764.pdf (Accessed 5 August 2012)Google ScholarFiguresReferencesRelatedDetailsCited ByMulticomponent crystal compromising dasatinib and selected co-crystals formers: a patent evaluation of EP2861589B1Ritu Rathi & Inderbir Singh17 February 2022 | Pharmaceutical Patent Analyst, Vol. 11, No. 1Engineering and manufacturing of pharmaceutical co-crystals: a review of solvent-free manufacturing technologies1 January 2016 | Chemical Communications, Vol. 52, No. 57 Vol. 1, No. 5 Follow us on social media for the latest updates Metrics Downloaded 113 times History Published online 23 November 2012 Published in print November 2012 Information© Future Science LtdKeywordsclaimcocrystaldefinitionmeaningpatentDisclaimerThe views expressed in this article are those of the author and not those of JA Lindeman and Co., PLLC or its clients. The discussion by its own nature is general. Specific cocrystals and the circumstances surrounding them may, and are likely to, require further and other considerations. The article presents a legal discussion of patents and cocrystal patents in general terms. This discussion is not legal advice and, knowing that the legal landscape is an ever-changing one, should not be substituted for obtaining current legal counsel in regard to a specific cocrystal or fact situation.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download