TM TM TM TM TM TM Pharmaceutical Trade Marks Group Sept 2015 Editorial: Milestones Each and every one of us has our own personal milestones, some small some huge and whilst few of us are subject to the scrutiny the United Certainly, tKingdom monarch was subjected to yesterday as she reached her own milestone, it is a common feeling that An annual small town festival iwe are all clocking up events which have just as much value in our lives as the years go by. an essential part of the human condition and provides the drive that is to be found in every walk of life, embodied both by heroes and ordinary people. Medical research and advances therein are the epitome of pushing back the boundaries. Epilepsy sufferersthe Commission and theto may well be the first P access pills created using the so-called 3D printing technology following the US Food & Drug Administration approval last August. Intellectual property lawthe past 25able toour continent has However, in must be years, adapt in such a changing environment. The planned trilateral symposium at m the end of October will allow the World Health Organisation, the World Trade Organisation and thetrade My heart goes out to World Intellectual Property Organisation to share data with the m intention of maintaining focus on the twin challenges of innovation and access in the medical domain. Between now and then, the Warsaw conference will no doubt provide delegates with an opportunity to take share PTMG milestones as we look forward to our first conference under the Chairmanship of Frank Meixner. I look forward to seeing many of you there. Vanessa Of course, Next month will see an important event for Intellectual tProperty specialists as the 20th anniversary of the implementation of TRIPS Agreement comes around. Younger members of the profession will have few memories of the beginnings of these crucial steps to enhanced co-operation and harmonised goals whereas for some, 1995 feels like yesterday. Without wanting Too often to appear too long in the tooth myself, the buzz back then when r pan-European rights were in their infancy is long gone. Cynics feel justified as the dreamed of level playing field still More the horizon. remains far off on surprisingly, in more recluse parts of that c d And yet, remaining positive that more can still be linguistic Indeed done is US Update New FDA Guidance Implicates Trade Dress Rights Jonathan S. Jennings, Pattishall, McAuliffe The U.S. Food and Drug Administration (FDA) may have inadvertently created potential intellectual property disputes with its 18 June 2015 release of its final Guidance "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules." (http://www.fda.gov/downloads/Drugs/Gui danceComplianceRegulatoryInformation/G uidances/UCM377938.pdf). This Guidance instructs generic drug manufacturers to minimize physical differences between a generic drug and its corresponding reference listed drug (RLD). The consequence of this Guidance may be to create more tension between branded and generic manufacturers over trade dress rights. In implementing this Guidance, the FDA worried "differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors." Guidance, 1. The main concern is that these differences make tablets and capsules more difficult to swallow. According to the FDA, more than 16 million Americans have difficulty swallowing, a condition known as dysphagia. The size and shape of a drug tablet or capsule can affect the ease of swallowing a drug. If the physical characteristics of a tablet or capsule make it more difficult to swallow, then the FDA fears consumers may be less willing to take their prescribed dosages. To combat this problem, the FDA recommends that generic drug manufacturers consider a tablet or capsule's size, shape, and other physical attributes during development. In terms of size, the FDA "recommends that generic oral tablets and capsules intended to be swallowed intact should be of a similar size to the corresponding RLD." Guidance, 4. In terms of shape, generic tablets and capsules should "have a similar shape or have a shape that has been found to be easier to swallow compared with the shape of the RLD." Guidance, 5. Finally, the FDA recommended that generic drug manufacturers also consider "tablet coating, weight, surface area, disintegration time, and propensity of swelling" when developing a generic drug tablet or capsule. Guidance, 6. This Guidance applies only to new drug applications and does not apply to generic drugs already on the market. As is always continued on page 3