Patents for Medical Devices and Pharmaceuticals – Summary of Key Differences
Introduction: Members of the Global Medical Technology Alliance (GMTA)i are often asked how patents are applied to medical devices, and thedifferences between their use in the medical device and pharmaceutical domains. Although not exhaustive, this paper is intended to outline the key
differences for the general reader. It does not cover trademarks, copyright, domain manes, or technical knowhow and trade secrets, nor does it
cover differences in patent regimes in different countries.

Summary of Key Differences

Nature of product: There is a much greater number and diversity of 
medical devices than pharmaceuticals. Medical devices are typically
based on mechanical, electrical, information technology and systems
engineering, and stem from ideas typically generated in a clinician’spractice. Pharmaceuticals are based on chemistry, biotechnology
and genetics, coming from an R&D laboratory.
Patent coverage: Many more fields of art contribute to thedevelopment of a medical device as compared to apharmaceutical. Medical device patents are typically directed to thestructure, function, and methods of using the device. As a result,many more patents are used to cover a medical device than apharmaceutical.

Patent types: Patents for medical devices cover many different
structures, processes, methods and components (configured tooperate in a certain way), including alternative embodiments. Thistypically leads to many patents covering a medical device, comparedto 1-2 patents covering a pharmaceutical.
Alternate designs: “Design-arounds” are common for medical
devices, but not for pharmaceuticals. The prevalence of alternate
medical device designs typically precludes an exclusive position in
the marketplace.
Improvements and product life-cycle: The commercial life of a given
type-model of medical device is normally short (~24 months), muchless than the duration of the patent (20 years fromfiling). Pharmaceuticals typically remain on the market during theentire life of the patent and beyond.

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Medical Devices

Pharmaceuticals



Nature of product: A single medical device may comprise a variety of 
technologies from many different fields of art such as materials
science,electricalengineering,mechanicalengineering,semiconductors, computer software, wireless communications and soforth. They are constructed to deliver one or more capabilities relating
to diagnosis, therapy delivery and/or surgical navigation. The
underlying ideas often originate in a clinician’s medical practice. The
arts from each field must be applied together to produce a functioning
device for an intended purpose.

Nature of product: Pharmaceutical products are based on the fields ofchemistry, biotechnology, and genetics. The function of apharmaceutical product is typically fulfilled by a limited number ofmolecules within a structural class of molecules. To be effective, thechemical composition must be maintained within narrow boundaries
and does not permit many alternatives or variations.

Patent coverage: Due to the wide variety of structures and 
technologies embodied, many different patents typically cover a
single medical device. For example, a pacemaker will typically haveseparate patents covering the housing, battery, capacitor, electricalcircuit, communication system, software programs for therapy
delivery, sensing and detection, lead structure, and electrical system(electrodes and sensors) on the lead. Subsequent generations ofsimilar devices will typically use the material disclosed but notclaimed in some of the same patents, and procure a patent on theadditional structures and technologies, reflecting advances in thestate of the art.
Patent types: The ultimate effectiveness and benefit of a medical device is dependent in part on the skill of the clinician using orimplanting the device. In this regard, medical device patents may
cover method of implant, installation, surgical navigation, placement,adjustment, calibration, and adaptation to particular patients.
Specifically, medical device patents also may have method claims
such as method of manufacturing, method of implanting, method ofoperating, method of initiating etc. While method claims are notgenerally allowed in most foreign jurisdictions, they are broadly
asserted in the United States.

Patent coverage: There are normally very few patents for mostpharmaceutical products. Since there are a finite number ofmolecules that may be used to elicit a desired biological response
and clinical outcome, competitors may be effectively excluded frommaking the pharmaceutical product by a single patent covering theclass of molecules that comprise the pharmaceutical product. Oncethe patent expires, or is no longer applicable, it is possible forcompetitors to produce “generic” copies.

Patent types: Most pharmaceutical products are either ingested orintroduced into the body directly and therefore constitute therapies
themselves-not
diagnostics
ortherapydeliverysystems. Pharmaceuticals utilize the body as a natural delivery
system. Accordingly, with very few exceptions, pharmaceuticalpatents do not have method claims regarding delivery
mechanisms. Further, pharmaceutical product patents are usually
directed to the structure of the molecules themselves or methods ofmaking or purifying that compound.

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Alternate designs: A medical device will typically have many structural and functional variations, different components and/ormaterials. Other devices that deliver the same or similar functionality
can often be designed and built in countless ways. As a result, thereis no such thing as a “generic” medical device. Competitor
companies are typically able to design around patented structure andfunctionalfeatures
tocreateaproductwithsimilar
operational/functional characteristics. While patents for medical
devices may be directed to many different embodiments, it is very
difficult in practice to predict all conceivable ways in which competitor
companies could work around a design. A successful redesign often
cuts short the effective life of a patent by rendering it unenforceable
against the new design. Thus, over time, it may be possible toincorporate features and designs from patents that have expired or
are no longer enforceable in new devices. This allows producers todevelop competitive devices. While there may be litigation overoverlapping patent claims, this typically occurs only in the UnitedStates, Europe and a few other developed markets.

Alternate designs: Pharmaceutical products generally do not lendthemselves to “design around” efforts and do not require several
patents covering variations or alternative designs.
Once a key
pharmaceutical patent is expired, it will be possible for othermanufacturers to make “generic” versions of the same
pharmaceutical.

Improvements and product life-cycles: As new technologies continue to develop, each field of art may implement these new technologies,
which make iterative product improvements possible on a frequentbasis. As a result, medical devices have a short commercial lifecycle, typically on the order of 18-24 months. Each new component
or improvement (with the new technology implemented in theproduct) may be individually patentable. Accordingly, a single
medical device may be covered by hundreds of patents.

Improvements and product life-cycle: Pharmaceuticals typically havea long commercial life-cycle (10-20+ years), during which they do notundergo significant changes.

iFor more information, refer to http://www.globalmedicaltechnologyalliance.org/

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