The medical devices industry has seen its fair share of large patent lawsuits in recent years, with settlements and fines ranging from tens of millions to billions of dollars. Some recent examples: Medtronic, Inc, paid $400 million to Abbott Laboratories to settle a lawsuit over stent and stent delivery systems, and Boston Scientific Corp agreed to pay Johnson & Johnson $1.73 billion to settle two stent-related lawsuits.

Such suits often result from these simple, yet potent, mistakes committed in the early stages of product development:

• Lack of proper competitive intelligence owing to improper patentability and an inadequate prior art and infringement search. An example: the recent row over the ‘drug eluding coronary stent’ patent US 4739762 (Cordis Corp vs Boston Scientific and others).

• Lack of coordination between various departments leading to the R&D working in isolation of the legal department that forms the claims of a patent document

The above mistakes are absolutely unwarranted. Yet, the medical devices industry is fraught with active patent filings and high patent pendency rates (time between patent filing and when it's granted, which averages over four years).

Consider companies introducing medical devices to the market. They must ensure that they are not infringing on any of their competitors' intellectual (IP) property. In other words, they must be certain that they have the “freedom to practice” their invention). They must also protect their own inventions with patent filings to give them a competitive advantage in the marketplace. If they are licensing technologies from their partners, they have to “vet” those technologies as well.

All of these actions need to occur well in advance of the product development cycle. If a company discovers late in the product development cycle that its concept may infringe on a competitor's patents, its multimillion dollar product development investment would go waste.

Major medical devices companies are beginning to embrace a more proactive intellectual property strategy. This strategy has multiple elements:

• Patent landscaping is the creation of a comprehensive review of all patents specific to the technology of interest in which key players are identified and patenting trends summarized as shown below. This information should be organized in a searchable fashion and shared with engineers, managers, and patent attorneys involved in all technical and legal decision-making

• Patent clearance involves searching the key concepts of the new product technology thoroughly and reviewing all existing patents and publications to ensure that the invention will not infringe on other patents.

• Patent monitoring refers to the tracking of all new patents and publications on an ongoing basis (since patent applications are not made public in the U.S. until 18 months after their filing) to ensure that there are no “surprises” that were missed during patent landscaping or the clearance search.

The ins and outs of ‘producteering’

Product + Engineering = Producteering. Those companies that are best when it comes to producteering know the importance of thinking outside the box in order to arrive at solutions to tough challenges. Here are some ways producteering is practiced:

• Build vs buy decision-making

  Reaching an informed build vs buy decision often requires a detailed technology landscape report consisting of data culled from patent, non-patent, product literature. For example, actionable information enables the IP departments in companies to identify a foreign academic spinoff startup with strong IP and advise its business development counterparts to make an offer to purchase the target company or build it in-house for its R&D team to analyze.

• Throttle vs invest strategies

  The nature of competitive intelligence has awed many organizations looking for meaningful investments. For example, a well crafted IP, technology, manufacturing and market trends database can help in a decision to hold off on investing in huge plants and to build smaller plants instead. Also, abstract intelligence such as capacity glut and slackening of demand also can be obtained with marked accuracy.

• Geographic factors

  Patent-to-product mapping showing remaining patent life periods can be vital in determining the viability and appropriate time to market in a specific geographical market.

  Taking all this into consideration, the Dolcera Dashboard — an interactive Web 2.0 tool used to review large quantities of patent, scientific, and product literature in an aggregate fashion — is helping organizations devise compelling IP strategies via the following:

• Collaboration platform

  The dashboard's Web 2.0 platform enables collaboration among geographically distributed teams within an organization. Also, the collaboration is further enriched by the rating and tagging reference utility features.

• Knowledge console

  The dashboard enables the organization of complex mind maps and the relevant patents belonging to each category. This simplifies competitive analysis with respect to each genre. The dashboard also accepts user inputs (eg patent numbers) to facilitate patent data customization and organization.

• Patent database integration

  The capability to integrate with popular patent database to enable search and store operation inside the console enables use of the dashboard by multiple departments within an organization.

• Data filters

  Enhanced filters facilitate patent data analytics (eg. filter patents by country codes, IPC classes, filing date, etc.)

Learn more …
from exclusive Web articles by pulling up MedicalDesign.com and selecting the Engineering/Prototyping tab (of course, identify the one of eight tabs under which the article is to appear) at page top.

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