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Researchers Develop Biochip for Measuring Glucose in Saliva

Schematic shows glucose molecules dancing on the sensor surface illuminated by different colors of light. Changes in light intensity transmitted through the slit of each plasmonic interferometer yield information about the concentration of glucose molecules in solution. (Image by Domenico Pacifici)

Late last year, Medtech Pulse reported that researchers at the University of Michigan (Ann Arbor) are developing a method for monitoring glucose levels using tears, not blood. Now, another group of researchers--this time at Brown University (Providence, RI)--are tooting their horn about a biochip that measures glucose in saliva. Using plasmonic interferometers, the chip could perhaps eliminate the need for diabetics to draw blood to check their glucose levels and could also be used to measure a range of other biological and environmental substances.

Relying on both nanotechnology and surface plasmonics, which explores the interaction of electrons and photons, the Brown engineers etched thousands of plasmonic interferometers onto a fingernail-size biochip and then measured the concentration of glucose molecules in water on the chip. Their results showed that the chip could detect glucose levels similar to those found in human saliva. Glucose in human saliva is typically about 100 times less concentrated than it is in the blood.

"This is proof of concept that plasmonic interferometers can be used to detect molecules in low concentrations, using a footprint that is ten times smaller than a human hair," said Domenico Pacifici, assistant professor of engineering and lead author of a paper published in Nano Letters.

To create the sensor, the researchers carved a slit about 100 nm wide and etched two 200-nm-wide grooves on either side of the slit. The slit captures incoming photons and confines them. The grooves, meanwhile, scatter the incoming photons, which interact with the free electrons bounding around on the sensor's metal surface. Those free electron-photon interactions create a surface plasmon polariton, a special wave with a wavelength that is narrower than a photon in free space. These surface plasmon waves move along the sensor's surface until they encounter the photons in the slit. This "interference" between the two waves determines maxima and minima in the light intensity transmitted through the slit. The presence of an analyte--the chemical being measured--on the sensor surface generates a change in the relative phase difference between the two surface plasmon waves, which, in turn, causes a change in light intensity. This change is measured by the researchers in real time.

The engineers learned that they could vary the phase shift for an interferometer by changing the distance between the grooves and the slit. In addition, they can tune the thousands of interferometers to establish baselines, which could then be used to accurately measure concentrations of glucose in water as low as 0.36 mg per deciliter.

"It could be possible to use these biochips to carry out the screening of multiple biomarkers for individual patients, all at once and in parallel, with unprecedented sensitivity," Pacifici remarks.

To further test the devices, the engineers next plan is to build sensors tailored for glucose and other substances. "The proposed approach will enable very high throughput detection of environmentally and biologically relevant analytes in an extremely compact design," Pacifici says. "We can do it with a sensitivity that rivals modern technologies."

Worst Medical Device CEOs, Plus the Best Bad CEO in 2011

Worst Medical Device CEOs, Plus the Best Bad CEO in 2011

Who deserves the most resounding "boo hiss?" Read below and see who gets our raspberry award. If I missed one, let me know in the comments section. I also wanted to point out that being a "bad CEO" can also mean acting with integrity. See who the best "worst CEO" is for 2011.

*The Bad

Stryker Chairman, President, and CEO, Stephen P. MacMillan

Stryker Corp. announced plans on Nov. 10 to lay off 5% of its worldwide staff (about 1000 people) to cut costs. MacMillan said the decision was a result of “a challenging economic environment and a market slowdown in elective medical procedures,” as well as the need to prepare for costs associated with the medical device excise tax—which doesn't go into effect until 2013. Irony of ironies, Fortune just named Stryker one of its Best Companies to Work For. (Photo: Jill McLane Baker, Kalamazoo Gazette)

Johnson & Johnson's CEO, William Weldon

Weldon hasn't really done anything—which is the problem. Sydney Finkelstein called Weldon out for being "complacent." I've had a few people complain to me that Weldon needs to retire. J&J has lost hundreds of millions in FTC advertizing, states advertizing, foreign bribery, and consent decree actions.Full Disclosure: MD+DI named J&J its manufacturer of the year for the bold moves the firm made in 2011. It just goes to show that a CEO isn't always the most important aspect of a company, but poor decisions from a CEO can certainly hurt it's reputation.

 

Poly Implant Prothese CEO, Jean Claude Mas

Poly Implant Prothese (PIP) was once the world's No. 3 maker of breast implants, but it went bankrupt and shut down in March 2010 after inspectors found it was using industrial-grade silicone in its implant  products. France ordered PIP's breast implants off the market in March 2010, but no charges have been filed to date. It is estimated that 300,000 women around the world could be affected. An involuntary homicide investigation has been opened over the 2010 death from cancer of a French woman with PIP implants. (Photo: Reuters)

 * Worst CEO who is Really the Best

Former Olympus CEO Michael Woodford

The company's first non-Japanese CEO was fired after two weeks for questioning $687 million in possibly illegal payments to acquisition advisors. An Olympus spokesperson insists that the inquiries had nothing to do with the termination. The company says that Woodford's aggressive management style didn't fit the culture. Nonetheless, Woodford's appointment and early termination exposed Olympus's legacy of embezzlement and fraud. Nearly $1.5 billion in possibly illegal payments were used to conceal losses on investments over the past two decades. (photo: Getty)

Heather Thompson

*Correction: The first version of this article incorrectly identified Mark Philip as the CEO of Stryker Biotech.

Weekly Vitals: The Power of Defective Breast Implants, Newt Gingrich vs. FDA, and More

This week in medtech, experts began to ponder the potential impact that the French breast implant scandal could have on U.S. regulation. The industry and its supporters often point to the quicker device clearance process in the European Union (EU) when criticizing FDA, for example. But the controversy that has erupted from a company's breast implants that leaked industrial silicone into patients has provided FDA and its supporters with a sizeable stock of ammo. "All the industry guys in the U.S. say, 'we should have access to these products much sooner, like in Europe,'" Carl Heneghan, an Oxford University teacher who has studied device recalls, told Bloomberg recently. "The flip side is, the European people are being used as guinea pigs." In addition to the breast implant controversy, presidential hopeful Newt Gingrich nabbed headlines and the interest of the industry this week when he stated that he wants to whip the agency into shape and create a "21st century FDA." Read about these stories and more in the weekly medtech roundup below.

Newt Gingrich Wants to Whip FDA into Shape

Newt Gingrich Wants to Whip FDA into Shape

If you missed Newt Gingrich's response to John King last night, check it out on You Tube.
This morning everyone was talking about Newt Gingrich getting “feisty” during last evening’s debate when CNN’s John King asked the former speaker of the House to respond to his ex-wife’s statement that he asked her, more than 10 years ago, about having an open marriage.
 
Even celebrity blogger Perez Hilton weighed in on Newt’s response. 
 
With that news out of the way, let’s talk about the GOP race for president and healthcare. There’s no question that Gingrich is a strong force in healthcare, and I think he has the best shot among the candidates at going toe-to-toe against President Obama in a healthcare debate (but don’t tell Rick Santorum I said that) . Not only has he been entrenched in healthcare issues, but he’s also brought FDA into the picture—namely, he wants to whip the agency into shape and create a “21st Century FDA” . However, he needs to more concretely outline what this means. Those of us in the medical industry already know that processes at FDA are flawed. How does Gingrich intend to fix it? To start, his Center for Health Transformation is tasked with finding ways to improve the regulatory process –and you can find out more about his intentions to fix FDA in a piece he wrote, along with former FDA commissioner Andrew von Eschenbach, for the Hill last year. 
 
Other Newt Notes:
  • He has made Modern Healthcare’s  “100 Most Powerful People in Healthcare” list every year since 2003, and last year he ranked #6.
  • Yesterday he released his 2010 taxes and guess what? He pays a much higher rate (31.7%) than other a lot of other people at his income level.
  • If you’re a Newt fan, you’ll be interested in the latest opinion piece by former U.S. Congressman Bill McCollum (R-FL) in today's Wall Street Journal

Covidien's CEO on the Necessity of Emerging Markets

At an AdvaMed-sponsoered event at the OneMed conference in San Francisco, Covidien CEO Joe Almeida described emerging markets as a "great attraction" for medical device companies. He, however, stressed the importance of knowing "where you are going to play in those markets. Being global doesn’t mean being all over the place," he said. "You have got have a concerted effort."

Such an effort requires a careful study of, for instance, what kind of business your firm plans on running abroad. If your firm plans on doing business in, for instance, China, carefully consider the type of hospital in which your products will be used. The type of hospital and city your products are used in has "huge implications." 

When doing business in emerging markets, medtech firms should also make sure that employees are sufficiently trained and distributors managed well enough to increase your odds of success. "There is a significant amount of work that needs to be done, he said. "We all learn from our failures. And you have got to learn quickly. And don’t be afraid of failures. Just be cautious when it comes to integrity and ethics."

For medtech companies, doing business in emerging markets is a must. "It’s like a 401(k) in the U.S.," Almeida says. "If you are an employee, you can’t afford not to participate," he explains. "In emerging markets, it’s the same thing. You can’t afford not to participate," he added. "You have got to do it. Just be cautious. The success comes with time. You don’t get an instant reward. If do, just watch out."

—Brian Buntz

File Early, File Often, and Other Intellectual Property Advice

David DykemanMD+DI has three new features dedicated to intellectual property. The first new feature is the first in a series on the impact of patent reform on medical device entrepreneurs. The first installment, titled "What Medtech Entrepreneurs Need to Know about Patent Reform," is a question and answer session with David Dykeman (pictured on the right), patent attorney and co-chair of the IP department at Greenberg Traurig LLP. The second installment is titled "What You Should Know about Patent Reform: The Post-Grant Review Process."

A second feature, titled "How To Develop A Strong Patent Portfolio," explains the importance of monitoring competitors' IP. 

The final new feature is named "Device Patents: Think Globally, File Locally," which focuses on the differences between the U.S. patent system and the rest of the world, some of which will persist after patent reform goes into affect.

—Brian Buntz

Blog: Can Obama Survive a Second Round of Healthcare Reform?

Blog: Can Obama Survive a Second Round of Healthcare Reform?

Last week, The Global Leaders conducted the 2nd Annual Healthcare Forum and Networking Reception with the express design of bringing innovators (medtech, biotech, pharma companies) and resources (investors and developers) together.

According to a story on QMED, conference cochair George Bickerstaff called on President Obama and the leaders of Congress to join an effort by others in business, education, government, and philanthropy to "work across disciplines to overcome obstacles" to solving the nation's healthcare crisis.

According to Bickerstaff,the crisis is defined by costs. "Costs are going up, access is still limited, and a there is serious disagreement within government and industry on how to improve healthcare and access," he says. "At current growth rates, healthcare expenditures will soon exceed 20% of the USA gross domestic product."

Bickerstaff says Congress and the President need to start by "agreeing on a multi-lateral plan that includes input from business, government, education, and philanthropy. The plan should include issues, actions, responsibilities, next steps, quantifiable measurements, and a sensible cost and funding approach.  The federal government should take a lead role in convening these leaders and encouraging open and transparent dialog, starting within the USA."

I have to ask: Does this industry want more healthcare reform? Or is the bitter pill of the device tax enough to make all reform propositions difficult to swallow?

And one more question: Will any president try to undo, revamp, or change healthcare? I doubt even Obama would want to try again.

In Case You Missed it: 

Op-Ed: Medical Device Tax Hampers Job Growth, Innovation

What the Privacy Act Teaches Us About The Device Tax

Sure, The Medical Device Tax Is Helping to Pay for Healthcare Reform—But Who Else Is Footing the Bill?

Seeking Scientists

The Dr. Paul Janssen Award Selection Committee is now seeking nominations of deserving individuals or a group of individuals for the 2012 Dr. Paul Janssen Award for Biomedical Research. Those interested in nominating a scientist can make a submission here.

Nominations will be accepted until February 15, 2012, and the Award will be presented in September 2012.

Each year, Johnson & Johnson awards the Dr. Paul Janssen Award to a deserving individual or group of individuals whose achievements in the field of biomedicine or medical technology have made, or have strong potential to make, a measurable impact on human health. The Award  includes a citation and prize of $100,000.  Past winners include Napoleone Ferrara, Anthony Fauci, Erik De Clercq, Craig Mello, Axel Ullrich, Marc Feldmann and Sir Ravinder Maini.

MX: Device Patents: Think Globally, File Locally

The United States entered a new phase of patent harmonization when the America Invents Act (AIA) was signed into law in September 2011. As a result of AIA’s passage, the first-to-invent standard unique to U.S. law will fade away. Under this standard two parties claiming the same invention were required to prove which of the parties was, in fact, the first to invent. Starting in March 2013, the U.S. will use a standard similar to the first-to-file standard used elsewhere in the world, and the party that files first will be granted the right to seek a patent with few exceptions.

Differences between patent processes used in the U.S. and the rest of the world will remain, however. These differences are relevant because patents are a local matter. A company cannot use a U.S. patent to stop production in China or sales in either Europe or South America because a U.S. patent’s protection generally ends at the border. If a device manufacturer wants to stop companies in China, Germany, and Brazil from using its technology, the manufacturer needs to have a patent issued in those countries.

To address these concerns a device company must know the answers to the three fundamental questions covered here: In what ways do patent systems differ? What strategies can be used to ease the costs of filing in multiple countries? How do different patent systems address medical technology inventions?

Similarities And Differences

To obtain a patent, a manufacturer must file an application with the responsible governmental authorities. Most countries examine the patent application to determine whether a fundamental threshold of novelty and inventiveness has been met. While certain countries, most notably South Africa, will issue a patent without determining novelty and inventiveness, such countries are a distinct minority.

The specific legal standards applied regarding novelty and inventiveness vary. European law and that of other countries apply an absolute novelty standard, i.e., any public disclosure of the invention before the filing of a patent application will prevent a patent from issuing. Certain countries except or exclude disclosures made within a certain period before filing. This period, referred to as a grace period, may extend from six to 12 months before the filing date.

In most countries, this grace period covers only the applicant’s actions and does not extend to the public disclosures of others. Under current U.S. law, a one-year grace period exists relative to the disclosures of the applicant and others. Under the AIA, a one-year grace period exists relative to the applicant’s public disclosures only, but the AIA also permits the patent application filings and public disclosures of others to be excluded from consideration if they occurred after the applicant’s disclosure. The U.S. standard, sometimes referred as a first-to-publish standard, thus remains unique relative to the standards applied in other countries.

A patent is not a self-executing form of protection. Rather, enforcement must be sought through the appropriate legal authorities. Again, experiences vary. For example, Germany has a remarkably swift and efficient mechanism for resolving patent disputes. On the other hand, many foreign companies continue to find China a difficult country in which to enforce patent rights, although this situation is changing.

Patent systems also differ in the options they offer for protecting a product beyond the traditional patent. It may be easier to obtain these optional forms of protection, in that a lower threshold of inventiveness may be required than for the traditional patent, or they may be issued without any examination at all. Typically, these forms of protection have a shorter life or other limitations that must be considered in deciding whether the protection will be adequate in a particular circumstance. Whether referred to as a utility model or an innovation patent, these mechanisms may provide patent strategies not available under U.S. law.

Think Globally, File Locally

International treaties and conventions have been established to level the playing field for domestic and foreign applicants. For instance, there are several conventions and bilateral agreements that permit a U.S. applicant to rely upon its U.S. filing date when determining novelty and inventiveness, as long as the foreign application is filed within one year. The availability of the U.S. filing date can be important, especially in a country where any prior public disclosure can prevent a patent from issuing.

Because of the costs involved, applying for foreign patent protection is a focused, targeted undertaking for all but the most valuable products that can justify filings in the U.S., Europe, and Japan. This situation exists as well in Brazil, India, China, Russia, and other, smaller countries. For example, while it is not necessary to prepare the patent application from scratch for each filing, each application will have a separate set of associated costs and fees. Moreover, many countries require that the patent application be translated into the local language and that correspondence with the patent office be conducted in that language, further adding to the filing costs.

One mechanism used to control the costs is the international, or Patent Cooperation Treaty (PCT), application. A PCT applicant can extend the time for making a final decision about whether to file a national application for up to 31 months in most countries. The additional time permits the applicant to determine the commercial viability of the product or method, research potential markets, and scout manufacturing locations that will assist in guiding the national filing strategy.

On the downside, the international application cannot mature into an international patent. At some point, the international application must be converted into national or regional patent applications in order to secure patents in selected countries. Moreover, while some of the costs of the process will be recovered when filing those national or regional applications, other costs cannot be recovered.

Another mechanism used to control costs is the regional patent application. The most well-known regional patent application is the European Patent (EP) application. Like the international application, the EP application will not result in a patent that is automatically enforceable in all member nations, although a movement is afoot to provide a patent enforceable throughout Europe. While an EP patent can be obtained through examination by the European Patent Office (EPO), for the time being the patent must be validated or nationalized in a selected member state in order for it to be enforceable within that country.

The examination of the EP application can be carried out entirely in English, which has the benefit of reducing the costs of the examination process for U.S. applicants. As a rule of thumb, if protection is desired in three or more European countries, the cost of filing and prosecuting an EP application followed by national validation may be less than the costs of filing and prosecuting national applications directly in those countries.

In addition, several patent offices have banded together to create work-product sharing arrangements intended to shave thousands of dollars off the cost of a multinational patent family and decrease the time for obtaining patents in the individual countries. The programs are referred to as Patent Prosecution Highways (PPH). The programs permit an applicant to use a first country’s determination to allow a patent application in order to expedite the examination of a counterpart patent application in a second country. At present, the United States has PPH programs with Australia, Austria, Canada, China, Denmark, the EPO, Finland, Germany, Hungary, Iceland, Israel, Japan, Mexico, Norway, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. There are also several programs that work in conjunction with the PCT process.

Disparate Treatment For Medical Devices

Medical technology, like computer software, is a topic on which countries have agreed to disagree. As a consequence, what may be patentable in the U.S. may not be patentable in Europe, for example. Even when a country might permit a patent to be issued, the patent may not be enforceable against all parties.

For instance, if protection is sought not on a medical device but on the method of carrying out a procedure using the medical device, protection may be difficult or impossible to obtain in Europe because European authorities generally consider medical treatment methods to be unpatentable. By contrast, methods of medical treatment are generally patentable in the U.S., but enforcement against an individual medical practitioner may not be possible. To illustrate why such limitations might be important, consider a well-known medical device that is in the public domain but for which a new method of use has been discovered. Under European law, this method may well be unpatentable; under U.S. law, the method may be patentable, but enforcement may be complex.

A trade agreement with South Korea that was recently ratified by the U.S. Congress exemplifies this disparate treatment of medical technology. Chapter 18 of the agreement deals with intellectual property rights, and, in particular, the issue of exclusions from patentability. In this regard, the agreement recognized only two categories of subject matter that may be excluded from patentability—inventions contrary to public order or morality, and “diagnostic, therapeutic, and surgical procedures for the treatment of humans or animals.” While this provision is not interpreted as a change in the U.S. position, it clearly highlights the sensitivity of the issue to authorities in other parts of the world.

In addition, consider a situation, not uncommon to many medical devices, where the basic structure and operation of the device are known early on, but the exact details of the commercial device may not be known for some time. Caution may suggest filing early, even though the exact details of the commercial device are not yet known, in order to prevent the applicant’s own activity from becoming a problem relative to the validity of any patent to issue from the application.

In the U.S., it may be possible to change or adapt the language of the claims later in the process to attempt to cover the basic device and then the developed commercial device. By contrast, European laws (as presently applied) may make later alteration of the claim language difficult, if not impossible. Moreover, because of recent changes to the European application process, it may be more difficult to maintain a European application pending in order to address later developments than is possible under U.S. practice. Consequently, differences in U.S. and European practices may lead to different levels of patent protection for the same product in different countries. This state of affairs makes it imperative that medical device manufacturers understand the differences in patent systems and formulate the proper strategies.

This article is intended to be informative and should not be interpreted as legal counsel for any specific fact situation. Views expressed are those of the author and not necessarily the opinions of Marshall, Gerstein & Borun LLP or any of its clients. Readers should not act upon the information presented without consulting professional legal counsel.

Paul Craane is a partner in the medical device group at Marshall Gerstein &Borun LLP (Chicago). He can be reached at [email protected]
 

MX: How To Develop A Strong Patent Portfolio

In the competitive medtech IP environment, a strong patent position may represent the lifeblood of a company. To attain that position, a medical device company cannot build its patent portfolio in a vacuum. Instead, a patent strategy must include a system to obtain information about competitors that can then be used to the company’s advantage. This system must track a competitor’s products so that the company can craft patents to cover those products, thereby building business leverage and increasing the company’s value. The system also must track a competitor’s patent publications so that the device company can avoid obstructive third-party patents, evaluate the need for licenses, and enter the market with the least amount of risk.

Medical device company executives should understand the importance of a strong patent portfolio as well as ways to obtain information on a competitor’s products and patent publications in order to devise strategies to best use that information. The path for achieving those goals is addressed below.

A Strong Patent Portfolio

As noted, medical device company executives should not underestimate the patent portfolio’s value as a business asset. Patents grant a right to exclude others from making, using, selling, or importing the patented technology. It is important to note, however, that patents do not grant the right to practice that technology, as another party’s patent may block that right. Patents therefore protect revenue and investments in R&D and regulatory activities by preventing or enjoining competition. In addition, a strong portfolio can prevent a competitor from receiving financial backing, forcing it to cease its business or to move in a different technical or market direction.

Patent portfolios also generate revenue through licensing fees, infringement litigations, and outright sales of patents. Often a patent portfolio covers more than one medical or nonmedical field outside the patent holder’s market. In such a case, the portfolio can generate a revenue stream through field licensing. In addition, venture capital groups and other investors scrutinize the patent positions of the device manufacturer and its competitors when making investment decisions. They look to see whether the product has patent coverage so that no one can copy it and that no patents cover the product, permitting the manufacturer to go to market. Competing financing decisions are often made based on which company has the stronger patent position.

Perhaps the most important aspect of a strong patent portfolio is its use as leverage. Because a successful medical device company inevitably will face patent obstacles from competitors, the company must have bargaining chips at its ready for cross-licensing or partnering, such as a strategic alliance, a joint venture, or other collaboration.

Obtaining Competitors’ Information

To help build leverage, a medical device company should track its competitors’ issued patents and published patent applications in both the U.S. and abroad. The company should generate a list of potential competitors, inventors in the field, and key technical words or phrases that may be found in the patent publications. The company then should perform regular searches of databases at patent office Websites, including the sites of the United States Patent & Trademark Office (USPTO) and the European Patent Office (EPO) as well as on www.google.com/patents and other commercial search engines. The patent publications may be downloaded from those sites. Regular searches of comprehensive, subscription-service databases of worldwide patent publications, including the Dialog and Derwent World Patent Index databases, offer results that can be automatically forwarded.

In addition to patent information, a company must track its competitors’ products. The best sources of that information include the competitors’ patent literature, as technology disclosed in a patent application often mirrors their product development; competitors’ Websites; trade shows, conventions, and other industry meetings; press releases, which may be monitored through internet services; and publications relating to clinical and FDA submissions.

Using Competitors’ Information

Armed with information about its competitors’ patents, a company should develop “defensive” and “offensive” strategies relative to the competition. Defensive strategies help a device company avoid a competitor’s claimed patent rights; offensive strategies help a company obtain patent rights in order to exclude competitors.

Defensive Strategies. A company should review its competitor’s patent claims for ways to avoid the claimed technology. Engineers and patent counsel should hold regular meetings in order to brainstorm ways to design around the claimed technology. These “design-arounds” themselves may be inventions worthy of patent protection.

If an alternative design is not an option, the company should attempt to obtain rights through a license or other purchase. Licenses can take many forms. They can be exclusive, nonexclusive, royalty-bearing, or non-royalty–bearing. They can also be field-restricted—especially if the technology is not the core of the patent owner’s market—or cross-licensed, if the device company has built patent leverage relative to the competitor’s product development.

Another defensive strategy includes instituting proceedings that challenge a competitor’s patent. In the United States, for example, such proceedings include patent reexamination and soon-to-be-available post-grant and inter partes review. In these procedures, a device company can request the USPTO to reevaluate the patentability of a competitor’s issued patent claims. This can be a less expensive alternative to litigating that matter in court. Many foreign patent offices have similar procedures. For example, the EPO has a procedure in which a company may oppose the grant of a European patent within nine months of that grant, also based on prior art. Therefore, it is important to closely monitor the grant of a competitor’s patents so that this option is not lost due to the passage of time.

Offensive Strategies. Using the information obtained about competitive products, a company should craft patent claims to cover those products. To do so, the company should review the disclosures of its applications pending in the patent offices in order to see whether those disclosures will support patentable product claims. The company also should have its engineers invent products based on the anticipated direction of its competitor and file new disclosures with claims focused on anticipated commercially significant features that block a competitor’s ability to practice in that direction. These strategies build significant leverage and bargaining chips.

The most aggressive offensive strategy is enforcement of your patent through an infringement action. As with other court actions, this option must be carefully considered because of its cost, risk, potential reward, and possible drain on company resources, including money and employee time.

Maintaining Profitable Markets

Medical device companies are at the forefront of innovation. Their technologies can save lives and improve the quality of healthcare for countless people. But maintaining success through product cycles can be difficult, especially when competitive and regulatory concerns plague the industry. Effectively obtaining and using competitive information to build a strong patent portfolio can help to reduce or prevent competition and maintain profitable market shares.
       
Les Bookoff is a patent attorney in Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC). He can be reached at [email protected]

Dinesh Melwani is a patent attorney in Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC). He can be reached at [email protected]