Invisalign's Align Technology Update on Litigation wtih Ormco

Align Technology Provides Update on Patent Litigation with Ormco Corporation

SANTA CLARA, Calif., July 21, 2009 -- Align Technology, Inc. (Nasdaq: ALGN) today provided an update on the a lawsuit brought by Ormco Corporation (Ormco) against Align Technology, Inc. (Align) in the U.S. District Court for the Central District of California (District Court), which was tried by jury June 9 through June 25, 2009.
As previously disclosed, on June 26, 2009, the jury delivered a verdict against Align. Ormco alleged that Align infringed claims of Ormco’s 6,616,444 patent. Align claimed non-infringement, invalidity, as well as unenforceability of the patent and equitable defenses. The jury found the claims asserted by Ormco in the 6,616,444 patent to be infringed and valid. The jury also issued an advisory verdict that Ormco did not engage in prosecution laches or unclean hands, equitable defenses raised by Align. The jury only determined liability. Any monetary damages will be determined in a later trial, which has not been schedule, but would likely occur in early 2010. The jury verdict does not preclude Align from selling its Invisalign System. We have not accrued any liability for the judgment related to the Ormco litigation as such amounts are not reasonably estimable at this time. This is due to a number of factors, including: that the Court has not yet entered judgment; that discovery regarding possible damages is a lengthy and time consuming process involving testimony of experts and has not yet begun; and that determining a reasonable royalty rate is highly fact specific and there are many complicated factors to consider in this case.

The Court requested and has received briefing on the equitable defenses raised by Align and is expected to rule on the equitable defenses later this week. Align believes the facts and the law do not support the jury’s findings of infringement and validity and therefore has filed a motion for judgment as a matter of law on all issues seeking to set aside the jury’s verdict of liability. The Court has set a hearing on our motion for August 3, 2009, after which the Court is expected to enter judgment. Depending on the judgment entered by the Court, we may file various post-trial motions and if unsuccessful, we intend to appeal the liability decision and request a stay of the damages phase of the case pending appeal.

On July 13, 2009, Ormco filed a motion for permanent injunction against Align seeking to enjoin the sale of the Invisalign System through the January 2010 expiration of the 6,616,444 patent, as well as other injunctive relief including the destruction of all material, including software, created by Align from September 2003 to the present, the discontinuation of certification programs and the decertification of doctors certified from September 2003 to the present and the destruction of sales representatives’ records developed during this time period. The Court has scheduled a hearing on the motion for permanent injunction for August 17, 2009. Ormco seeks unusual injunctive relief that we believe is unwarranted and not supported by the law or facts of the case. Align will contend that an injunction would cause irreparable harm to Align, its employees and those doctors who include Invisalign as a large part of their practice, and would interrupt patient treatment and services currently underway. In addition, a balancing of hardships weighs heavily in Align’s favor as the issuance of the injunction would require Align the cease the sale of its sole product, the Invisalign System, while the denial of the injunction does not harm Ormco. Finally, any harm Ormco claims to have suffered would be sufficiently compensated by money damage. For these reasons, we strongly believe that Ormco’s motion for a permanent injunction should be denied and we will vigorously oppose the motion. In the unlikely event that the Court grants a permanent injunction, we would immediately appeal to the Federal Circuit Court of Appeals and seek to stay the injunction.

Ormco Patent Litigation Background Previously Disclosed:
Align has had ongoing patent litigation with Ormco, since 2003 when Ormco sued Align for patent infringement and Align won a sweeping summary judgment. Ormco appealed that decision and in August 2007 the Federal Circuit Court of Appeals ruled that 86 of Ormco’s 92 claims (related to 6,616,432, '243, '861 and '444 patents) were invalid and not infringed by Align. Ormco pursued the six remaining claims, which relate generally to a process of gathering and organizing tooth data, in the lawsuit against Align in the U.S. District Court for the Central District of California.

Our Patient Reviews: Richmond Hill Invisalign, Markham Braces, and Thornhill Orthodontics Experiences

At Markham Centre Orthodontics, Dr. Tam and his team of professionals understand that everyone expects straight teeth and a beautiful smile from their orthodontic treatment. We also know that there are various motivations and a lot of choice for seeking orthodontic care in Markham and Toronto. That is why the success of our work is measured not only by providing you with a beautiful smile, but with a wonderful experience along the way, that you can share with your friends, family, and colleagues.

We thank our patients for providing us with the following online reviews from our website. It is extremely gratifying for us to receive affirmation, from both adults and teens, that we are providing the wonderful care and environment that we strive for. We look forward to continuing to be your choice for Invisalign in Richmond Hill, braces in Pickering, and orthodontists in Markham. Contact us at 905-477-7750 to schedule your complimentary consultation!



Braces and Invisalign Reviews of Dr. Jason Tam and Markham Centre Orthodontics

I never thought I'd have straight teeth because I just will not wear braces and needed some serious movement. Doctor Tam plotted out, what seemed impossible, a treatment using Invisalign and he moved a tooth from behind my main row of teeth to the front. It's been a long road (2 years+) but my teeth are straight and awesome! And no braces! I can't overstate how impressive this Dr.Tam, his staff, and the facility are. If you need orthodontics and are in the Markham area do yourself a favour and at least check MCO out.
-Rajesh K.

I have been a patient of Markham Centre Orthodontics for nearly two years and just recently had my braces removed. Working with Dr. Tam and his team has been a pleasant and an enjoyable experience. Markham Centre Orthodontics offers a modern and contemporary style, as well as a well kept and clean environment. This clinic is very welcoming and is great for patients of all ages. I am very happy with my results, and would recommend this clinic to anyone in need of orthodontic treatment.
-Erin L.

I have been with MCO for almost a year, and I've been seeing great results. The customer service is amazing and Dr. Tam and his team make you feel right at home. I would recommend Dr. Tam to anybody who's looking for a perfect smile!
-Lyshelle B.

I had a great experience with Markham Centre Orthodontics. I wanted the invisalign treatment done as soon as possible and they made driving from far away worth it. The facility is modern and clean. The MCO staff addressed all my questions and concerns and helped make the procedure quick and easy. In less than a year my teeth are straight. I recommend getting the invisalign treatment here. Thank you MCO. -Cory O

I cannot say enough good things about Dr Tam and his staff. They are an excellent team and the facility is state of the art! If you need braces, MCO is the place to go! Being an adult, getting braces was one of those things that I wanted to get done for a very long time but was afraid of the process. After going for consultations at several other orthodontists with no success, my dentist recommended Dr Tam. I immediately felt comfortable with him. The initial consultation was very thorough with xrays, pictures and assessments done on the spot. When it came time to get my braces on, I was pleasantly surprised that Dr Tam had a more efficient way of getting the brackets on that took little time and wasn't as painful as I thought it would be. All procedures are explained to me and I was told what to expect every step of the way. I have had my braces for 15 months now and the progress has been amazing. I actually started seeing dramatic results at my second visit!
-Pauline T.

Pros and Cons of Invisalign- Richmond Hill Invisalign and Scarborough Invisalign Teen Premier Provider

As a Greater Toronto Invisalign Premier Provider office, we see patients interested in Invisalign from Richmond Hill, Scarborough, North York, and Unionville. Being in the top 5% of all Invisalign providers, our patients are willing to see us in Markham. We are often asked about the pros and cons of Invisalign braces vs traditional metal braces or clear ceramic braces. Here are some of the pros and cons of Invisalign in Thornhill, Markham, Pickering, Ajax, and Whitby. Should you wish to schedule your free Invisalign consultation, please call 905-477-7750 or visit www.markhamortho.com for more information.


Pros:

Removable- easier to maintain oral hygiene, can eat what you want, take out for sports and playing instruments

Virtually Invisible- more aesthetic than metal braces and clear braces so no one need to know you are undergoing orthodontic treatment

Comfortable- no wires or brackets against the inside of your mouth

3-D simulation- video gives patient an idea of the treatment goal prior to starting treatment and may be a motivating factor

Fewer Emergencies- no poking wires or broken brackets

FDA approved material- safe and no concern over metal allergies

Treatment of choice- for certain malocclusions, it may produce a better result in a shorter amount of time

Straight Teeth, No Braces- many patients wish to align their teeth, would never get fixed braces, but would use Invisalign


Cons:

Require excellent cooperation- if they aren't worn as directed, the teeth won't move

Require removal for eating- take aligners out for anything but water, followed by brushing or flossing, before replacing aligners

Cost- generally more expensive than braces (not the case in our office due to Invisalign volume but will differ by provider)

Transient lisp- whether with brackets or aligners, there is an adjustment period and a slight lisp should be expected at the beginning

Changing treatment- treatment set once the ClinCheck is accepted. Direction of treatment changed by new impression and starting again

New aligner every 2 weeks- while this doesn't mean you see the orthodontist/dentist every 2 weeks, you will have new pressure on your teeth that often. Most patients experience some tooth discomfort for a day or two with each new aligner

The final word: Depending on your malocclusion, Invisalign can be an excellent method of straightening your teeth and providing you with a perfect bite. Keep in mind that Invisalign is an ever-evolving technique and requires the orthodontist/dentist to have a firm grasp of tooth movement using a removable appliance. Currently, the majority of certified Invisalign providers do not have a firm understanding of moving teeth with Invisalign, as there is a big difference between how teeth should and can be moved in terms of order and direction. Invisalign isn't applicable for all tooth movements, but an experienced provider will be able to address a wider variety of situations.

If you would like to schedule your complimentary consultation for braces or Invisalign, please call 905-477-7750.

Summer is here. Your Markham Orthodontist Reminds you to Protect Yourself in the Sun!

It looks like summer has finally made it. School has ended, exams are done, and the hot weather is here. Our phone is going off the hook with patients scheduling consultations for braces and Invisalign. If you wish to schedule your complimentary evaluation, please call us at 905-477-7750.

Your Unionville braces and Richmond Hill Invisalign team at Markham Centre Orthodontics wish all of our patients and family a wonderful and safe summer. Stay cool and protect yourself from the sun. Below is information from Health Canada regarding fun in the sun.

Exposure to UV radiation, primarily UVB, can cause sunburns and may eventually result in skin cancer. It is important to note that while sunscreens can help reduce sunburn, they are not as effective against the other harmful effects of UV rays, such as premature aging of the skin and depression of the immune system.

All sunscreens have a sun protection factor (SPF) on their labels. The SPF represents the length of time that sunscreen-protected skin can be exposed to UVB rays before a minimal redness (erythema) appears, compared to the length of time it takes on unprotected skin. In other words, it indicates how much longer you can be exposed to the sun before getting a sunburn.


The amount of time it takes for unprotected skin to burn depends on skin type. In general, fair skin burns more quickly than darker skin. If you have the type of skin that would burn after 20 minutes in the sun without protection, then the proper application of sunscreen with SPF 15 would allow you to spend up to 300 minutes (15 times longer) in the sun without getting a sunburn. However, this does not mean that your skin is protected from all UV effects. Damage to your skin, other than sunburning, may have already started.

The SPF varies depending on the nature of the sunblocking ingredients in the product. Since the SPF refers only to protection against UVB, it is important to choose a "broad spectrum" sunscreen that also protects you from UVA radiation.

How Sunscreens Protect Your Health

There are many different brands of sunscreen available. They are classified according to their active ingredients, as some products contain chemical filters, some contain physical filters, and some contain both.

* Chemical filters absorb some of the UV radiation and convert it into heat. There are more chemical filters that absorb UVB rays than absorb UVA rays.
* Physical filters are small particles (usually zinc oxide or titanium dioxide) that scatter and reflect both UVB and UVA rays.

Minimizing Your Risk

Protect your health by using a broad spectrum sunscreen with an SPF of at least 15. Look for claims on the label indicating that the product has staying power (e.g., water resistant, very water resistant, waterproof).

For best results, be sure to follow the instructions on the product label. Use the recommended amount of sunscreen and respect the waiting period between application and exposure to the sun. Reapply sunscreen 20 minutes after you go out, so that the product stabilizes on your skin and gives you maximum protection. If you are sweating heavily or swimming, reapply sunscreen frequently to get the best protection.

Here are other steps that Health Canada recommends you take to protect against UV exposure:

* If possible, avoid being in the sun between 11:00 a.m. and 4:00 p.m.
* Look for shade, stay under a tree, or use an umbrella.
* During outdoor activities, wear sunglasses to protect your eyes. When the UV index is three or higher, you should also wear protective clothing and a large-brimmed hat.
* Remember to apply sunscreen to all exposed areas of your skin.

Your Markham Braces and Richmond Hill Invisalign Orthodontist Says That Gum Disease Can Affect Your Heart

Recent research shows that there is a direct connection between gum disease (also known as periodontal disease) and heart disease. There are several theories that explain the connection between gum disease and heart disease, but the most common theory contests that gum disease is caused by teeth that are not aligned properly. Plaque causing bacteria will begin to form on and between the teeth. The bacteria can be carried into the body’s blood stream causing blood clots that restrict nutrients and oxygen from reaching the heart.

The connection between orthodontics and periodontics is so important that Dr. Tam attended the February 2009 American Association of Orthodontics and American Academy of Periodontolgy Joint Specialties Conference in Orlando. Continuing education is an extremely important part of Dr. Tam's ongoing attitude towards providing the most up-to-date treatment possible.

By brushing your teeth at least twice a day, flossing and undergoing orthodontic treatment if your teeth are not perfectly aligned, you can prevent plaque buildup that results in heart complications. Remember, your teeth are a part of your body; and just like any other part of your body, your mouth is just as susceptible to disease!

Here's a 7 minute video clip from ABC on the subject.



Call (905)477-7750 for your complimentary orthodontic consultation with braces and Invisalign in Markham, Toronto, Unionville, Richmond Hill, Scarborough, Pickering, Ajax, Stouffville, York Region, Downtown Markham, North York, Thornhill, and the rest of the Greater Toronto Area. Let Markham Centre Orthodontics show you the Secret Behind Markham and Greater Toronto's Best Smiles!

ClearCorrect Tries to Woo Doctors Unhappy with Invisalign Proficiency Requirements

There has been a lot of talk about Invisalign's new proficiency requirements for their doctors. Your Markham Invisalign and Richmond Hill Braces orthodontist broke the story for you last week. It seems perfect timing for another company, ClearCorrect, to come out and try to take some market share. Currently, they have FDA approval, but are still waiting to get into the Canadian market.

Here is an email that was forwarded to me by a colleague:


ClearCorrect is based in Houston, Texas and according to the company, was founded by some of the biggest users of aligners. They offer two products. A two year treatment of up to 64 aligners, or a limited treatment of up to 12 aligners. The mid-course correction and refinement are included, as long as the treatment stays within the number of allotted aligners. Refinements of up to 4 sets are available for an additional cost. Their price point for doctors is about 70% that of Invisalign. Another difference to orthodontists or dentists is that one set of retainers is provided in the lab cost (may or may not make a difference to the patient cost). They are also provided with a model in case they wish to fabricate additional retainers in-office.

Although there is no literature or video published on the manufacturing process, they claim to have a similar process compared to Invisalign. All work is done in-house in Houston. They claim to cut costs by not requiring field reps in each territory. They also claim that their aligners are more clear. Online certification is available for doctors to discuss the process, and like Invisalign, does not show doctors how to move teeth. Other than that, it does not appear that there is any online continuing education. Invisalign now has over 200 hours of CE online as a part of their pathways to proficiency.

This is the second major company that has tried to compete with Invisalign. OrthoClear, started by the one of the founders of Invisalign, was bought out by Align within a very short period of time. They had promised lower prices, better service, etc for doctors unhappy with Invisalign. It caused a tremendous problem for doctors and patients who were left stranded in the middle of treatment. Invisalign took the high road and offered to continue treatment for these patients after the buyout. It is far too early in the game to see if ClearCorrect will be able to survive in this market dominated by Invisalign. From our standpoint, Markham Centre Orthodontics will not use ClearCorrect unless it is proven to be superior to Invisalign, and shows longevity in the market. Our patients deserve to be treated as over one million Invisalign patients, rather than with a company we cannot yet vouch for.

Invisalign does not seem too worried about ClearCorrect. The goal of their proficiency requirements was to prevent less experienced doctors from using their product, often incorrectly. This includes both orthodontists and GPs, resulting in claims by both doctors and patients that "Invisalign doesn't work". Many of the doctors who are upset with Invisalign are those that wish to offer it as a "bait and switch", but usually tell patients they will need alternative treatments. Invisalign seems happy to let these doctors who treat one or two patients annually, work with another company.

Remember that proper treatment planning and diagnosis is the key to successful Invisalign in Markham and braces in Unionville. To schedule your complimentary examination with your Richmond Hill orthodontist, call 905-477-7750. We look forward to the opportunity to meet you!

Markham Orthodontist Provides Details about Invisalign Proficiency

Here at Markham Centre Orthodontics, we draw Invisalign patients from all over the Greater Toronto Area, including Markham, Richmond Hill, Thornhill, Unionville, Scarborough, Pickering, Ajax, Stouffville, and more. Our patients are well-educated about Invisalign and understand that they are choosing an experienced Premier Provider Invisalign orthodontist for their treatment.

While Invisalign is a fantastic way to straighten teeth without braces, it isn't as easy as taking an impression, seeing a movie, and expecting to see a result. There are many important aspects to proper Greater Toronto Invisalign treatment, requiring knowledge of how teeth move with aligners.

The parent company of Align Technologies has recognized that there is a problem with less experienced providers, including both dentists and orthodontists. As such, they have made a move to ensure a certain level of competency and experience for Invisalign providers. Interestingly, the majority of complaints about this new program are from a large number of general dentists and a smaller number of orthodontists. On a side note, this move has been applauded by the American Association of Orthodontists.


Our Markham Invisalign patients should feel assured that we met the requirements in the first month of 2009. In fact, we have far exceeded the minimal levels and are in the top 5% of Invisalign Providers in North America. We have also been the choice of Invisalign certified Markham dentists and their family members for their own Invisalign braces. You are in good hands :).

Contact us at 905-477-7750 to schedule your complimentary initial assessment for Richmond Hill Invisalign, Thornhill Invisalign Teen, and Markham Invisalign Express with your Greater Toronto Invisalign Premier Provider Orthodontist. Find out more about Invisalign here.

Press release from Invisalign:

Align Technology Announces Invisalign® Proficiency Program to Help Doctors Build Product Experience

New product proficiency baseline requires 10 case starts and 10 CE credits per year
SANTA CLARA, Calif., June 2, 2009 -- Align Technology, Inc. (Nasdaq: ALGN) today announced that it is implementing a product proficiency program in North America to help ensure that Invisalign-trained doctors have the experience and confidence necessary to achieve high quality treatment outcomes for Invisalign patients. The Invisalign System is an evolving, skill-based procedure that requires regular usage and ongoing education to develop proficiency with the product and technique. The Invisalign proficiency initiative, along with ongoing improvements in Invisalign products, training and support, is evidence of Align’s commitment to helping Invisalign-trained doctors gain the knowledge and experience they need to be successful with Invisalign.

Effective June 1, the Invisalign product proficiency program requires every Invisalign provider in North America to start 10 Invisalign cases and complete at least 10 Invisalign-specific continuing education (CE) credits each calendar year to maintain active provider status. Doctors who do not meet the annual case start and CE requirements by the end of each calendar year, starting with December 31, 2009, will be able to continue treating any cases in-progress, but they will not be eligible to submit new Invisalign cases or to use Invisalign marketing resources. Doctors can reactivate their provider status by retaking Invisalign Clear Essentials I training and meeting the proficiency requirements during the new calendar year.

“Based on more than a million patients treated to date, we know that a doctor’s proficiency levels with Invisalign are a reflection of his or her Invisalign case experience,” said Dan Ellis, vice president North America Sales. “We are committed to helping our customers gain the product knowledge and confidence they need to achieve high quality treatment outcomes. In addition, by ensuring a baseline of experience, Align can also better support the needs of Invisalign providers by tailoring programs and services to help doctors build and maintain a working knowledge of Invisalign.”

As part of the Invisalign proficiency program, Align has created a Proficiency Pathway to ensure that doctors have the appropriate education tools and support to be successful with Invisalign. The Proficiency Pathway provides clinical educational opportunities to help doctors achieve confidence with Align Technology Inc. 881 Martin Avenue Santa Clara, CA 95050 Tel: (408) 470-1000 Fax: (408) 470-1201

Align Technology, Inc. Announces Invisalign Proficiency Program case selection and treatment planning, case submission and treatment management, as well as aspects of practice development. The pathway is divided into six milestones and under each milestone Align has identified courses or content specifically related to increasing a doctor’s knowledge and confidence based on his or her current case experience level.

Dr. Randol Womack completed Invisalign training in 1999 and has been teaching Invisalign courses since 2001. “As with any health-related service, the doctor has the obligation to become proficient in his or her proposed treatment method in order to represent a predictable resolution to the patient’s prime concern and expectation.” said Dr. Womack. “The combination of training and sufficient experience with the Invisalign System is key to ensuring the doctor has the confidence needed to provide patients with the great outcomes they expect.”

Invisalign-trained doctors now have a range of Invisalign products that provide treatment solutions for most day-to-day treatment needs. In 2008, Align introduced three new product offerings with new features, tools and delivery options to meet specific clinical demands while providing a family of end-to-end solutions for doctors. With the launch of these new products, the Invisalign product family includes: Invisalign Express for simple/limited treatment cases, Invisalign Full or Invisalign Assist for comprehensive or complex cases, Invisalign Teen for younger patients, and Vivera Retainers for post-treatment retention.