Tell the ITC what you think

Notice of Commission Determination to Review the Final Initial Determination of the Administrative Law Judge; Schedule for Filing Written Submissions on Review

Good news!

The ITC has unanimously decided to review ALJ Rogers' initial determination. The commission is asking Align some tough questions, and we're optimistic that they'll end up deciding in our favor (like they did last time).

In the meantime, the ITC wants to hear from "interested parties" about whether granting Align's request to block us from using imported data would serve the public interest:

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

This is a unique opportunity to make your voice heard. Send your thoughts to itc@clearcorrect.com by August 6, 2013, and we'll pass them along to the ITC.

Thanks for your support.

Sincerely,

Jarrett Pumphrey, CEO

What happened this week at the ITC?

The rumor mill has been spinning overtime, so let's make a few things clear:

  • Align has not won any of their suits against us.
  • We are still making aligners.
  • Nothing has changed.

First, a quick recap. As you probably know, our good buddies at Align have a long history of suing their competitors. This doesn't usually work out that well for them—Align has had patent claims invalidated and they've paid out tens of millions of dollars in settlements.

But old habits die hard, and they've stuck to this strategy against us. In March 2011, Align sued us in California and Texas, and in March 2012, they filed two complaints with the ITC. These cases take a long time to play out: nothing significant has happened in the California case, and the Texas case is on hold. The first ITC complaint was decided in our favor this January.

This week, Administrative Law Judge (ALJ) Rogers issued his initial determination for the second ITC complaint. His opinion was that ClearCorrect did not violate Align's product claims, but Align's method claims were violated. Naturally, we disagree with that opinion. Regardless, here's what you need to know:

  1. This is not the final ruling on the case. The ALJ's initial determination will be reviewed by the ITC before they make their final decision, scheduled for September 2013. Then that decision is likely to be appealed in the U.S. Court of Appeals for the Federal Circuit. The ultimate conclusion is probably still years away.
  2. In the previous complaint, the ITC reversed this same judge's initial determination and ruled in our favor.
  3. We don't have to do anything differently right now. There's no effect on our day-to-day operations until the ITC makes their final decision.
  4. This initial determination has been incorrectly reported as "a ruling to block U.S. imports of a competing product by ClearCorrect." We make our aligners right here in Houston, Texas, so it's impossible for the ITC to block us from "importing" them. The only "imports" at stake in this case are digital files transmitted by diagnostic technicians in Pakistan. (We've argued that data transmissions shouldn't even be considered imports.)
  5. Align's legal VP recently claimed to investors that if the ITC ruling went their way, "ClearCorrect will be excluded from the domestic market." That's simply not true. Even if the ITC rules completely in Align's favor, we can continue manufacturing and selling aligners in the U.S. The only thing the ruling will determine is how and where we can stage the treatment plans.

In short, don't panic. We're sticking around. We've just invested in scaling up our production capacity by 30%, and we've got a really cool announcement to share with you tomorrow. Until next time…

Update: Align put out a second press release shortly after this was posted, but nothing has changed. The "cease and desist orders" they refer to are just the ALJ's recommendations from his initial determination. As explained above, the ITC is not expected to make a decision until September. If the ITC does issue cease & desist orders, they will apply only to imported data—our ability to design, manufacture, and sell aligners in the U.S. is not at risk.

ITC ruling will not affect ClearCorrect's products or service

ClearCorrect's US operation remains unrestricted; Align Technology's litigious campaign remains unsuccessful

ClearCorrect, LLC announced today that it received notice of an initial determination in the patent infringement complaint filed by Align Technology, Inc. with the US International Trade Commission (ITC).

Align's complaint, filed in March 2012, alleged that ClearCorrect and ClearCorrect Pakistan (Private) Ltd. ("ClearCorrect Pakistan") infringed claims of seven Align patents and sought to have ClearCorrect excluded from the US market. Administrative Law Judge (ALJ) Rogers' initial determination presents his opinion that ClearCorrect did not infringe any of Align's product claims, but that Align's method claims (those claims concerning the way a certain process is performed) were infringed. The ALJ's opinion will be one of the factors that the ITC will take under consideration when making its final ruling, expected in September 2013. In Align's previous ITC complaint against ClearCorrect, the ITC decided to reverse ALJ Rogers' initial determination and found no wrongdoing by ClearCorrect.

"We view the preliminary ruling on the product claims as a big win and look forward to the Commission's review of the method claims," said Jarrett Pumphrey, ClearCorrect CEO. Indeed, the ITC's own staff attorneys have interpreted US patent law to mean that ClearCorrect does not infringe most of Align's method claims and ClearCorrect will present that interpretation when it asks the Commissioners to find no infringement of any of Align's patents. "We're hopeful the Commission will view the law as both we and their staff attorneys do," continued Pumphrey, "but even if the Commission upholds the Judge's recommendation in full, it won't have any material impact on our company or our ability to make aligners. That's what counts." In fact, ClearCorrect recently invested in increasing the production capacity of its US-based manufacturing facility by another 30%. "Business has been good lately," Pumphrey added, "and we're happy we can continue servicing our doctors who have all been so supportive."

The notice of the initial determination did not include the recommended remedy. However, the worst-case scenario for ClearCorrect would simply be the exclusion of computer data prepared by ClearCorrect Pakistan. Because ClearCorrect manufactures its aligners in the US, there are no aligner imports for the ITC to block. Though only last month Align boasted "ClearCorrect [would] be excluded from the domestic market," the reality is ClearCorrect is still allowed to service its customers in the US and will continue to do so. The preliminary decision thus falls squarely in line with Align's other failed efforts to prevent competition through litigation. Align's highly-publicized case against Ormco Corporation resulted in the invalidation of Align's patent claims and a settlement that paid Ormco tens of millions of dollars, including 10% of Align's stock. Align's first ITC case against ClearCorrect resulted in complete victory for ClearCorrect. And now Align's second ITC case has failed to prevent ClearCorrect from competing in the US market.

"ClearCorrect fully intends to press the investigation further and ask the Commission to find that Align's patents are invalid because of the vast amount of prior art," said Mike Myers, ClearCorrect's legal counsel. "ClearCorrect has always held that orthodontists taught Align about clear aligners, not the other way around, and, if necessary, ClearCorrect will pursue its arguments all the way up to the Federal Circuit Court of Appeals, the same court that held Align's patents invalid in the Ormco case."

PDF
Notice Regarding Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond

Tech tip: Aligner material Q&A

This week, we've answered some frequently-asked questions about our aligner material. Got more questions? Feel free to ask them in the comments section below.

For further reading and complete information about our aligner material and safety information, view and download our material information on ClearComm. 

What are ClearCorrect aligners made out of?

Our aligners are made from Zendura, a custom formulation of medical-grade polyurethane which has been thoroughly tested for biocompatability. This advanced plastic was created exclusively for ClearCorrect by Bay Materials.

Are ClearCorrect aligners BPA free?

Yes! Our aligners are FDA approved and free of bisphenol-A ("BPA") and phthalates. 

Are ClearCorrect aligners safe for patients who are pregnant or nursing?

As stated in our material information, our aligners are free from harmful chemicals and do not pose a significant risk to the patient's health. However, as the doctor, we leave the treatment decisions up to you. We are committed to providing all the information available on our aligner plastic so that you and your patient can make an informed decision together.

Can my patient drink hot beverages like coffee or tea while wearing aligners?

We don't recommend it. Hot liquids can distort the material. Coffee and tea are also likely to stain the aligners, and sugar can get trapped between the teeth and the aligners. It's best to remove the aligners before eating or drinking anything other than water.

Is the Zendura used to make the aligners the same as the Zendura sold in the online store?

Yes! The same Zendura plastic used to make your patients' aligners is available on our online store at a providers-only price of $60 for 20 sheets. This way, you won't have to compromise quality for the convenience of making your own aligners in-house.

What machines can I use to make my own Zendura aligner?

Bay Materials recommends the use of a pressure-forming machine (such as a Biostar, MiniStar, or Drufomat) when thermoforming Zendura plastic. However, you may achieve great results using a vacuum-forming machine by following these specific instructions.

Bonus question:

What kind of material are your models made from?

The models included with each aligner shipment are made from VeroDent, a biocompatible photopolymer engineered by Objet specifically for dental applications. You may view a video of our 3D printers in action here (video produced by Objet).

New treatment options for 2013

Note to consumers: Our lab fees are confidential. Which is a shame, because they’re really worth bragging about. If you’re a dentist or orthodontist, give us a call at (888) 331-3323 to get the full scoop. If you’re already a provider, details are available on our wiki.

We’re excited to introduce our all-new treatment options, available starting January 1, 2013.

We tested countless variations before finalizing these options. Based on the feedback we’ve received from doctors, we think these new options will provide the greatest combination of affordability, flexibility, and predictability ever available for clear aligners.

Let’s get started, shall we?

Limited 6 — $███

We believe this will be the most affordable clear aligner treatment option available in the industry.

The Limited 6 is ideal for simple anterior adjustments. It includes up to 6 steps of clear aligners (single or dual arch). That’s more aligners than the competition, offered at a lower price. This price is not a limited-time promotion—it’s our everyday lab fee.

Like every ClearCorrect case, this comes with a treatment setup, and (unlike the other guys) Phase Zero and retainers are included at no extra cost. (We could have called this Limited 8, but we didn't want to rub it in.)

Limited 12 — $███

Cases you currently submit as Limited will be treated as a Limited 12, starting January 1.

It’s very similar to what you’re familiar with—you still get up to 12 steps of clear aligners, plus a setup, Phase Zero, and retainers. There's still no fee for revisions, so long as you stay under 12 total aligners. Up to 2 free replacement aligners are now included, and they won't count against the 12 steps allowed for your case.

Unlimited — $███

This is a biggie. If Limited 6 is the most affordable clear aligner option in the industry, this is the most flexible and predictable.

Starting January 1, any cases you currently submit as Full will be treated with the new Unlimited option. It's pretty simple to explain: you get as many aligners as you need, until the case is closed. That includes unlimited revisions for up to 3 years and replacements for any step at no extra cost. Seriously.

While you take a minute to let that soak in, I’ll just mention that the Unlimited lab fee can actually sink as low as $███ with our new volume discount program. (More on that another time.)

We'll also be offering case evaluations and standalone setups to lower the barrier to entry even further. And you can upgrade any case (including legacy Limited and Full cases) to a more comprehensive treatment option just by paying the difference in lab fees. We've added answers to most of your questions about these changes on the wiki, and we'll introduce updated terms & conditions soon with full details.

It’s the same great ClearCorrect product you're used to, now even more flexible and doctor-friendly.

What’s the catch?

As the sharper-eyed among you may have noticed, the Limited 12 and Unlimited lab fees are slightly higher than the current Limited and Full options. We haven’t raised our prices since we started 6 years ago, and we don't plan to do it again any time soon.

Here's why we're making this change now:

  1. We heard your feedback: you love the flexibility of phase-based delivery, but you don’t like keeping track of unused phases, or paying for extra ones. We've eliminated that hassle by creating the new Unlimited option. Increasing the lab fee slightly makes that feasible.
  2. The increases are partially offset by the introduction of Limited 6—our most affordable treatment option ever.
  3. This keeps us in line with inflation, and will allow us to continue to expand and improve our product.

If you want to submit cases before this price increase goes into effect, we totally understand. Any cases submitted by December 31, 2012 will be handled just like they are today, and charged at the current rates. Next year, you’ll have the option to upgrade those cases to the new treatment options at any time just by paying the difference in the lab fee.

I’m sure you want to know more. First, check out the wiki. If you still have questions, post them in the comments, and we'll include our responses in the next tech tip.

Until next time!

Open & Transparent: The Game

The third core value game was all about communication—thoughtful, quick communication.

The game goes like this: you draw a card and run back to your team. You then have to get your teammates to guess the word or phrase at the top of your card, without using any part of that word or any of the words listed below. Maybe you've played a similar game: Taboo!

We thought it was a great game to help sharpen our minds and flex a little creative muscle in our speech.

Check out the impeccable technique of our 8 teams in action. Apparently, leaning forward is key.

Execution of authentication request returned unexpected result: 404

Open & Transparent totem awarded to Paula Clark

Our first three core values are all about how you are when you interface with others. Service obviously depends on interaction with others. Passion is something you wear on your sleeve, a trait that, if you have it, should be evident to others when they speak with you.

But the first two values are cheapened if the third value isn't there. Being open & transparent is so important in doing business with others, especially these days, when the public distrusts larger companies more and more.

Paula Clark has done an exemplary job in being open and transparent with everyone she does business with. She's our director of disbursements, and her fastidiousness and honesty have set a standard for us here at ClearCorrect to follow.

Some of Paula's coworkers and friends would seem to agree:

She has a great relationship with everyone she works with. She is very helpful to people who are new or are learning the purchasing system.

She has developed great relationships with our vendors.

Paula is open to new ideas and new ways of doing things and with our company constantly growing and changing, this is an invaluable ability.

In working with money you are constantly asked for information. Paula keeps her area open and transparent to executives who need financial information.

She knows the sound of angry typing and always tells me not to hit “send” until I get back from lunch Smile

She is one of our hardest working employees and she definitely deserves this Core Value Totem.

Thanks for showing us how it's done, Paula.

Core value #3: Be open & transparent

Trust depends on openness, respect and humanity.*

—Daniel H. Pink, bestselling author

*Excerpt from “My challenge to you: only speak like a human at work

We’re lucky. We get to be something many companies don’t—we get to be real people.

Real people have names and faces. They have friends and families, real lives full of real life. They matter. They have something worth working for.

Real people aren’t perfect. They have flaws. They make mistakes and learn from them. They improve. They have something worth striving for.

Real people have opinions and values, something to speak up about. They agree with some and disagree with others. They have something worth standing for.

And real people have hopes and dreams. They have faith. They have passion. They have a certainty anything is possible. They have something worth fighting for.

There’s a lot of worth in being real, down-to-earth, shamelessly genuine people. We can count ourselves among them as long as we're open and transparent. 

So let's show the world who we really are. People will trust and respect us more when they see we’re real people—no different than them.