1989

Response To Nobelpharma Letter: Postsettlement Disclaimer #1

OPEN LETTER TO THE DENTAL PROFESSION

On January 4, 1989, Core-Vent (Core-Vent Corporation) and Nobelpharma (Nobelpharma AB, a Swedish Company and Nobelpharma USA) entered into a settlement agreement resolving their legal disputes. A "Joint Announcement of Settlement" statement was agreed upon by both parties to be used to inform the profession of the "amicable end to the controversy between them." On January 15, 1989, Nobelpharma conducted a wide mailing of this document and also included in the mailing a letter which misstates critical facts of the settlement and certain scientific issues related to the litigation. Core-Vent Corporation must now respond to Nobelpharma’s misleading letter to mitigate the damage its misinformation may cause.

No amount of explanation or rationalization on Nobelpharma’s part can alter the fact that, as a result of the settlement agreement, Core-Vent Corporation is now licensed under all Brånemark and Nobelpharma patents and patent applications worldwide that cover Core-Vent Corporation’s implants, including, but not limited to, the single U.S. Patent No. 4,330,891 that Nobelpharma referred to in its January 15th letter.

History of Litigation

In 1986, Nobelpharma, a subsidiary of Nobel Industries, a multi-billion dollar defence contractor, sued Core-Vent for alleged patent infringement and alleged false advertising, unfair competition and alleged attempts to monopolize the implant market. After three years of expensive maneuvering by the lawyers, the case settled the day the trial was to begin.

Objective of the Litigation

Nobelpharma’s January 15th letter states:

We believe that our objectives in bringing suit against Core-Vent have been achieved. Core-Vent has agreed to the validity of our patent and no longer publishes certain advertising claims which we complained about.

Patents

Core-Vent’s agreement to the validity of one of the Brånemark patents Nobelpharma is licensed under was not Nobelpharma’s main objective in bringing suit. If it had been, the litigation would have been settled long ago. Past and present executives of Nobelpharma stated that its objective was to eliminate Core-Vent as an effective competitor in the implant market. Nobelpharma’s failure to achieve this objective has strengthened Core-Vent’s marketing position by sharing with Core-Vent worldwide patent rights under many of Dr. Brånemark’s patents and patent applications.

Advertising

The advertising Nobelpharma complained about was factual, appeared on or before 1986 and is no longer published because it became outdated for marketing purposes. Core-Vent’s counter suit contended that Nobelpharma’s advertisements were exaggerated and therefore misleading. Since the litigation started, both companies have made changes in their advertising, but not as a result of the settlement agreement.

The Profession is the Real Winner

The real winner is you, the dental professional, who now has a choice of two companies selling commercially pure titanium implants with a micro-pitted surface which, as Professor Brånemark states in his patent, "provides the bio-optimal result." The patented micro-pitted surface and the reduced risk perception some professionals associate with Brånemark’s research that led to the discovery of the patented micro-structure, are now available from Core-Vent Corporation. The Swede-Vent Implant from Core-Vent, because of its design and dimensions, can be inserted using Nobelpharma’s surgical instruments of Core-Vent’s internally irrigated drills. The Screw-Vent Implant from Core-Vent matches the thread design and dimensions of the Brånemark fixture, but is provided with a neck that is no wider than the threads, eliminating the need for countersinking the crest of the bone. It is also designed to be self-tapping with threads all the way to the apex. Both Swede-Vent and Screw-Vent Implants are machined and then acid etched to provide a metallurgically clean, micro-pitted surface. Core-Vent Corporation manufactures its implants and prosthetic abutments to the highest standards of quality and precision in the industry. Because of the settlement, Core-Vent Corporation has been able to keep the same low prices for its implants, instruments and prosthetic abutments in 1989 as it had in 1988. Core-Vent provides its products to the profession at up to a 50% cost savings per implant (single unit price) and a 61%-71% cost savings per abutment compared to Nobelpharma’s prices –– WHY OVERPAY?

Significance of Brånemark’s Patented Micro-Pitted Surface

Nobelpharma’s January 15th letter wrongly states that "the patented invention involves only a particular type of micro-pitted surface on certain implants." That statement relates only to one part of one of the many patents and patent applications, worldwide, now licensed to Core-Vent Corporation.

Fact:

The "type of micro-pitted surface" covered by the "patented invention" was a result of Brånemark’s clinical studies. The Brånemark patent states that:

An analysis of jaw implants in homo has unexpectedly shown that the operation results obtained are noticeably improved if the size of the micro-pitting approaches the order of magnitude of the cell diameter in the surrounding tissue or of a few multiples thereof. The normal cell size applicable is the order of 1000 nm.

The Brånemark patent further states that:

The bio-optimal result is achieved, however, if the pit diameter is selected in the range of 10 to 300 nm.

An independent court expert was appointed to examine Nobelpharma and Core-Vent Corporation implants using computer-enhanced SEM analysis. He employed a sophisticated computer program to count the pits and reported his findings. His report confirmed that the surface treatment each company was applying to their implants resulted in substantially the same number of micro-pits in the range of 10 nm to 300 nm.

Nobelpharma’s January 15, 1989, letter states:

P.I. Brånemark’s years of experimentation and development led to adoption of a standardized implant design and material.

Fact:

"P.I. Brånemark’s years of experimentation and development" also led to filing in 1979 of his application for U.S. Patent No. 4,330,891, the claims of which cover a micro-pitted titanium implant with a threaded surface and an apical vent. The Swede-Vent Implant from Core-Vent Corporation matches the "standardized" Brånemark implant in design, material and dimensions and now provides the patented micro-pitted surface that Brånemark’s Patent No. 4,330,891 states will give "inextricable anchoring in the living bone tissue."

Nobelpharma’s January 15th letter states:

Core-Vent surfaces are acid etched in contrast to Brånemark fixtures which have a machined surface approved by Professor Brånemark.

Fact:

Core-Vent Corporation’s implants are first machined and then carefully acid etched to remove contaminants. Core-Vent started to acid etch its implants in 1986 because it is the best, if not the only way, to remove inorganic contamination from machined surfaces. Core-Vent’s proprietary formula of acid concentrations, the specific time the implant is exposed to the acid and the type of neutralizing solutions used to wash the etched implants produce the super-clean, micro pitted surface that, according to Brånemark’s patent, produces "the bio-optimal result."

Nobelpharma’s January 15th letter refers to "the formula for the Brånemark System":

Among the patents both Nobelpharma and Core-Vent are now licensed under is U.S. Patent No. 4,330,891, issued to Brånemark et al. in 1982, which spells out the formula for the Brånemark Implant:

1. Material: Bio-compatible

Special materials such as titanium, titanium alloys, ceramic material or metal covered with ceramic material have been found to give acceptable biological integration.

2. Design: Screw design with vents

Over many years of experimental work, firm joints have been achieved with materials prepared in various manners, the surfaces of the connecting device being shaped with increased surface contact by means of corrugations and threading thereof.

It has also been found advantageous to provide the implant with large through openings for bone tissue to grow through.

3. Surface: Clean and micro-pitted

Accordingly, the present invention provides an element intended for implantation in the body tissue consisting of a biologically flawless material with a porous, i.e., micro-pitted surface intended to face the tissue.

4. Production: Machining most economic; Machining followed by acid etching also covered by patent

Of course, the surface may be produced in some other manner, such as by sintering or metal vaporization in inert gas. However, the most economic method appears to be preparation with a cutting tool.

5. Surgical Procedures: #9; Low speed bone preparation

Experience has shown that careful threading of drilling holes in the bone tissue and of the corresponding implant using cutting tools of titanium working at low speed gives the best seal.

Nobelpharma’s January 15th letter states:

...the settlement protects our proprietary interests in implant technologies.

Fact:

Nobelpharma’s lawsuit did not claim that Core-Vent misappropriated any trade secrets or other "proprietary interests in implant technologies," so there were no "proprietary interests" the settlement protected. Professor Brånemark’s patents, published articles and books enable one to make the implant he patented.

Conclusion:

As a result of the lawsuit and counter suit, Nobelpharma and Professor Brånemark have granted Core-Vent Corporation a license under all presently issued patents and pending patent applications worldwide owned by Nobelpharma or Brånemark that cover Core-Vent Corporation’s implants. This includes U.S. patent No. 4,330,891, the same patent listed in Nobelpharma’s product catalog and journal advertisements.

Nobelpharma’s January 15th letter states that the decision to license Core-Vent "does not in anyway represent an endorsement of Core-Vent’s products." Core-Vent Corporation neither wants nor needs Nobelpharma’s endorsement. The only endorsement Core-Vent believes is important is from the world dental community, and we will now be able to dedicate our resources to further achieve this objective. Core-Vent Corporation is proud to provide the profession with a wide variety of implants and prosthetic abutments, manufactured to the highest standards in the industry at prices that are affordable to both dentist and patient alike.