Lifenet Health v. Lifecell Corp.

LIFENET HEALTH, Plaintiff, v. LIFECELL CORPORATION, Defendant.

Civil Action No. 2:13cv486

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA Norfolk Division

October 27, 2014

**PubIic Version**

OPINION AND ORDER

This matter came before the Court on Defendant's Motion for Summary Judgment, Doc. 137, and Plaintiff's Motion for Partial Summary Judgment, Doc. 182. A hearing was held on October 22, 2014. Ruling from the bench, the Court DENIED the Motions. It now issues this Opinion and Order explaining its reasoning.

1. BACKGROUND AND PROCEDURAL HISTORY

A. Procedural History

On September 6, 2013, Plaintiff LifeNet Health ("Plaintiff or "LifeNet") filed a one-count Complaint, alleging that Defendant LifeCell Corporation ("Defendant" or "LifeCell") has infringed U.S. Patent No. 6,569,200 ("the '200 patent"). Doc. 1. Essentially, Plaintiff is alleging that two of Defendant's products, AlloDerm RTM Ready to Use ("AlloDerm RTU") and Strattice Reconstructive Tissue Matrix ("Strattice"), infringe certain claims in the '200 patent.¹ Id. ¶¶ 24-30. Defendant filed its Answer on November 22, 2013, denying it has infringed the '200 Patent, and additionally asserted the affirmative defenses of non-infringement, invalidity, laches, failureto mark, limitations on damages, prosecution history estoppel, patent exhaustion/implied license, and "other affirmative defenses." Doc. 12.

On July 10, 2014, the Court held a Markman hearing for the purpose of construing eight (8) disputed claim terms. Doc. 116. On July 16, the Court entered its Opinion and Order explaining its claim construction. Doc. 122.

On August 7, 2014, the Court held a telephonic hearing to address cross Motions to Compel, Docs. 46 & 74, filed by the parties. Doc. 127. In an Opinion and Order entered August 19, the Court granted the Motions to Compel in part. Doc. 130.

Defendant's Motion for Summary Judgment ("Defendant's Motion") was filed on August 27, 2014. Doc. 137. Plaintiff responded in opposition on September 11, 2014. Doc. 149. Defendant's submitted its reply brief on September 19. Doc. 195.

Plaintiff's filed its cross Motion for Partial Summary Judgment on September 16, 2014. Doc. 185. Defendant responded in opposition on October 2,2014. Doc. 210. Plaintiff filed its reply brief on October 9, 2014.² Doc. 255.

A two-week jury trial in this case is scheduled to commence on November 3, 2014.

B. Overview of Patcnt-in-Suit

The '200 patent was issued on May 27, 2003 and is titled "Plasticized Soft Tissue Grafts, and Methods of Making and Using Same." The '200 patent generally describes and claims "a plasticized dehydrated bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle and does not necessitate rehydrationprior to clinical implantation." '200 patent at 1:8-13. Essentially, the patent relates to improving the preservation method of soft tissue grafts, resulting in a lesser chance of the graft failing. Doc. 62 at 3-4. According to Plaintiff, this is done "by providing plasticized soft tissue products that are similar in physical, chemical, and biological properties as compared to normal tissue (fresh soft tissues) yet lack the inherent disadvantages ... of fresh-frozen, dehydrated, and freeze-dried soft tissue products." Doc. 65 at 3.

The '200 patent contains fifteen (15) claims, five (5) of which are independent (Claims 1-3, 7, and 15). Plaintiff is asserting claims 1-4, 7-8, and 10. Doc. 65 at 4. These claims are reproduced below.

• Claim 1: A plasticized soft tissue graft suitable for transplantation into a human, comprising:

a cleaned soft tissue graft having an internal matrix; and

one or more plasticizers contained in said internal matrix;

said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.

• Claim 2: A plasticized soft tissue graft, comprising:

a cleaned, soft tissue graft; and

one or more plasticizers, wherein said cleaned soft tissue graft is impregnated with one or more plasticizers, and said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.

• Claim 3: A plasticized soft tissue graft, comprising:

a cleaned, soft tissue graft comprising one or more plasticizers, and said one or more plasticizers are not removed from an internal matrix of said plasticized soft tissue graft prior to transplantation into a human.

• Claim 4: The soft tissue graft of any one of claims 1, 2, 3, wherein said soft tissue graft is suitable for direct transplant into a human without rehydration.

• Claim 7: A method for producing a plasticized soft tissue graft suitable for transplantation into a human, comprising;

impregnating a cleaned, soft tissue graft with one or more plasticizers to produce a plasticized soft tissue graft, and said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.

• Claim 8: The method of claim 7, said step of impregnating, comprising:

incubating said cleaned, soft tissue graft with a plasticizer composition comprising one or more plasticizers and one or more biocompatible solvents.

• Claim 10: The method of claim 8, wherein incubating comprises soaking said cleaned, soft tissue graft in said plasticizer composition.

The Court construed eight (8) disputed terms in the above claims as follows:

Disputed Term

The Court's Construction

"plasticized soft tissue graft"

a load-bearing and/or non-load-bearing soft

tissue product, including skin, pericardium,

dura mater, fascia lata, and a variety of

ligaments and tendons composed of an internal

matrix where free and loosely bound waters of

hydration in the tissue have been replaced with

one or more plasticizers without altering the

orientation of the collagen fibers, such that the

mechanical properties, including the material,

physical and use properties, of the tissue

product are similar to those of normal hydrated

tissue

"suitable for transplantation into a human"

No further construction needed

"cleaned"

a process during which cellular elements and

small molecular weight solutes are removed

"plasticizer"

biocompatible compounds which are soluble in

water and can easily displace/replace water at

the molecular level.

"said one or more plasticizers are not removed

from [an/said] internal matrix of said plasticized

soft tissue graft prior to transplantation into a

human"

No further construction needed

"impregnating" / "impregnated"

filling or filled

"without rehydration"

without hydrating a plasticized soft tissue graft

prior to implantation into a patient

"incubating"

soaking or otherwise exposing

Doc. 122 at 14. The Court also adopted the parties agreed constructions for the following three (3) terms:

1. internal matrix: the intercellular substance of such soft tissue including for example ligaments and tendons, including collagen and elastin fibers and base matrix substances

2. plasticizer composition: composition which includes one or more plasticizers and one or more biocompatible solvents

3. biocompatible solvents: any solvent material which does not provoke an adverse response in the patient

Id. at 7.

2. UNDISPUTED FACTS

A. Infringemcnt/Non-infringement

Plaintiff has accused Defendant's Strattice and AlloDerm RTU products of infringing the '200 patent. Doc. 140-1 at 3.³ Strattice and AlloDerm RTU are dermal tissue grafts preserved using Id. Cells have been removed from the accused products to make them acellular or de-cellularized. Id. at 14.

Defendant has admitted that the following claim limitations can be found in AlloDerm RTU and Strattice:

a. In claim 1: "a soft tissue graft having an internal matrix" and "one or more plasticizers contained in said internal matrix"

b. In claim 2: "a cleaned, soft tissue graft" and

c. In claim 3: "a cleaned, soft tissue graft comprising one or more plasticizers."

Doc. 190-1 at 6. The accused grafts areId. at 8, 17-18. Plasticizers are contained within the internal matrix of the accused products. Id. at 9; Doc. 214 at 24. No plasticizers are removed from the internal matrix prior to the manufacture and sale of the products. Doc. 190-1 at Prior to packaging, Id.

The Instructions for Use ("IFU") for the accused products instruct the user to "[s]oak the device for a minimum of 2 minutes using a sterile basin and room temperature saline or room temperature lactated Ringer's solution to cover the mesh." Doc. 140-1 at 3-4: see also Doc. 152-1 at 3-4. Defendant asserts that no evidence exists that surgeons have implanted the accused grafts without following the IFU. Doc. 140-1 at 4; Doc. 152-1 at 4. Defendant has conducted a study showing that a two minute rinse of Alloderm RTU removes from the grafts; while Plaintiff does not dispute that such testing occured, Plaintiff argues that the testing is incomplete, does not show if the plasticizer comes from the internal matrix, and is not a material fact. Doc. 140-1 at 4; Doc. 152-1 at 5-6.

Two other accused products are at issue, Conexa and Doc. 140-1 at 4-5. Conexa is a version of Strattice distributed by a third-party, and for the purposes of these Motions, there are no differences between Conexa and Strattice. Id. at 5. The parties dispute whether was ever "made, used, offered for sale, or sold" by Defendant. Id.

B. Anticipation

On November 2, 1982, the United States Patent and Trade Office issued Patent No. 4,357,274 ("Werner") and Werner is prior art to the '200 patent. Doc. 140-1 at 5. Werner teaches a dura mater graft, which this Court construed as an example of a soft tissue graft in itsMarkman Order.⁴ Id. at 5. Werner teaches that the dura mater graft is suitable for transplantation into a human; that the dura mater graft has an internal matrix; that the soft...