DCT
1:11-cv-12064
Smith & Nephew Inc v. Hologic Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Smith & Nephew, Inc. (Delaware)
- Defendant: Hologic, Inc. (Delaware)
- Plaintiff’s Counsel: Nixon Peabody LLP
- Case Identification: 1:11-cv-12064, D. Mass., 11/22/2011
- Venue Allegations: Venue is alleged to be proper under 28 U.S.C. §§ 1391 and 1400. The complaint notes that both Plaintiff and Defendant maintain a place of business in Massachusetts.
- Core Dispute: Plaintiff alleges that Defendant’s "MyoSure®" Tissue Removal System infringes a patent related to a surgical endoscopic cutting device and its method of use for intrauterine tissue removal.
- Technical Context: The technology relates to hysteroscopic surgical devices used to remove tissue, such as polyps and fibroids, from a patient's uterus in a minimally invasive procedure.
- Key Procedural History: The complaint was filed on the same day the patent-in-suit issued. The day prior to issuance, Plaintiff allegedly sent a letter to Defendant providing notice of the imminent patent and asserting that continued sales of the accused product would constitute infringement. A subsequent inter partes reexamination of the patent-in-suit, requested in 2012, resulted in the cancellation of two claims (including asserted claim 4) and the confirmation of the remaining claims. The patent was also the subject of litigation that reached the U.S. Court of Appeals for the Federal Circuit.
Case Timeline
| Date | Event |
|---|---|
| 1997-09-04 | ’359 Patent Priority Date |
| 2011-11-21 | Plaintiff sends notice letter to Defendant |
| 2011-11-22 | U.S. Patent No. 8,061,359 Issues |
| 2011-11-22 | Complaint Filed |
| 2019-03-06 | ’359 Patent Reexamination Certificate Issued |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,061,359 - Surgical Endoscopic Cutting Device And Method For Its Use
- Issued: November 22, 2011
The Invention Explained
- Problem Addressed: The patent describes challenges with prior art methods for removing tissue from the uterus, which were often time-consuming and required the use of non-conducting fluids that could cause dangerous electrolyte imbalances in the patient if absorbed. (’359 Patent, col. 1:35-43). A further problem was the difficulty in accurately controlling fluid pressure within the uterine cavity during such procedures. (’359 Patent, col. 2:12-16).
- The Patented Solution: The invention is a method and device for endoscopic surgery that uses an endoscope with separate, discrete channels for viewing and for a cutting instrument. (’359 Patent, col. 6:21-27). The system is designed to use a physiological fluid (e.g., saline) to distend the uterus; the same fluid is then used to carry away tissue that has been cut by a motor-driven tool. (’359 Patent, col. 4:41-44). A key aspect is the fluid management system, which provides for continuous fluid flow to maintain a clear operating field and stable pressure inside the cavity. (’359 Patent, col. 4:21-33).
- Technical Importance: The claimed method allows surgeons to use a safer physiological fluid, reducing risks to the patient, while simultaneously providing a more efficient, single-instrument approach to cutting and removing tissue. (’359 Patent, col. 4:41-48).
Key Claims at a Glance
- The complaint asserts infringement of at least Claims 1, 3, and 4. (Compl. ¶12). Claim 4 was subsequently cancelled in reexamination.
- Independent Claim 1 recites a method with the following essential elements:
- inserting a distal region of an endoscope into a uterus, where the endoscope has an elongated member defining discrete first and second channels, with the first channel having a light guide permanently affixed and being sealed from the second channel.
- inserting a motor driven cutter into the second channel.
- delivering fluid into the uterus through a valve and the second channel to distend the uterus.
- energizing a motor to drive the cutter to cut tissue.
- aspirating cut tissue and fluid from the uterus through the cutter.
- The complaint reserves the right to assert other claims, including dependent claims. (Compl. ¶12).
III. The Accused Instrumentality
Product Identification
The Hologic MyoSure® Tissue Removal System ("MyoSure® System"). (Compl. ¶10).
Functionality and Market Context
The "MyoSure®" System is alleged to comprise a MyoSure® Tissue Removal Device, a MyoSure® Rod Lens Hysteroscope, and a control unit that drives the device. (Compl. ¶10). It is sold to doctors and hospitals for the purpose of removing tissue such as fibroids and polyps from a patient's uterus. (Compl. ¶10). Plaintiff alleges that it is a direct competitor with Defendant Hologic in this market, where Plaintiff sells its own "TRUCLEAR™" System. (Compl. ¶¶9-10).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’359 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| inserting a distal region of an endoscope into said uterus, the endoscope including a valve and an elongated member defining discrete first and second channels...the first channel having a light guide permanently affixed therein and being sealed from the second channel... | The "MyoSure®" System includes a hysteroscope (endoscope) which is inserted into the uterus to perform a tissue removal method. | ¶¶8, 10, 11 | col. 5:21-32 |
| inserting a motor driven cutter into the second channel such that a distal cutting region of the cutter extends distally beyond the endoscope in the uterus; | The method involves inserting the MyoSure® Tissue Removal Device (a motor-driven cutter) into the hysteroscope. | ¶¶8, 10, 11 | col. 5:33-36 |
| delivering fluid into the uterus through the valve and the second channel to distend the uterus; | The method involves delivering fluid through the hysteroscope into the uterus. | ¶¶8, 11 | col. 5:37-39 |
| energizing an electric motor to drive the cutter to cut tissue within the uterus; and | The "MyoSure®" System includes a control unit that energizes the motor to drive the cutter and cut tissue. | ¶¶8, 10, 11 | col. 5:40-41 |
| aspirating cut tissue and fluid from the uterus and the endoscope through the cutter. | The method involves removing cut tissue and fluid through the cutter. | ¶¶8, 11 | col. 5:42-44 |
- Identified Points of Contention:
- Scope Questions: A central dispute may focus on the construction of "discrete first and second channels." The infringement analysis will depend on whether the accused MyoSure® Hysteroscope has a structure that meets this limitation, as opposed to, for example, a single multipurpose channel or a different configuration.
- Technical Questions: The complaint does not provide specific evidence that the accused hysteroscope has a "light guide permanently affixed" within a first channel that is "sealed from the second channel." Factual questions may arise as to the actual physical construction of the accused device and whether it meets these specific structural requirements of the claim.
V. Key Claim Terms for Construction
The Term: "discrete first and second channels"
- Context and Importance: This term defines the fundamental architecture of the endoscope. Whether the accused MyoSure® Hysteroscope infringes will likely turn on whether its internal structure can be characterized as having two distinct and separate channels as claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the channels as being defined within an "outer tube" and that one channel is for viewing and the other is for the cutter, which could suggest a functional definition. (’359 Patent, col. 4:51-56).
- Evidence for a Narrower Interpretation: Figure 1a of the patent depicts a very specific embodiment with two fully enclosed, circular channels separated by a solid partition wall. A party could argue that "discrete" requires this type of physical separation, not just functionally separate pathways. (’359 Patent, Fig. 1a).
The Term: "sealed from the second channel"
- Context and Importance: This limitation is critical for ensuring the viewing optics remain clear of the fluid and tissue being managed in the second (working) channel. Practitioners may focus on this term because infringement depends on the factual nature of the boundary, if any, between the optical and working paths in the accused device.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim's purpose is "to prevent fluid from the valve from entering the uterus through the first channel." (’359 Patent, col. 6:29-32). This could support an interpretation where any structure that achieves this functional outcome during use is considered "sealed," even if not hermetically.
- Evidence for a Narrower Interpretation: The plain meaning of "sealed" suggests a complete physical barrier. The description of the channels as "discrete" could reinforce an interpretation requiring a permanent, fluid-tight structural separation between the two channels.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement under 35 U.S.C. § 271(b) and (c). (Compl. ¶13). Inducement is based on allegations that Hologic sells the MyoSure® System to customers with the knowledge and intent that they will use it in an infringing manner. (Compl. ¶¶11, 13). Contributory infringement is based on allegations that the system is "especially made or especially adapted" for an infringing use and has "no substantial non-infringing use." (Compl. ¶¶11, 13).
- Willful Infringement: Willfulness is alleged based on Hologic’s continued infringement after receiving notice of the patent. (Compl. ¶14). The complaint alleges that this notice was provided via a letter delivered on November 21, 2011, the day before the patent issued. (Compl. ¶12).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction and factual proof: Does the accused MyoSure® Hysteroscope’s physical structure embody the claimed "discrete first and second channels" where one is "sealed" from the other and contains a "permanently affixed" light guide? The high-level nature of the complaint leaves this as a primary question for discovery and expert testimony.
- A key legal question will concern willfulness and damages: Can the Plaintiff's notice letter, delivered one day prior to patent issuance, establish the knowledge and intent required for willful infringement for conduct that began the moment the patent rights came into existence?
- The extensive post-filing procedural history will be highly relevant. A critical question will be the impact of the inter partes reexamination: How will the cancellation of asserted claim 4 and the confirmation of the remaining asserted claims shape the parties' infringement and validity arguments going forward?