Warsaw v. Globus The Saga Continues

On January 26^th, 2011 the United States Court of Appeals for the Federal Circuit rendered a nonprecedential decision in the case of WARSAW ORTHOPEDIC, INC., MEDTRONIC SOFAMOR DANEK USA, INC., MEDTRONIC PUERTO RICO OPERATIONS COMPANY and MEDTRONIC SOFAMOR DANEK DEFFENDORF, GMBH, v. GLOBUS MEDICAL. 

Globus Medical appealed a final judgement by the U.S. District Court for the Eastern District of Pennsylvania relating to the patent infringement suit brought by Warsaw Orthopedic. Warsaw asserted three claims of US Patent No. 6,530,929, “the 929 patent,” and two claims of U.S. Patent No. 7,008,422, “the 422 patent.”  The trial jury found each of the five asserted claims valid and infringed.  Following the trial, Globus moved for a “JMOL.”   JMOL is an acronym for judgment as matter or law, meaning that the asserted claims are invalid as anticipated and are not infringed.   The U.S. District Court for the Eastern District of Pennsylvania denied Globus’s motion without opinion.  On appeal, Globus challenged the judgment of infringement based on the district court’s claim construction. Globus challenged the courts denial of its JMOL based on anticipation.  Anticipation of an invention occurs if the later invention is an adaptation of an earlier patent.  The adaptation would be obvious to a skilled person who would need to exhibit some mechanical skill to develop the same adaptation.  Globus appeal was centered around the court’s construct of the terms at issue on appeal.  The appellate court reversed the denial of motion for JMOL with respect to claim 45 of the “929 patent,” and claim “42 of the 422 patent.”  The appellate court also affirmed the courts denial to claims 47 and 74 of the “929 patent.” And claim 48 of the “422 patent.”  The appeal was remanding to the district court to consider whether the damages award should be revisited in light of the decision.

The two patents in suits are entitled “Instruments for Stabilization of Bony Structures” and share a common specification.  The embodiment or principle pertained to the Sextant.  Globus argued that the claims were limited to the single embodiment disclosed in the common specification.  The court disagreed stating nothing in the specification indicates that the invention is limited to that embodiment.  In addition, the “Summary of the Invention” described various “aspects” of the invention in sufficiently general terms to embrace devices that embody the concept of the invention but are not identical to the particular embodiment described in detail.  Without getting into the minutiae of the suit, the trial court “expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.  Since the specification does not clearly indicate that the patentee intended to deviate from the ordinary, broad meaning of the various terms at issue and limit the scope of the claims to disclose the embodiment, indeed, the specification clearly indicates that the claims are not so limited, therefore rejecting Globus’s restrictive reading of the claims as limited to the preferred embodiment depicted and described in the specification.

Globus challenged the trial court’s claim construction were tied to its theory that claims are limited to the preferred embodiment as described in the specification.  Globus argued that the court gave unduly broad constructions to the terms “instrument” and “inserter” as well as the phrase “an instrument associated with the connecting element.”  Globus had urged the trial court to construe the term “insertion instrument” to mean “a unitary device for implanting a rod or brace that includes a brace inserter, and which has a pivot axis relative to the anchors that is located outside the body.”  On appeal, Globus contends that the term “instrument” as used in the asserted claims, must include at least “two or more support arms (rods) that are pivotally connected to a brace inserter and each of which is connected to an anchor extension, or a brace inserter that is connected to two or more support arms which are pivotally secured to two or more anchor extensions (pedicle screws).”  The trial court rejected this complex formulation and instead construed the term “insertion instrument” to mean “an implement used for inserting something.” (Claims in “422 Patent)  Globus argued that it should be construed as a “unitary device for implanting a rod or a brace that includes a brace inserter and a brace, and which has a pivot axis relative to the anchors that is located outside the body.” Again the court rejected the detailed and narrow definition, but concluded instead that the phrase refers to “an implement operable to place the connecting element in a predetermined location.”  The court thus construed the phrase to mean “an implement for maneuvering the connecting element.   The Appellate Court agreed with Warsaw that the patents do not assign a specific narrow meaning to the challenged terms and that the trial court therefore properly construed those term in light of their ordinary meaning.  Therefore, the Appellate Court rejected Globus’s challenge to the trial court’s construction of particular terms used in the asserted claims upholding the portion of the trial court’s judgment that Globus’s accused system infringes those claims.

Globus argued in the alternative that if the claims are given the broad construction that Warsaw urged for them during the Markman proceedings, the district court should have granted its motion for JMOL of anticipation as to all asserted claims.  The two broadest claims were claim “45” of the “922 patent” and claim “42” of the “422 patent.”  Globus utilized Dr. Paul McAfee as their expert witness, and Warsaw utilized Dr. Scott Tromanhauser.  Globus’s position on claims “45” and “42”was that the claims as construed require only the instrument assist the surgeon in positioning the connecting element so that it connects the first and second pedicle screw.  Warsaw’s position was that the claims require that the instrument be able to place the connecting element (aka rod) without guidance from the surgeon.  Warsaw argued that the Sextant places the connecting rod in the proper orientation without the need for the surgeon to guide the rod between the two screws.  The critical question for purposes of validity inquiry is whether the claims require that the instrument, rather than the surgeon, perform the function of directing the connecting element along the path between the first and second screws.  Warsaw’s argument was that the instrument has an operation and that the claim explained the capability of the instrument not the capability of the surgeon.  Because of disclosure of all elements in claims “45” and “42” the Appellate Court reversed the district court’s denial of Globus’s JMOL for invalidity on the basis of anticipation.  The Appellate Court took a different view as to the remaining claims and affirmed the trial court’s decision to deny Globus’s motion for JMOL with respects to claims “47” and “74” of the “922 patent,” and claim “48” of the “422 patent.”  In sum the Appellate Court reversed the judgment as to claim “45” of the “922 patent” and claim “42” of the “422 patent.”  The Appellate Court affirmed the judgment as to claims “47” and “74” of the “922 patent,” and claim “48” of the “422” patent.  In closing , the Appellate Court remanded this case back to the district court to determine if the calculation of the damages must be reevaluated in light of the modification of the judgment.  The bottom line:

“You win some, You lose some, but you gotta suit up for all of them!”