Fosamax® Daily: Appeals Court Will Rule for Merck

June 3, 2003

INTRODUCTION

On June 3, 2003, the Court of Appeals for the Federal Circuit heard oral argument in the appeals of Teva and IVAX’s from the Delaware federal trial court’s decision granting Merck exclusivity for its daily dose Fosamax^® until August 2007.  Judge Farnan’s November 2002 decision held that Merck’s U.S. Patent 4,621,077 (which has a single claim for a method of treating osteoporosis by the application “alendronate,” [the active ingredient in Fosamax]) was (1) valid, (2) infringed by Teva and IVAX, and (3) properly extended to 2007 by the U.S. patent office.

After reviewing the parties’ appellate briefs and watching oral argument on appeal, Verdict predicts that the appeals court will affirm Merck’s trial court victory.  A decision should be issued in late 2003.

TRIAL COURT DECISION

The Delaware Court held a four-day trial in late 2001 and issued a 59 page decision on November 4, 2002, in which Judge Joseph Farnan held that the ‘077 patent:

1. Covered the treatment of osteoporosis using alendronate in both its acid and sodium salt forms;
2. Covered the treatment of osteoporosis alone, not only in combination with urolithiasis;
3. Was not invalid on grounds of anticipation by the ‘761 patent;
4. Was not invalid on grounds of obviousness based on ‘761, ‘598, and 108 patents;
5. Was literally infringed by both Teva and IVAX; and,
6. Was properly extended to 2007 by the patent office under the Patent term Restoration Act.

TEVA and IVAX’s POSITIONS ON APPEAL

The generics contend that Judge Forman should be reversed because:

The judges’s claim construction improperly construed alendronate[1] acid to include alendronate sodium salt because:

1. He never considered the ordinary meaning of the term acid in the claim language;
2. He ignored the detailed description of the invention which distinguishes between the acid and sodium forms.

The judge’s rulings on invalidity (anticipation) were improper because he:

1. Limited the analysis of anticipation to the ‘761 patent;
2. Excluded testimony of those “skilled in the art”; and,
3. Relied upon contrary and superfluous teachings in the ‘761 patent.

The judge’s rulings on infringement that limited the patent to the acid form:

1. Precludes literal infringement; and,
2. Limits the amendments of the claim under the doctrine of equivalents.

The judge should have overruled the extension because:

1. The patent does not cover the sodium salt form of the active ingredient in Fosamax;
2. The term extension law is strictly limited to patents claiming methods of using a product; and,
3. The court improperly deferred to the patent office.

MERCK’S POSITION ON APPEAL

Merck contends that the trial court decision should be affirmed on appeal because:

• The judge’s claim construction:
  • Correctly interpreted the acid/salt issue using the standard of a “person of ordinary skill in the art;”and,
  • The “biological” treatment portion of the patent does not distinguish between acid and salt forms and includes the latter in the former.

• Regarding validity,
  • The generics’ failure to appeal obviousness moots their arguments in support of anticipation; and,
  • The court correctly found that the ‘761 patent did not anticipate as a matter of case law and because there is no “implicit anticipation.”

• As to infringement,
  • There was no limiting amendment; and,
  • The trial court’s claim construction underscores the validity of the patent office’s term extension.

ASSESSMENT OF THE CASE ON THE BRIEFS

The generics’ appeal briefs made two arguments that were unsuccessful at trial:

1.  Interpretation of the claim requires the simultaneous treatment of osteoporosis and urolithiasis; and,

2. Invalidity on grounds of obviousness based on the combination of three Blum prior art patents.

Merck’s brief argued that if there is no obviousness there can not be anticipation.  Merck’s briefs successfully rebutted the generics’ contention that acid is not salt.  Thus on the briefs alone, the careful reader would have given Merck a slight edge on the merits of the key arguments.

Merck has the advantage on claim construction (that sodium salt is included in the alendronic acid) based upon:

a) The internal structure of the patent itself; and,
b) The helpful opinion of the patent office on term restoration.

Merck has the advantage on the validity issue because the generics have the burden to show anticipation by clear and convincing evidence and the court of appeals defers to the trial court’s findings of fact.

Merck’s argument that generics cannot argue anticipation because they have conceded non-obviousness is unpersuasive but the court will not need to decide this issue.

The best argument for the generics is that the amendment of the claims during prosecution eliminated the possibility of infringement under the doctrine of equivalents, but the court will not reach the argument if it upholds the district court’s claim construction; and,

Merck has the advantage on the term restoration issue, because:

a) The district court made an independent finding that ratified the patent office’s determination;

b) The court generally avoids denigrating the patent office; and,

c) This issue is intertwined with and can be mooted by the court’s holding on claim construction.

ORAL ARGUMENT

The three-judge appellate panel included:

1. Chief Judge Mayer, a Reagan appointee;

2. Pauline Newman, a Reagan appointee and an intellectual property lawyer; and

3. Sharon Prost, a 2001 Bush appointee and former labor lawyer.

Oral argument did not add anything of substance that was not in the parties’ briefs.  Their political backgrounds may tend to favor Merck.

The panel’s questions and body language seemed to favor Merck.  While the Chief Judge asked no questions, Judge Newman asked a few, and Judge Prost was vocal.  The questions and body language leaned literally and figuratively towards Merck and away from the generics.

Judge Prost interrupted Teva’s counsel, arguing the claim construction issues, challenging the argument that “ordinary meaning” (of acid) was undisputed, interrupting the answer by citing Table 6 of the patent, and following up with a third question hostile to the generics’ position.

Judge Newman asked IVAX’s lawyer to explain what language in the ‘761 showed anticipation of treatment of osteoporosis.  This question showed an appreciation of Merck’s position that disclosure of use of bisphosphonates, a class of drugs that includes alendronate, in “pharmaceutical preparations” does not equate to the patent’s claim applying alendronate to treat osteoporosis.  Judge Newman also challenged IVAX counsel’s statement that Merck acknowledged differences between acids and salts, anticipating Merck’s retort that this related to differences in their methods of synthesis, not in their use in treating osteoporosis.

Judge Prost and Judge Newman asked questions of Merck’s counsel that were in the areas of Merck’s strengths and allowed Merck to re-enforce the points the judges had already made themselves during their questioning of the generics’ counsel.  The judges then laid back and allowed Merck to use the balance of his time, uninterrupted, on detailed legal arguments about:

• The interplay of the term restoration law and the patent law; and,
• How to apply the court’s prior case law to its decision here.

The generics’ reply time was so divided between lawyers, that their points were virtually lost in the shuffle of exchanging places at the lectern.

SUMMARY

1-    As the trial court victor who was favored by a comprehensive opinion by the trial court, Merck began the appeal procedurally ahead.

2-    Merck sustained its procedural advantage with its strong brief.

3-    The panel of judges was ideologically predisposed to Merck’s case.

4-   Two of the three panel members were hostile to the generic positions.

5-   By dividing their time between two lawyers (unusual in appellate arguments), the generics diluted their arguments.

Accordingly, Verdict predicts that the Federal Circuit will affirm the decision of the trial court and maintain Merck’s exclusivity on daily dose Fosamax until August 2007.

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[1] The terms alendronate and alendronic acid developed after the patent to refer to “4-amino-1-Hydroxybutane-1, Bisphosphonic Acid.  The generic appellants always use the chemical name in the patent even when qualifying the sodium salt form.  Merck’s brief defines alendronate and alendronate sodium in a definition section as the same chemical but then uses the alendronate short hand.