On 8 October 2015, the Central District Court of Israel, Judge Ofer Grosskopf, granted Unipharm Ltd.’s application for an accounting of revenues and profits in Civil Case 33666-07-11, arising from Sanofi’s conduct during examination of a secondary patent application relating to the medicine Plavix. The dispute concerned the period during which a pending patent application exposed generic competitors to uncertainty about future patent litigation.
The decision was an intermediate ruling concerning entitlement to accounts, not the final determination of the amount repayable. The case subsequently reached the Israeli Supreme Court in Civil Appeal 2167/16 (12 July 2021) and an expanded panel in Further Hearings 5679/21 and 5886/21 (26 December 2023). This article examines what the District Court decided in 2015 and why the factual findings became important to the later appeals.
The Parties and the Plavix Patent Background
Unipharm was an Israeli manufacturer and marketer of generic medicines. The defendants included Sanofi, its Israeli subsidiary Sanofi-Aventis Israel Ltd. and CTS (Katzet) Ltd. Sanofi marketed the originator medicine Plavix, a major pharmaceutical product.
Sanofi’s original Israeli patent covering Plavix expired on 3 February 2008. During that patent’s term, generic competitors faced the exclusion conferred by the patent. A later patent application concerned a crystalline form of the drug, called Form 2 in the proceedings, while the original technology was associated with Form 1.
The secondary application remained pending after the original patent expired. Unipharm opposed it. Sanofi ultimately abandoned the secondary application during opposition proceedings, and the immediate patent-law threat associated with potential grant was removed. The commercial and evidentiary significance lay in what occurred before abandonment.
Three Commercial Periods: Patent Exclusivity, Launch at Risk and Competition
The District Court distinguished three periods for analyzing the claimed benefit. First, until 3 February 2008 the original patent was in force and Sanofi benefited from its patent monopoly.
Second, from 3 February 2008 until the secondary application was abandoned in June 2010, generic manufacturers confronted what the proceedings described as a “launch-at-risk” period. If the secondary patent were later granted, sale of a competing product using Form 2, or potentially a product whose material converted to that form, might expose the manufacturer to a future infringement claim.
Third, following abandonment of the secondary application, the relevant potential patent threat was removed. The District Court’s accounting order concerned the period from 3 February 2008 to 20 June 2010, the latter date being the date on which abandonment was approved for the purposes of that order.
For overseas readers, this is an important point: the secondary application was not a granted patent whose infringement was litigated. The economic dispute arose because a pending application could affect investment in, development of and entry into the Israeli generic market.
Unipharm’s Allegations Against Sanofi
Unipharm advanced two related but different propositions. First, it argued that Sanofi filed an application with little prospect of success to manufacture uncertainty and delay generic competition. Second, it asserted that Sanofi knowingly misled the Israeli Registrar of Patents by including incorrect information and withholding material facts about the discovery and technical properties of Form 2.
Unipharm contended that, as a result, it concentrated on developing a generic product using Form 1 and had to devote additional time and resources to avoiding the risk of conversion into Form 2. It sought an accounting because it claimed Sanofi had retained profits through an unjustified extension of the commercial effects of its expiring patent position.
Sanofi rejected the allegation that the secondary patent was filed abusively. It maintained that the application had technical merit, that counterparts were allowed in other countries, and that abandonment reflected the commercial cost of continuing the opposition rather than an admission of invalidity. Sanofi also contested allegations of deliberate deception and causation.
Was the Secondary Application Merely a “Weak Patent”?
The District Court did not find that Unipharm had proved the secondary application was a hopeless or manifestly weak application, or that Sanofi had filed it believing it had no realistic chance of allowance.
Judge Grosskopf observed that evaluating the objective strength of a patent application can be difficult, particularly where the application was abandoned before the contested patentability issues had been resolved. The evidence did not establish the stringent factual proposition that the application lacked any substantial prospect of success.
This distinction is essential to understanding the decision. The claim that Sanofi acted unlawfully merely by filing the secondary application was rejected for insufficient proof. The separate allegation that Sanofi intentionally submitted misleading information and withheld material information was upheld.
The False Example and the French Priority Application
The Court found, on a strong evidentiary basis, that Sanofi had misled the Israeli Patent Office by including Example 1 in the patent application when it already knew the example was incorrect. It also relied on a French priority document despite knowing that it was erroneous and defective for the relevant purposes.
These findings went beyond a typographical or technical mistake discovered in the ordinary course of examination. According to the District Court, the evidence demonstrated knowledge of the problems at the relevant time.
For multinational patent applicants, an asserted foreign priority and examples in an Israeli specification are not merely administrative details. They form part of the factual record against which the Registrar and potential opponents assess patentability, the scope of the claims and the strength of the application.
Failure to Disclose the Discovery and Properties of Form 2
Sanofi also did not disclose relevant circumstances in which Form 2 had been discovered or the relationship between the two crystalline forms, including the fact that Form 1 could not be manufactured in the presence of Form 2 under the circumstances identified in the case.
Sanofi argued that these facts were not within the particular categories of prior-art material required by Sections 18–18A of the Israeli Patents Law and therefore were not subject to the disclosure obligation as it understood it.
The District Court rejected an unduly narrow view of the obligation. Some of the information was relevant to earlier knowledge about producing Form 1, and more broadly, material information bearing on the patent application could not necessarily be concealed simply because it was not within a narrow category of documents enumerated for submission.
The combined effect of incorrect disclosures and omissions was to place the Registrar and generic opponents before incomplete and sometimes conflicting information, potentially increasing the apparent prospects of grant and complicating opposition proceedings.
Did the Misrepresentation Affect Examination and Generic Market Entry?
The Court recognized uncertainty about the precise counterfactual: it could not determine with certainty whether complete disclosure would have caused immediate refusal or a different final outcome for the patent application.
Nevertheless, clearer and accurate information could have simplified the examination and opposition, reduced the difficulty of assessing the application and potentially accelerated the proceedings. For Unipharm in particular, full disclosure might also have affected its willingness to launch a competing drug at risk or to pursue Form 1 and Form 2 development differently.
The Court accepted that the existence of the disputed application delayed and increased the cost of Unipharm’s development of its generic alternative. In the circumstances, it inferred an adverse causal consequence from the misleading presentation and withheld information. The case was not treated as requiring proof that the Registrar would definitely have rejected the application on a particular date.
Patent Law, Competition Law and Unjust Enrichment
The District Court examined three overlapping legal areas. Under patent law, misleading submissions are serious because examination relies substantially on information supplied by the applicant and because rivals make commercial decisions in light of published applications. Sanctions under the Patents Law do not necessarily constitute an exhaustive remedial code that excludes ordinary civil-law claims arising from separate misconduct.
Under competition law, the Court considered the implications of Sanofi’s market position and the artificial prolongation of uncertainty after expiry of the original patent. Its treatment of monopoly abuse was examined and partly reconsidered during the later Supreme Court proceedings.
Under the Unjust Enrichment Law, 5739-1979, the Court considered whether profits retained through intentionally misleading the Registrar, to the competitive detriment of a generic manufacturer, could be recovered as enrichment obtained without lawful justification. This was distinct from the usual patent-law remedy sought by a patent owner against an infringer.
The exact doctrinal relationship was clarified in the 2023 further hearing, where the majority upheld the availability of the unjust-enrichment remedy but differed in its legal reasoning.
The Accounting Order of 8 October 2015
The District Court granted Unipharm’s request for accounts and ordered Sanofi to provide information concerning revenues and profits from marketing Plavix in Israel, including relevant associated companies, for the period from 3 February 2008 until 20 June 2010.
The order specified that the information be provided by 1 December 2015. The Court also offered Sanofi an alternative: accept the claim in full, subject to its right to appeal, rather than provide the accounting. The subsequent exercise of that alternative and whether it could bind Unipharm became a central issue in the later Supreme Court cross-appeal.
The accounting order was not an award of Sanofi’s entire profit. Disclosure of financial data is distinct from the judicial decision on the portion, if any, that should ultimately be restored. The difference matters when reporting outcomes of Israeli patent-related unjust-enrichment cases.
What Happened in the Appeals?
Following the accounting order, Sanofi elected to accept the monetary claim in the amount of NIS 2.6 million for fee purposes. The District Court entered judgment on 4 February 2016. Unipharm maintained that the accounting remedy had been its principal requested relief and challenged the unilateral election.
In Civil Appeal 2167/16, decided on 12 July 2021, the Supreme Court upheld the possibility of unjust-enrichment liability and accepted Unipharm’s cross-appeal concerning the accounting issue. In the further hearing, decided on 26 December 2023, an expanded Supreme Court panel left that operative result intact, by a four-to-one majority, while clarifying the basis and limits of restitution for intentional misrepresentation.
These later rulings must not be retroactively attributed in full to the 2015 District Court. The District Court’s immediate decision addressed the factual findings and entitlement to accounts; subsequent appellate judgments addressed the contested legal basis and how the remedy should proceed.
What Foreign Pharmaceutical Companies Should Take from the 2015 Decision
A pending Israeli patent application can create commercial uncertainty for rivals even when no patent is ultimately granted. The case demonstrates the importance of ensuring that patent specifications, experimental examples, claimed foreign priorities and material information communicated to the Israeli Patent Office are accurate.
For originator companies, the relevant risk is not merely refusal of a claim; intentional deception may later be examined through competition and unjust-enrichment principles. For generic manufacturers, the opportunity to seek an accounting requires more than alleging an overly broad or ultimately abandoned application: factual misconduct and a connection to commercial injury and enrichment must be established.
The original proceedings were in the Central District Court, Civil Case 33666-07-11, Unipharm Ltd. v. Sanofi, decision of 8 October 2015 (Judge Ofer Grosskopf). See the subsequent Supreme Court appeal (2021) and further hearing (2023). For Israeli patent disputes, see Patent Litigation in Israel and Patent Prosecution in Israel.
