PATENT DECISIONS


possibly ascertain the boundaries of the claims. Teva countered that the prosecution history made it clear that ‘molecular weight’ should be construed as Mp.


Aſter considering the patent specifications,


prosecution histories, prior art and expert testimony, the district court agreed with Teva, finding that the phrase ‘molecular weight’ was not indefinite, the claims in all nine patents were valid and Sandoz’s generic drug infringed those claims.


Te district court issued an injunction enjoining the FDA from approving any ANDA for generic versions of Copaxone and enjoining the defendants from making, using, offering for sale, or selling generic Copaxone until September 2015, the date of patent.


the latest expiring asserted


Sandoz appealed to the Federal Circuit, arguing again that


the phrase ‘molecular weight’ was


indefinite and that the claims were invalid. Te Federal Circuit expressly heard the case de novo (afresh) without giving deference to the district court’s factual determinations. Te Federal Circuit unanimously reversed the district court and held that the patent was invalid because the term ‘molecular weight’ was indefinite.


In doing so, the Federal Circuit reviewed again all of the evidence before the district court and came to the opposite conclusion. As a result of the Federal Circuit’s decision, the important Teva patents are invalid and Sandoz can enter the marketplace a year before the patent would have expired.


Appealing to a higher court


Following the Federal Circuit’s decision, Teva filed a petition for writ of certiorari with the US Supreme Court. Te Supreme Court granted the petition in order to determine whether the Federal Circuit should review the construction of patent claim terms de novo, as the Federal Circuit did in this case, or only for clear error.


Te general question before the Supreme Court is what level of deference, if any, the Federal Circuit should accord to district court judges who have made rulings on the scope and meaning of the claims in the patents. For years, the Federal Circuit has reviewed the decisions on a de novo basis—that is with no deference.


Teva is challenging the standard of review and contending that more deference is due to district court judges who invest time in hearing all of the evidence and the arguments. Absent a reversal by the Supreme Court, the Teva patent will stand


www.lifesciencesipreview.com


as invalidated, with Teva losing its exclusive position now rather than in 2015.


Te specific question before the Supreme Court suggests that close attention will be paid to what the Federal Circuit considers a legal or factual question and whether the review afforded to that question is appropriate. Rule 52(a) of the Federal Rules of Civil Procedure provides that in matters tried to district court, the court’s “findings of fact ... must not be set aside unless clearly erroneous”.


With this point of reference, the Supreme Court granted certiorari to determine: “Whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as rule 52(a) requires.”


Te arguments showed a Supreme Court that appears split on the issue, with several judges, including Chief Justice Roberts and Justice Alito, appearing disinclined to change the system of review that has been in place for some time. Justices Kagan and Breyer, however, appear to lean in favour of giving deference to the decisions of district court judges as is done in many other areas of federal law.


Justice Breyer posits the notion that at least in technical cases, a district judge is the one who “sat there the whole time and listened to these experts talking ... And that, I think, is a very powerful reason for saying, in a technical case, don’t overturn the judge’s factual findings” (unless they are clearly in error).


A ruling is expected no later than the end of June 2015. It is possible that the Supreme Court will affirm the de novo review standard for claim construction, which has been used by the Federal Circuit for many years. With the recent spate of high-profile Supreme Court reversals of the Federal Circuit in the 2013/2014 term, it would appear unlikely that the Teva decision will be simply affirmed. Te Federal Circuit decision was based on long-standing precedent and was driven by its goal of ensuring uniform claim construction. Tere would be no need for the Supreme Court to affirm what it has permitted for many years.


Alternatively, the Supreme Court could hold that claim construction is a question of fact, not law, and that the ‘clear error’ standard of review should apply. Perhaps the most likely decision may be


that


decisions are a mixed question of fact, and that


claim construction law and


the ‘clear error’ standard will apply to factual determinations and de novo Life Sciences Intellectual Property Review Volume 2, Issue 1 25


reviews will be afforded to legal questions. Implementing a mixed review standard would likely be difficult.


If the standard of review does change, there could be significant changes in the manner in which patent litigation is conducted. Te elimination of de novo review would take away the ‘second bite of the apple’ previously guaranteed to the party whose claim construction and related infringement and validity arguments were rejected by the district court. With no ‘do-over’, parties may expend significantly more funds upfront to win at the district court.


With new deference accorded to district courts, the Federal Circuit’s role would also become more analogous to that of other appellate courts, with a narrower focus on the decisions made. Tis is contrary to the very reason the Federal Circuit was created: a court with expertise in patent law and the universal application of that law.


Te nature of the change, if any, will depend heavily on what


the Supreme Court decides


and what direction the Supreme Court gives for implementation of the review standard. 


Felicia Boyd is a partner at Barnes & Tornburg. She can be contacted at: felicia.boyd@btlaw.com


Felicia Boyd is a partner at Barnes & Tornburg’s Minneapolis office and is co-chair of the firm's intellectual property department. Her practice focuses on complex intellectual property litigation, and she has led cases on a large variety of


claims covering trademarks and trade dress.


patents, copyright,


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