In the 1990’s, Peter Andrulis and Murray Drulak discovered that thalidomide,* combined with an alkylating agent such as melphalan, could be effective in treating certain types of cancer. US Patent 6,140,346 subsequently issued, including the following claim which the eponymous Andrulis Pharmaceuticals asserted against thalidomide manufacturer Celgene. Earlier this week, the CAFC brought an end to that claim, upholding a lower court ruling that the only asserted claim is invalid for indefiniteness, with a single word opinion. Ultimately, a legal battle that expended tens, if not hundreds, of thousands of words to determine the meaning of a sixty word claim came to an end with just one simple word – Affirmed.
This result is generally referred to as a “Rule 36 judgement,” referring to the CAFC procedure rule that allows the court to dispose of a case by affirming the lower court’s decision without producing an opinion. But to understand how this impacts inventors and patent owners, it’s necessary to first understand the claim and the decision under review itself. The only asserted claim in this case was Claim 2 from the patent:
2. A method for the treatment of neoplastic diseases in a mammal which comprises administering to said afflicted mammal enhanced therapeutically-effective amounts of thalidomide in combination with effective amounts of other alkylating agent selected from the group consisting of [a whole bunch of polysyllabic chemicals that I can’t pronounce] wherein said neoplastic diseases are sensitive to said enhanced combination.
During claim construction, Judge Richard Andrews noted that the words “enhanced” or “enhanced combination” could refer to enhancement that is “less than additive, additive, or greater than additive.” Although Andrulis argued that “enhanced,” in context, could only mean “greater than additive,” Judge Andrews noted that if the other possibilities are plausible constructions, then the claim would be rendered invalid for failing to particularly point out and distinctly claim the invention.
During prosecution, the examiner pointed out that if the claims showed a “greater than additive” effect, then such claims would be allowed over the prior art. In response, Andrulis added the word “enhanced” to the claims. The examiner accepted the change and issued the patent. Obviously, this implies that the examiner believed that “enhanced” was equivalent to “greater than additive,” leading us to the one and only, proper construction, right? No so fast …
As they are known to do, Andrulis’ patent attorney made an alternative argument too. Taking inspiration from famous trial lawyers Demi Moore and Kevin Pollack, Andrulis “vigorously disagree[d]” with the examiner’s underlying premise about requiring a “greater than additive” effect to overcome the prior art in the first place. Judge Andrews aptly noted that if the prior art “did not teach this combination, then the applicant did not need to overcome the rejection by amending the claims” in the first place. Consequently, the Judge refused to conclude that “enhanced” was merely a synonym for “greater than additive,” leaving only one viable option: declaring the claim indefinite.
To recap, an inventor disagreed with the examiner’s opinion, but nevertheless amended his claim language in order to accommodate the examiner’s opinion. The examiner accepted the change to the claim language and issued the patent. But, in the Judge’s view, the inventor didn’t really mean it, allowing him to basically ignore the amendment altogether.
However, an even greater injustice was to befall Andrulis. Reasonable minds may disagree about the relevance of Andrulis’ alternative argument. Personally, it should not matter what the inventor did or did not “need” to do; rather, it should only matter what he did. In this case, Andrulis amended the claim language, overcoming the rejection. Thus, the question of whether Andrulis “need[ed] to overcome the rejection by amending the claims” is irrelevant, and the interpretation so obviously accepted by the examiner should be adopted here. Nevertheless, a reasonable person might also conclude that it is equally likely that the examiner was persuaded by Andrulis’ vigorous disagreement and decided that a “greater than additive” effect was not necessary to make the invention patentable. Of course, if you believe that, the sound you just heard is every patent attorney in the country turning their head to look at you with haughty derision. Nevertheless, Andrulis, at a minimum, deserved a direct answer and explanation as to why this alternative argument should automatically control an outcome so very likely counter to the examiner’s understanding at the time.
Almost as much, the public deserved a precedential opinion weighing these two possible outcomes, their rationales and consequences, to set a rule going forward to guide both future litigants and patent prosecutors who are faced, daily, with the decision of whether to continue to argue with examiners or capitulate. As it turns out, lack of written decisions are a growing problem at the CAFC, recently highlighted by Gene Quinn. Former Chief Judge Rader told Quinn that only about 1/3 of cases should be affirmed without an opinion, such as the result Andrulis received. However, Quinn quoted recent statistics that show the current rate of such decisions is 43% in appeals from district courts, and 50% in appeals from the USPTO! This revelation caused Quinn to correctly conclude that “use of a Rule 36 judgment presents a real and growing problem for the patent community. Indeed, the right to a full, fair and thoughtful appeal seems to be almost completely compromised.” He rhetorically asks, “Since the earliest days of our formalized education we have been told repeatedly to ‘show your work,’ but here at the pinnacle of our Justice system judges are allowed to summarily reject an appeal without as much as an explanation?”
A Rule 36 judgement may also be a death knell preventing a successful Supreme Court petition, as a complete record is utterly lacking with the losing party being left to guess as to how easily or not the adverse result might be overcome. The growing percentage of Rule 36 judgements is likely the result of an ever-increasing caseload thanks to the America Invents Act (causing an increase in appeals from the USPTO) and decisions like Alice Corp. v. CLS Bank (encouraging more frequent early dispositive motion practice). Nevertheless, it is inventors who suffer both directly (such as Andrulis, and others like them, being left without guidance from the appeals court on why it’s patent was taken away) and indirectly (the rest of patent owners who are left wondering whether an otherwise particular and distinct claim will be eviscerated by a spurious reading of their file history.
*If thalidomide sounds familiar, you might be a Billy Joel fan.