Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D. Mass. 2017)

District Court Finds Claims Directed to Method for Analyzing Enoxaparin Sample to Be Patent Eligible

By Donald Zuhn --

Last month, in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., District Judge Nathaniel M. Gorton of the U.S. District Court for the District of Massachusetts allowed a motion for judgment as a matter of law filed by Plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc. ("Momenta") contending that two affirmative defenses asserted by Defendants Amphastar Pharmaceuticals, Inc. and International Medication Systems, Ltd. ("Amphastar") were inapplicable.  Amphastar had asserted the affirmative defenses of patent ineligible subject matter and indefiniteness in response to Momenta's claim that Amphastar's sale of generic enoxparain products infringed U.S. Patent No. 7,575,886.  The instant post addresses Amphastar's affirmative defense of patent ineligible subject matter.

The '886 patent is directed at a set of manufacturing quality control processes that ensure that each batch of generic enoxaparin includes the individual sugar chains characteristic of enoxaparin sodium, which is marketed under the brand name LOVENOX.  Representative claim 1 of the '886 patent recites:

1.  A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising:
    providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes;
    using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that includes β-eliminative cleavage with a benzyl ester and depolymerization;
    making a determination about the enoxaparin sample based upon a comparison of the determination of the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 to a reference standard for enoxaparin, and
    determining the presence of the structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1 in a second batch of enoxaparin, to thereby analyze the enoxaparin sample.

Two days after Amphastar received FDA approval to market its generic enoxaparin product, Momenta filed a complaint alleging that Amphastar infringed the '886 patent by manufacturing generic enoxaparin for commercial sale using its patented method.  After twice reaching the Federal Circuit (see "Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)" and "Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)"), the case returned to the District Court where Amphastar moved for summary judgment of invalidity (on the grounds of lack of patent eligible subject matter and indefiniteness) and non-infringement, and Momenta cross-moved for summary judgment of dismissal of the equitable defenses of waiver and estoppel.  In a decision issued in June (see Memonrandum & Order), the District Court denied the motions filed by both Amphastar and Momenta.

With regard to Amphastar's motion for summary judgment of lack of patent eligible subject matter, Amphastar argued that each of the four steps of the claimed method for analyzing an enoxaparin sample involves patent ineligible subject matter.  In particular, Amphastar contended that the first step of the claimed process involves the digestion of enoxaparin, which is a law of nature, the second step involves the identification and separation of that natural process, and the third and fourth steps involve the comparison between the tested product and a standard product, which are comparisons of abstract ideas.  In response, Momenta countered that the exhaustive digestion of enoxaparin in the first step, which requires exposure of the enoxaparin sample to a chemical cocktail for a certain time and at a specific temperature, does not occur naturally, and that the process results in a mixture of long and short sugar chains that do not individually exist in nature.  Momenta also disputed Amphstar's assertion that the second, third, and fourth steps of the claimed process rendered the claimed process patent ineligible.  In denying Amphastar's motion, the District Court determined that after "[v]iewing the facts in the light most favorable to Momenta," Momenta had persuaded the Court "that the '886 patent '[is] directed to a new and useful method' of ensuring the quality of enoxaparin."

Turning to Momenta's motion for judgment as a matter of law on Amphastar's affirmative defense of patent ineligible subject matter, the District Court once again faced the issue of the patent eligibility of asserted claims.  The Court began by outlining the two-step framework for determining patent eligible subject matter set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012).  In the first step, the Court must determine whether the claims are "directed" to a patent ineligible concept, such as a natural law, natural phenomenon or abstract idea, and if the claims are so directed, then the Court must determine whether the elements of the invention "transform" the claims into an application eligible for a patent.  In allowing Momenta's motion, the District Court determined that:

Because the '886 patent "[is] directed to a new and useful method" of ensuring the quality of enoxaparin and involves a series of laboratory steps rather than a law of nature or abstract idea, this Court concludes that the asserted claims involve patentable subject matter. See CellzDirect, 827 F.3d at 1048.

Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D. Mass. 2017)
Memorandum & Order by District Judge Gorton

Comments

[skeptical]

How does this decision square with Prometheus?

Could not the exact same step-by-step conclusions of THIS court be obtained if one were to look at the actual claims found by the Supreme Court to NOT be patent eligible in the case heard by the Supreme Court?

What type of test do we have that unleashes such seemingly arbitrary results?

[EG]

Hey Don,

What's really sad is that Momenta's motion, prior to the broken and nonsensical Mayo/Alice framework, would have been not only laughable but possibly sanctionable.

[Paul Cole]

@ Skeptical

If you look at positive compliance with the eligible "process" category of Section 101 in Prometheus v Mayo, the two novel features were mere items of information about upper and lower values defining a safe therapeutic window for thiopurine drugs and not involving the hand of man or in themselves achieving a transformational result based on these values. There was no direction in the claim e.g. to adjust patient dose to maintain the blood level within the therapeutic window (not a straightforward task with this particular class of drugs owing to patient metabolism and time variability). The remaining two features were administration and analysis steps which were admitted to be not novel in the specification as originally filed.

The Supreme Court was therefore faced with a combination of two clearly ineligible features with two admittedly old features, and there was no credible argument for a transformational result even if they were considered together as an ordered combination, since the skilled person was merely instructed to carry out a known analysis in the context of known therapeutic window, and was provided with items of information without being told what to do with them.

That is essentially why the Court decided as it did, and there is not much wrong with their reasoning. It would be helpful, however, if more analysis of this and other cases were carried out by attorneys capable of distinguishing the underlying rule of law, or as we trained lawyers say the ratio decidendi, of a case from dicta which are merely persuasive but might not for various reasons be followed in subsequent cases.

As has been said, the present case appears to be a new laboratory analysis, and its facts appear to be clearly distinguishable from those in Mayo.

[skeptical]

Mr Cole,

No one (including myself) is arguing against YOUR careful analysis.

Bottom line though is that the courts (and essentially your advice to attorneys is moot, as it is the courts that have the final say) that ARE doing otherwise.

The words "I told you so" echo in the rafters...

[Paul Cole]

@ Skeptical

In the UK, members of the patent bar will have, as in the US, a technical degree, a degree in law and years of professional experience. The judges in the Patents Court and IPEC are exclusively drawn from the patent bar, and therefore have had decades of relevant experience before their promotion to the bench. Two of the judges in our Court of Appeal are promoted patent judges and have added years of judicial experience to their years in practice. In our Supreme Court, Lord Neuberger, though a generalist, had a degree in chemistry from Oxford and was therefore in a good position to decide cases involving technical issues.

In the Federal circuit, significant decisions on eligibility continue to be made by judges with no technical training, no training in patent law and no experience of practice in this area. The competence of a judge with a distinguished legal and academic career, but whose practice was concerned exclusively with international trade before joining the Court to deal with issues so far outside that person's prior experience is, to say the least, open to question. Other members of the court seem to have unwelcome prejudices on 101 issues. Absent action by Congress, all that can be done in new cases is to explain the facts and the relevant law with clarity and firmness, bearing in mind that we may be addressing an audience with less knowledge and skill than the average one-year associate in one of our firms.

A difficulty that has to be faced is how to educate the judges in the properly applicable elementary principles of law (which it is easy to overlook because they are so familiar to experienced practitioners) in a brief of reasonable or indeed permitted length.

[Skeptical]

Mr. Cole,

I would dare say that you are seeking a solution where none may be found.

In other words, EVEN doing as you suggest, the courts will STILL do as they currently do.

Your aim is (sadly and merely) ineffectual. Focusing so much effort on the "but what else as attorneys can we do" aspect really (in my humble opinion) is NOT the best aim for our advocacy efforts.

This is NOT to say that efforts such as yours are not a part of a solution - it is that such is not - and cannot be - the major thrust of a solution.

[Paul Cole]

@ Skeptical

There is nothing else that we can do for our clients NOW. If we are concerned with the next set of claims that we submit to the USPTO, or the next brief we submit to the Federal Circuit, we have to deal with the law as presently expressed and explain why the case before the Examiner or judge ought to succeed and not be arbitrarily dismissed an ineligible.

It is just possible that detailed and careful argument might persuade some judges to change their minds. It was reported that a picture of some girls in mini-skirts in Kabul in the 1970's persuaded President Trump to continue US efforts in Afghanistan. If we continue to argue logically and intelligently from the facts and the established law we might just come upon a tipping point that really works and changes things for the better. I would rather do that than do nothing.

Which is not to say that the alternative legislative approach and wider campaigning are devoid of merit. But being based in Europe there is little I can or even should do over here to influence events. At the AIPLA Annual Meeting every year in October there is a reception for those who contribute to the political campaigning efforts of that distinguished organization. But as an alien, I am prohibited from attending and consequently denied a free glass of wine because I might corrupt the US political process. That used to be a source of amusement but nowadays is perhaps also a source of sadness.

[skeptical]

"There is nothing else that we can do for our clients NOW."

This is exactly the wrong message to be sending.

"I would rather do that than do nothing."

That is a false set of options.

"Which is not to say that the alternative legislative approach and wider campaigning are devoid of merit. But being based in Europe there is little I can or even should do over here to influence events."

But that is exactly what you are doing with your proselytizing of the false set of options and the sending the wrong message.

Your message is taking the place of a better first actions - offering sound, but merely secondary actions as a replacement for those first actions. As an alien, you may be prevented from attending political functions, but every time you speak up - you ARE being politically involved.

I certainly "get" that you have a valuable message as to certain aspects of "best practices."

But when you parade those as THE answer to the questions plaguing our system, and your THE answer displaces other answers, then you are part of the problem because you are distracting from those other items that you may (and I dare say actually are not) "limited" in advancing.

As to the AIPLA, your not being associated (for whatever reason) should be considered a good thing. Have your read their Oil States brief?