Nothing Lost but Nothing Gained: Generic Producer Evades Infringement but Fails to Invalidate Patent under §112.

Adele Critchley | April 3, 2014

Alcon Research Ltd., v. Barr Laboratories, Inc.

March 18, 2014.

Before Newman, Lourie and Bryson. Opinion by Lourie.

Summary:

The CAFC reversed the District Court’s judgment that Alcon’s patents lacked enabling disclosure and sufficient written description as Barr had failed to demonstrate that some experimentation was required, let alone undue experimentation.  Barr’s allegations that the claims were “too broad,” the specification was “too limited,” and the art was “too unpredictable,” was not sufficient without evidence to support that undue experimentation was required in order to practice the patented method.

The CAFC, however, affirmed the District Court’s judgment of non-infringement since Alcon had failed to prove that the polyethoxylated castor oil (“PECO)” in Barr’s product was present in a “chemically-stabilizing amount.”

The CAFC denied Barr’s judgment as a matter of law (“JMOL”) and Rule 59(e) (alter or amend a judgment) motions on non-infringement for the two patents that were omitted from the pretrial order and not litigated.

Details:

Barr submitted an Abbreviated New Drug Application (“ANDA”) requesting approval to manufacture, use and sell an ophthalmic travoprost solution as a generic version of Travatan Z ® (Alcon’s glaucoma and ocular hypertension drug wherein the active ingredient is a synthetic prostaglandin analog, travoprost).

At first, Alcon initiated suit alleging that Barr’s ANDA request constituted infringement against six of its patents, U.S. Patent Nos. 5,631,287 (‘287 patent), 6,011,062 (‘062 patent), 6,503,497 (‘497 patent) , 6,849,253 (‘253 patent) 5,510,383 (‘383) and 5,889,052 (‘052).

However, Alcon did not assert the ‘383 and ‘052 patents in their pretrial filings and neither party presented evidence during trial in relation thereto. Accordingly, these patents were not litigated. Subsequent to the first day of testimony, Barr acknowledged that their ANDA drug had infringed the ‘497 and ‘253 patents and that those patents were not invalid, leaving only two in contention the ‘287 patent and the ‘062 patent.

The contested patents were directed to methods of enhancing the chemical stability of a composition containing a therapeutically-effective amount of a prostaglandin, where the method included adding a chemically stabilizing amount of a PECO. The patents covered compositions comprising Travatan Z®.

The decision passed down by the CAFC affirmed in part and reversed in part the District Court of Delaware’s decision.

The CAFC affirmed that Barr’s product did not infringe upon Alcon’s patents since Alcon had failed to show that the amount of PECO present was a chemically stabilizing amount.

In attempting to establish infringement Alcon submitted data from the development stage of their own product. The formulations tested were maintained at pH6-6.1, comprised 0.005% weight by volume of travoprost and varied in concentration of PECO, antimicrobial preservative benzalkonium chloride and buffer solution.

The CAFC held that since Barr’s formulation, as defined in the ANDA specification, was different to those tested by Alcon, the data could not be extrapolated. Specifically, Barr’s formulation according to the ANDA specification would contain 0.004% weight by volume of travoprost, would be maintained at a different pH and would differ in preservatives and buffers. The CAFC held these differences could have a substantial impact on the chemical stability of a prostaglandin in an ophthalmic formulation.

An infringement suit triggered by an ANDA filing under the Hatch-Waxman system pursuant to 35 U.S.C. § 271(e)(2)(A) is based upon a comparison of the subject patent against “the product that is likely to be sold following ANDA approval,” rather than a product already out on the market. However, generic drug producers are bound by strict statutory terms to manufacture, sell and use only that which corresponds with the ANDA’s description.

The CAFC reversed the District Court’s finding of a lack of enablement and written description because Barr failed to make a threshold showing that undue experimentation was necessary to practice the patented method. Barr argued that since the patent document only contained three working examples, did not disclose any data for chemical stability and that the technology is unpredictable, vis-à-vis the effects of pH, buffer concentration and the like, the broad claims were not sufficiently described or enabled.

However, the CAFC disagreed in that the arguments did not prove that those skilled in the art would not be able to carry out the patented method without “undue experimentation.” The CAFC stressed that there is a difference between experimentation that is “undue” to that which is sufficiently routine by an ordinarily skilled artisan. The patent document disclosed step-by-step instructions, exemplary formulations including commercially-available ingredients, and preferred embodiments. Therefore, without evidence to the contrary this disclosure is deemed sufficient.

The CAFC held that the patented method only contained a single step, “adding a chemically-stabilizing amount of a polyethoxylated castor oil to the composition,” in order to provide some increase in chemical stability. The patented method did not require a particular level or magnitude. The CAFC held that Barr showed no evidence that changing any of the variables, i.e. pH, buffer etc., would make the patented method inoperable. Adjusting variables may result in optimizing the patented method but optimization is not necessarily a requirement to practice the patented method.

Moreover, a patent does not need to guarantee that the invention works for a claim to be enabled, an invention may be patented prior to it being actually reduced to practice. The burden is showing that the prophetic examples together with the detailed description are not enabling. This burden was not met.

The CAFC held that the District Court erred in applying the Wands factors as if they were a “generalized tests” for determining whether a patent is adequately described to support broad claims. Rather, Barr had failed to demonstrate that any claimed embodiments would be inoperable to a person of ordinary skill in the art without “undue” experimentation and so the judgment was reversed.

Lastly, the CAFC denied Barr’s motion for judgment as a matter of law of non-infringement of the ‘383 and ‘052 patent. Barr asserted that Alcon had failed to meet its burden of proof for infringement. Notably Alcon did not formally withdraw its claims but, as the patents were not subjected to litigation the District Court’s refusal to enter JMOL was correct.

Takeaway:

Undeniably, it is always prudent that any evidence submitted during litigation to establish infringement should be connected to the alleged infringing product.

Claims that include many variables do not automatically signify undue experimentation. Allegations that claims are “too broad,” based upon a specification that is “too limited,” in a field where the art is “too unpredictable,” may now require establishing that embodiments of the claims may be inoperable without experimentation, and that experimentation would be undue and not routine. Moreover, adjusting variables that may result in optimizing the claimed invention but are not required to practice the claimed invention, do not necessarily equate to undue experimentation.

The eight factors stated by In re Wands are not the generalized tests for deciding whether a patent disclosure is enabled and sufficiently described.

 

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