Holding
In Westminster Pharmaceuticals, LLC, v. LPRI France,1 the Patent Trial and Appeal Board found that Westminster did not show that it would likely prevail with respect to at least one of the challenged claims and denied the institution of inter partes review under 35 U.S.C. § 314(a) for U.S. Patent No. 8,183,227 B1.
Background
Westminster challenged the '227 patent, which claims a composition containing high doses of vitamin D, iodine, vitamin B, and other vitamins formulated to address vitamin deficiencies in pregnant women.
Representative Claim 1
- A composition consisting of vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 μg, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 μg, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, omega 3 fatty acids comprising DHA in an amount of about 200 mg, and one or more pharmaceutically acceptable carriers.
Obviousness
Westminster asserted that the claims of the '227 patent were unpatentable as obvious over various combinations of the following prior art references: (1) Bentley et al., (2) Bischoff-Ferrari, (3) Koletzko et al, (4) McCullough, and (5) MPR. This article focuses on grounds 1 and 2, which relied on Bentley as the primary reference, and grounds 5 and 6, which relied on MPR as the primary reference.2
Obviousness grounds 1 and 2:
Westminster argued that the challenged claims are unpatentable as obvious over Bentley, Koletzko, and either Biscoff-Ferrari or McCullough. Id. at *12. Westminster argued that a person of ordinary skill in the art looking to develop a prenatal vitamin would have used the ingredients and dosages disclosed by table 1 in Bentley. Id. Westminster argued that the table disclosed all the recited ingredients and dosages of claim 1 with three differences: (1) the table recited a vitamin D dosage 600 IU lower than claim 1, (2) the table did not include DHA, and (3) claim 1 lacked calcium whereas table 1 included it. Id. at *13-14. To overcome these deficiencies, Westminster cited Biscoff-Ferrari and McCullough as support for increasing the vitamin D dose, and Koletzko for including DHA in a prenatal vitamin supplement. Id. at 15.
The PTAB rejected Westminster's arguments, finding that the table disclosed in Bentley did not disclose standard prenatal compositions and the cited art failed to cure the differences between the table and claim 1.
The PTAB agreed with LPRI that Bentley's table 1 does not describe a standard prenatal vitamin composition but instead provides an aggregate of dose ranges of nutrients that can be used in prenatal vitamins. Therefore, to arrive at claim 1's composition, a person of ordinary skill in the art would have to do more than select a dose amount from the ranges disclosed by the table. Id. at *15-16. The PTAB found the facts of this case similar to Genetics Institute,3 in which the Federal Circuit declined to apply a presumption of obviousness where the prior art disclosure contained over 68,000 variants. Id. at *17. In the present case, there were 524,288 possible compositions that could be formed by combining one or more of the 19 nutrients listed in Bentley's table 1 and Westminster failed to explain why a person of ordinary skill would have been motivated to invent the composition of claim 1 out of the over 500 thousand potential compositions encompassed by Bentley's table. Id. at *17-18.
Next, the PTAB held that Biscoff-Ferrari and McCullough failed to explain why a person of ordinary skill in the art would have increased the dose amount of vitamin D recited in Bentley to 1000 IU. Id. at *20-21. The PTAB explained that although Biscoff-Ferrari recommends a minimum vitamin D dose of 1000 IU, it does not address pregnancy or prenatal development. Id. Instead, Biscoff-Ferrari focuses its study on cancer patients and post-menopausal women. Id. at *21. Citing expert testimony, the PTAB held that one of ordinary skill in the art would not use Biscoff-Ferrari to develop a prenatal vitamin because the vitamin D intake requirements of pregnant women are different from the vitamin D intake requirements of elderly women. Id. Furthermore, Biscoff-Ferrari taught that only 50% of the adult population would reach the ideal vitamin D levels by taking 1000 IU per day, and the PTAB held that Westminster failed to explain why a person of ordinary skill in the art would pursue a dose that only worked for 50% of the population. Id. at 21-22. Lastly, the PTAB was not persuaded that McCullough would have motivated a person of ordinary skill in the art to increase the vitamin D dose in Bentley because McCullough expressly called for more research to evaluate the recommended dose of 1000 IU. Id. at *23-24. McCullough states that the recommended dose may be 1000 IU or higher. Westminster failed to explain why one would have understood such teachings as an instruction to use a dose of exactly 1000 IU. Id. at *24-25. Accordingly, the court held that neither Biscoff-Ferrari nor McCollough would have motivated one of ordinary skill in the art to increase the vitamin D dosage recited by Bentley to 1000 IU. Id. at *26.
The PTAB also held that Westminster failed to show that a person of ordinary skill in the art would have removed calcium from Bentley's compositions. Id. at *27. Westminster argued (1) it was commonly known that calcium has an inhibitory effect on iron absorption and (2) including calcium would have made the supplement too large because calcium occupies more bulk space. Id. The PTAB rejected both arguments, pointing to expert testimony that explained how long-term studies do not show that calcium has an inhibitory effect on iron absorption. Id. The PTAB further cited sixteen pre-natal vitamins that contain calcium, showing that calcium does not always result in prohibitively large pre-natal vitamins. Id. at *28.
In conclusion, Westminster failed to show that a person of ordinary skill in the art would have been motivated by Bentley to invent the composition of claim 1 out of the over 500 thousand potential compositions disclosed in Bentley's table 1. Furthermore, Westminster failed to show why a person of ordinary skill in the art would have used the cited prior art to increase the vitamin D dose recited by Bentley to 1000 IU and to remove calcium from the composition. Accordingly, the PTAB held that Westminster failed to show a reasonable likelihood of establishing that claim 1 was unpatentable as obvious over Bentley, Koletzkom, and either Bischoff-Ferrari or McCullough. Id. at *28.
Grounds 5 and 6
Westminster argued that the challenged claims are unpatentable as obvious over MPR, Koletzko, and either Biscoff-Ferrari or McCullough. Id. at*29. According to Westminster, a chart contained in MPR included all 16 ingredients recited by claim 1 of the '227 patent, 10 of which were disclosed at the exact dosage used in claim 1. Id. The chart also disclosed four nutrients not recited in claim 1: calcium, vitamin B5, biotin, and selenium. Westminster repeated its arguments used in grounds 1 and 2 for why it would have been obvious to exclude calcium and further argued that it also would have been obvious to exclude the remaining ingredients because they are rare and uncommon in prenatal vitamins.
The PTAB disagreed. The PTAB first cited its analysis in grounds 1 and 2 to explain why Biscoff-Ferrari and McCullough fail to lead a person of ordinary skill in the art to exclude calcium from a pre-natal vitamin. Id. at *30. The PTAB next explained how MPR lists twenty pre-natal vitamins and their ingredients, emphasizing the fact that not one single pre-natal vitamin listed contains the same sixteen nutrients recited in challenged claim 1, let alone in the same amounts. Id. at*32. Westminster offered no rationale for why one of ordinary skill in the art would make the selections needed to reach the claimed composition. Id. at *34. Further, the PTAB explained that although some of the dosages of the claimed ingredients are listed by some pre-natal vitamins in the chart, other pre-natal vitamins list different dosages for the same ingredients, and Westminster failed to explain why one would rely on certain pre-natal vitamins and ignore others. Id. at *35. Accordingly, the PTAB held that Westminster failed to show that a person of ordinary skill in the art would have been motivated by the chart in MPR to invent the composition of claim 1. Id. at *36-37.
Takeaways
This case serves as a reminder that when challenging composition claims reciting a list of ingredients and concentrations, challengers should provide a rationale for why one of ordinary skill in the art would choose ingredients from a prior art list in the claimed amounts to make the claimed composition. In this case, Westminster tried to use a table and chart that disclosed most of the ingredients recited in claim 1. But the PTAB rejected Westminster's arguments, in part, because Westminster offered no rationale for why a person of ordinary skill in the art would have been motivated to choose the ingredients from the table and chart to make the claimed composition.
Furthermore, when challenging composition claims reciting a list of ingredients and concentrations, challengers should use prior art references that limit the total possible combinations. In this case, the PTAB determined that the prior art disclosed over 500 thousand possible combinations, without providing any motivation to choose the claimed ingredients and, therefore, Westminster failed to establish a presumption of obviousness.
In lieu of relying on prior art references disclosing large numbers of possible combinations, challengers may consider instead using expert testimony to supplement the implicit teachings of a prior art reference. For example, in the recent Liquidia IPR,4 none of the cited prior art expressly disclosed the claimed dosage range or provided the amount of solution used with the recited concentration of the claimed drug needed to calculate the dosage. The PTAB nevertheless allowed Liquidia to rely on solution values disclosed by the experts to calculate the dosage range and eventually knock out the claims. Thus, Liquidia stands as a good reminder of the important role that expert testimony can play in supporting a party's case during IPR proceedings.
Footnotes
1 IPR2022-00677, Paper 7 (P.T.A.B. August 24, 2022).
2 The remaining grounds were directed to the alleged unpatentability of certain dependent claims, and are not discussed in this article.
3 Genetics Instit., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1306 (Fed. Cir. 2011)
4 IPR2021-00406, Paper 78 (P.T.A.B. July 19, 2022).
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