Creative Strategies of Attack
| February 19, 2019
Mylan Pharmaceuticals Inc., Breckenridge Pharmaceutical, Inc., Alembic Pharmaceuticals Ltd., v. Research Corporation Technologies, Inc.
February 1, 2019
Before Lourie, Bryson, and Wallach. Opinion by Lourie.
Summary
Creative strategies of attack can be made on a patent even when the challenger is apparently precluded by statute. In particular, this decision highlights that parties who would have been time barred in filing an inter partes review (IPR) petition, in this case, Mylan Pharmaceuticals, Breckenridge Pharmaceutical and Alembic Pharmaceuticals, can be joined in an IPR and then appeal an adverse decision, even though the original petitioner (Argentum) would lack Article III standing for an appeal in federal courts.
On the merits, this decision reiterates that all facts need to be considered in making a final obviousness determination, including establishing a motivation to modify a compound.
Background
The appellants (Mylan, Breckenridge and Alembic) appeal the final decision of the Patent Trial and Appeal Board (PTAB) in an IPR concluding that claims 1-13 of Reissue 38,551 are not unpatentable. The IPR was based on a petition filed by Argentum Pharmaceuticals who is not an appellant in the appeal. Upon institution of the IPR, the appellants (Mylan, Breckenridge and Alembic) filed their own petitions with concurrent motions for joinder. Each of these appellants had been sued for infringement of the ‘551 reissue in 2013, more than a year before the petitions were filed. Note that 35 USC 315(b) states:
An inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent. The time limitation set forth in the preceding sentence shall not apply to a request for joinder under subsection (c).(Emphasis added)
The PTAB permitted joinder. Subsequently, the PTAB rendered its decision on the merits concluding that each challenged claim had not been shown to be unpatentable. Mylan, Breckenridge and Alembic appealed the decision. Argentum, on the other hand, did not join the appeal as Argentum lacked standing under Article III of the Constitution (Argentum did not have any injury and therefore lacked entry into the federal appellate court system).
Discussion
Standing
RCT argues that the appellants lack standing because RCT had brought an infringement action against each appellant more than a year before the IPR petitions were filed. RTC argues that although the appellants were permitted to join, the initial petitioner’s IPR (filed by Argentum) was limited to an agency matter, and therefore there would be no Article III standing. The appellants, on the other hand, point out that they have an express, statutory right to appeal. The CAFC agreed. To reach this conclusion, the CAFC looked to the text of 35 USC 315(c) stating that a party may be joined. Then section 319 provides that “a party” may appeal.
Merits
The PTAB had accepted a certain compound (identified as compound 3l) as a lead compound, and concluded that the petitioners failed to establish motivation to modify that compound. The CAFC agreed that the appellants had failed to meet their burden to establish a motivation to modify. From the decision, it does seem like the arguments of obviousness were a stretch.
In this regard, the appellants first focused on a methoxyamino group in compound 3l as being uncommon and having potential synthetic and stability problems as a basis for a POSITA to have been motivated to modify in a certain way, and that the proposed modified compound would have been expected to have excellent potency.
The evidence presented by RCT, however, showed that compound 3l was actually stable and that the record was devoid of evidence of potential stability issues. In addition, RCT argued that the appellants did not provide any evidence that “only methylene would result in a more pharmaceutically common and acceptable compound and resolve the potential stability and synthesis concerns presented by the methoxyamino moiety.”
In conclusion, the CAFC concluded that the PTAB had appropriately considered all facts before making a final obviousness determination.
Although not in the decision, an examination of the history of the patent in suit is interesting. First, it is always interesting when a reissue is involved. Reissue is used to correct errors in a patent when the patent is considered defective or inoperative. The original patent issued as USP 5,773,475 on June 30, 1998. The reissue application was filed on the basis that the original patent was inoperative because priority to a provisional application was not perfected. This step was taken apparently due to some ambiguity when the American Inventors Protection Act of 1999 was enacted. This became an issue because the non-provisional application was filed a little over one year from the provisional filing date because the one year anniversary fell on a Saturday. The non-provisional application was filed on the succeeding Monday. 35 USC 119(e) (3) was amended to clarify that if the anniversary date fell on a Saturday, Sunday or Federal holiday, the filing on the next succeeding business day would be considered timely.
In addition, it is interesting to note that an ex parte reexamination was filed on April 9, 2018 as another attack on the reissue patent. The ex parte reexamination resulted in cancellation of claims 1-7, confirmation of patentability of claims 8-13, and a determination that newly added claims 14-28 are patentable. The same rejections appear to have been addressed in the ex parte reexamination as in the IPR proceeding. Note that the IPR was filed November 25, 2015, and then the ex parte reexamination was filed April 29, 2016. The PTAB had issued an order staying the ex parte reexamination proceeding until the PTAB had issued its final written decision in the IPR.
The reissue patent was also granted 5 years of patent term extension. The reissue patent covers the drug lacosamide which is used to treat epilepsy.
Takeaway
Creativity and knowledge of the laws can open the way to challenge patents even when it does not seem possible.
