By: Katie Rubino
On December 12th, 2018 the U.S. Patent and Trademark Appeal Board (PTAB) came to an agreement in an inter partes review (IPR) proceedings. The proceeding focused on claims brought by Mylan against two patents, U.S. Patent Nos. 7,476,652 and 7,713,930 owned by Sanofi for Lantus (insulin glargine injection) 100 Units/mL. Lantus is a long acting basal insulin used by both Type 1 and Type 2 diabetics to control their blood sugar and Hemoglobin A1C.
Ways to challenge patents were recently modified by the Leahy-Smith America Invents Act (AIA) of 2011, which allows for options in challenging the validity of a competitors’ patents while avoiding the significant cost of litigation. Challenges before the PTAB include post grant review (PGR), IPR and covered business method review (CBM; available only to patents directed to covered business methods).
PGR allows for a patent to be challenged on any ground of invalidity that could otherwise be asserted as a defense in patent litigation. For example, PGR allows a patent to be challenged under ⸹101 patentable subject matter, ⸹102 novelty, ⸹103 obviousness, and ⸹112 indefiniteness. While PGR allows for a broad scope of challengeable subject matter, such a challenge must be brought within nine months after a patent has been issued. PGR can be filed by a person who is not the patent owner and who has not previously filed a civil action challenging the validity of a claim of the patent. The challenger must provide sufficient evidence to demonstrate that it is more likely than not that at least one claim is unpatentable. The basis of the challenge is not limited to patents and printed publications, but can allow for any form of prior art. A final decision made in a PGR is appealable to the Federal Circuit.
IPR proceedings are utilized to review the patentability of one or more claims in a patent based on ⸹102 and ⸹103 challenges, including novelty and obviousness. IPR is more limited in that only patents or printed publications may be utilized to demonstrate that at least one claim is unpatentable. IPR may not be filed until the later of nine months after a patent has been issued or after a PGR proceeding has terminated. IPR can be initiated by a person who is not the patent owner and has not previously filed a civil action challenging the validity of a claim of the patent. The PTAB may grant an IPR petition when there is a reasonable likelihood that the petitioner will prevail as to at least one challenged claim. A final decision made in an IPR is appealable to the Federal Circuit.
| Proceeding | Time to File | Who Can Initiate | Basis for Challenge | Standard of Proof | Ability to Appeal to Federal Circuit |
|---|---|---|---|---|---|
| Post-Grant Review | Up to 9 months after issuance of patent | Any person who is not the patent owner | 101, 102, 103, and 112 | More likely than not | Yes can appeal decision to Federal Circuit |
| Inter-Partes Review | Later of 9 months after issuance of patent or date of termination of post-grant review | Any person who is not the patent owner | 102, 103 (patents and printed publications only) | Reasonable likelihood that petitioner will prevail | Yes can appeal decision to Federal Circuit |
A review of petitions filed at the United States Patent and Trademark Office (USPTO) indicates that since September 16th, 2012 when PGR and IPR’s were enacted by the AIA, 9,522 petitions have been filed. Of those, 8,803 or 92% have been filed for IPR. 147 or 2% have been filed for PGR and 572 or 6% have been filed for covered business method patents. Over the past 12 months, the number of IPR’s filed have continued to increase, with 115 filed in October 2018 and 212 filed in November 2018. From September 16th, 2012 to November 30th, 2018, 730 proceedings were filed pertaining to bio/pharma art units. Of those 730 filed, 435 or 60% were initiated by the PTAB and allowed to proceed to trial.
| Petition Type | # Petitions Filed Since AIA | % of Petitions Filed Since AIA |
|---|---|---|
| IPR | 8,803 | 92% |
| PGR | 147 | 2% |
| CBM | 572 | 6% |
Source: USPTO (# of petitions filed since enactment of AIA)
In the present IPR petition, the PTAB announced that IPR proceedings would be instituted and proceed to trial on the two applicable patents on December 14th, 2017, after Mylan first initiated two IPR proceedings on June 9th, 2017.
In regards to U.S. Patent No. 7,476,652 the claims were directed to the combination of insulin glargine with at least one surfactant selected from polysorbates and poloxamers in an acidic formulation. The PTAB found all claims of the ‘652 patent to be unpatentable based on six different grounds of invalidity.
In regards to U.S. Patent No. 7,713,930 the claims were directed to the combination of insulin glargine with at least one surfactant selected from esters and ethers of polyhydric alcohols in an acidic formulation. The PTAB found all claims of the ‘930 patent to be unpatentable based on eight different grounds of invalidity.
One such rationale for the PTAB’s invalidation of both patents had to do with obviousness. The PTAB found that insulin glargine was widely known in the prior art, even based on some of Sanofi’s own earlier formulations of insulin glargine. Furthermore, combining insulin glargine in combination with a surfactant had been previously taught in the prior art. The PTAB also found that because both the ‘652 and ‘930 patents explained that insulins had a known tendency to aggregate in the presence of hydrophobic substances, that a person of ordinary skill in the art would have had a reasonable expectation of success in adding a surfactant in combination with insulin glargine.
Further, prior art had taught many examples of stabilization of insulin glargine and other peptides using surfactants. During the IPR proceeding, Sanofi argued that molecules such as peptides and protein molecules are unpredictable and thus picking a surfactant to assist in stabilization is nonobvious. However, the PTAB dismissed Sanofi’s arguments with respect to nonobviousness.
In addition, Sanofi pointed to the commercial success of its insulin glargine products as further evidence of nonobviousness. By 2017, U.S. sales of Sanofi’s inulin glargine products were valued at approximately $2.6 billion, accounting for approximately 1/3 of all sales of long acting insulin therapies in the U.S. The PTAB dismissed these arguments, finding that Sanofi’s commercial success was of minimal probative value. Further, Sanofi failed to investigate other patents that embraced “the same technologies.” The PTAB found that Sanofi could have minimized of these obviousness type rejections by having entered into licensing agreements with other companies engaging in similar technologies.
Looking ahead, it appears that Sanofi has another uphill battle, as Mylan has filed ten additional IPR’s related to five of Sanofi’s pen type insulin glargine patents. These additional IPR’s were filed by Mylan on September 10th, 2018 and as of now, the PTAB has not yet granted a decision as to whether these proceedings will be initiated and proceed to trial. Should these additional IPR proceedings move forward, it will be interesting to see what arguments Sanofi may use to try to overcome the obviousness arguments previously presented.