Posts Tagged: "biosimilars"

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably determine which of its patents might be infringed by the biosimilar. Now, potentially meritorious patent infringement questions could be kicked far down the road. This could lead to delayed launch of the biosimilar product, possibly through a decision not to launch at risk or possibly by way of injunctive relief outside the BPCIA.

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, providing twelve years of market exclusivity to pioneer biologics… Like the Hatch-Waxman Act, the BPCIA also sets out a process for identifying disputes over patent infringement and managing any ensuing litigation once an applicant seeks a biosimilar license… To streamline the first wave of litigation, the BPCIA mandates that following the biosimilar applicant’s receipt of the RPS’s detailed statement on infringement, the parties negotiate in good faith to select patents for litigation from the lists initially provided by the RPS and the biosimilar applicant. [§ 262(l)(4)].

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal Circuit concluded that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015). Where an aBLA filer elects to forego the patent dance by failing to provide the aBLA and the biosimilar manufacturing information to the RPS, the only remedy available to the RPS lies in a declaratory judgment action for patent infringement, as expressly contemplated by § 262(1)(9)(C). In addition, the court concluded that an aBLA filer who did not engage in the patent dance was required to provide a notice of commercial marketing and that such notice could be effectively given only after the FDA had approved the aBLA. The court’s ruling left open the question whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. This decision is on appeal to the Supreme Court, which has yet to decide whether it will hear the issue.

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would extend the 12-year exclusivity period given to a sponsor by 180 days (six additional months). Even when market entry is delayed under (8)(A) by 12 years plus 180 days, the result is the same, because the 12-year date is established as the earliest date, not the latest date, on which a biosimilar license can take effect. The Court affirmed that section (8)(A) covers applicants that filed (2)(A) notices as well as those that did not. This is to ensure that the necessary decision-making regarding further patent litigation starts from when the applicant’s product, uses, and processes are fixed by the FDA license. The 180-day period gives the sponsor essential time to assess its infringement position for the final FDA approved product and the as to yet-to-be-litigated patents. This is confirmed by the legislative history of the Biologics Act. Thus, an applicant must provide a reference product sponsor with the 180-day notice under 8(A), after approval and before commercial marketing begins, whether or not the applicant previously provided a (2)(A) notice of the FDA review.

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement knocks that term down to 5 years. Sources have confirmed to me that a TPP deal that so substantially reduced biologic data exclusivity will face an uphill battle in Congress.

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.

This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during drug approval. However, because of the differences between these two types of drugs, stemming from the increased complexity in manufacturing and patent protection, unique provisions were included in the BPCIA. Unfortunately, as Judge Lourie of the Federal Circuit put it, the BPCIA could win a “Pulitzer prize for complexity or uncertainty.” And, it is these new provisions that could prove the downfall of the BPCIA, at least as it currently exists.