Recent Developments in Pharma and Biologics IP Law:

A Discussion of Recent Cases Affecting Pharma and Biologics IP Law

Topic 1: Cases Interpreting the Biologics Price Competition and Innovation Act (BPCIA)

BPCIA – The Patent Dance

  • Purple Book does not list patents. Instead, Biosimilars Act contemplates an initial exchange of information prior to potential patent litigation:
    1. Within 20 days of notice of FDA acceptance, a biosimilar applicant “shall” provide a copy of its aBLA and information describing the manufacturing process.
    2. Within 60 days later, the reference product sponsor “shall” provide a list of patents and identify patents it will license. • Within 60 days later, the biosimilar applicant “shall” provide detailed statement of defenses, or assert that it does not intend to commercially market before patent expiration.
    3. Within 60 days later, the reference product sponsor “shall” provide its own detailed statement.
  • Based on the exchanges outlined on the previous slide, the parties then proceed to identify a set of patents for the first stage of litigation.
  • The parties “shall” negotiate in good faith to identify the patents that will be the subject of an immediate action for patent infringement.
  • If the parties agree at this stage, the reference sponsor “shall” bring suit on those patents within 30 days. Otherwise, the “sole and exclusive remedy” for an untimely suit is a reasonable royalty.
  • On the other hand, when a biosimilar applicant fails the disclosure requirement, the only remedies as those being based on a claim of patent infringement.

BPCIA – Patent Litigation

  • Biosimilar applicant must provide notice to the reference product sponsor of its intent to commercially market the proposed biosimilar product.
    1. Must provide this notice not later than 180 days before the date of the first commercial marketing.
    2. Upon receiving this notice, the reference product sponsor may seek a preliminary injunction on any patents that it identified during its information exchanges with the applicant.

Two Cases Focused the Issues for the Supreme Court

Summary of Amgen v. Sandoz & Amgen v. Apotex

  • The CAFC held that:
    1. Biosimilar makers may opt out of providing the aBLA and other manufacturing information (i.e., “patent dance” is optional). Innovator company could sue and “access the required information through discovery.”
    2. The 180 days’ post-licensure notice is mandatory regardless as to participation in the patent dance. The 180 days’ postlicensure notice begins to run only after the FDA licenses the product.
  • Both Amgen v. Sandoz and Amgen v. Apotex were appealed to the U.S. Supreme Court.
  • Supreme Court recently heard oral argument.
  • The opinion of the Supreme Court is expected next month.

Detailed Analysis of Disclosure Requirements

Amgen v. Sandoz

  • Sandoz disclosed electronic versions of its aBLA and information relating to manufacturing.
  • Amgen provided a list of patents.
  • On February 2, 2016, Sandoz wrote to Amgen that it agreed on the patents and that it believed the remaining steps of the patent dance were complete.
  • Sandoz’s position was that the remaining steps were already carried out in related litigation between these parties in the Northern District of California regarding a related biosimilar product.
  • 30 days later, Amgen filed suit in the District of New Jersey, seeking to compel Sandoz to finish the patent dance. Shortly after the suit was filed, Sandoz wrote to Amgen, offering to finish the patent dance.
  • Amgen agreed to proceed with the remaining steps, which were completed on April 12, 2016.
  • 30 days later, Amgen filed suit in the Norther District of California for patent infringement.
  • The District of New Jersey found the disclosures to be compliant and dismissed Amgen’s complaint seeking to compel Sandoz to finish the dance.

Amgen v. Hospira

  • Hospira provided Amgen with its aBLA, which included over 507 native files and almost 1 million pages of additional information regarding the product and process used.
  • Amgen found the disclosure insufficient to evaluate infringement of its process patents.
  • Amgen thus sued Hospira in district court for patent infringement on the product patents and requested the manufacturing information during discovery.
  • Hospira argued that the requested information was not relevant to any of the patents currently at issue in the litigation.
  • Hospira also pointed out that Amgen never identified a single relevant process patent, claiming that Amgen was simply going on a “fishing expedition” to identify potentially infringed patents.
  • Hospira argued that Amgen is barred from suing on its manufacturing patents (and therefore from obtaining the discovery relevant to those patents) because it did not list them during the “patent dance.”
  • Amgen argued that the innovator company is only required to provide a list of patents, including manufacturing patents, after the biosimilar applicant provides both its biosimilar regulatory application and the manufacturing information, which Hospira did not do.
  • Amgen also argued that it could not know which patents “could reasonably be asserted” and therefore listed without first obtaining Hospira’s manufacturing information.
  • The district court denied Amgen’s motion to compel, and Amgen filed a timely appeal to the Federal Circuit.
  • On appeal, Amgen argues that both available paths, the disclosure requirements of the BPCIA during the patent dance and discovery in a patent infringement case, have been closed off.
  • Hospira moved to dismiss the appeal for lack of jurisdiction on the ground that district court has not yet issued a final judgment in the case.
  • The CAFC determined to allow the appeal to proceed on the merits while at the same time requiring the parties to further address jurisdictional issues.
  • Oral argument took place on April 3, 2017.
  • Amgen argued that under Amgen v. Sandoz, it is allowed discovery with regard to potential infringement of any patent. According to Amgen, the scope of discovery is dependent on the aBLA product, not the asserted patents.
  • Hospira argued that the BPCIA does not trump Rule 26’s strictures on the scope of discovery, and because Amgen did not assert manufacturing process patents, it is not entitled to discovery of Hospira’s manufacturing information.
  • It remains to be seen how the CAFC will rule.

Janssen v. Celltrion

  • Celltrion provided Janssen with its entire aBLA but refused to disclose information relevant to manufacturing
  • Celltrion asserted that Janssen could adequately prepare its list of patents without the manufacturing information and that such information would be disclosed in discovery.
  • Janssen filed suit for patent infringement of product and method of manufacturing patents, among others.
  • Janssen also seeks declaratory relief that Celltrion did not comply with the patent dance.
  • The case is pending in the District of Massachusetts.

Immunex v. Sandoz

  • Sandoz provided Immunex with remote access to a Sandoz-hosted database, modified to include added confidentiality designations.
  • Sandoz represented the files constitute its aBLA and manufacturing information.
  • Immunex argued that the disclosure was not sufficient, unduly burdensome, and in an altered state. Nevertheless, Immunex sued for patent infringement of product and method of manufacturing patents, among others.
  • The case is pending in the District of New Jersey

Genentech v. Amgen

  • When FDA accepted Amgen’s aBLA, Amgen provided Genentech with the aBLA, but refused to provide its manufacturing information.
  • Genentech filed a declaratory judgment action, arguing that this partial disclosure violated the BPCIA’s patent dance.
  • Amgen moved to dismiss, arguing that the Federal Circuit found that the patent dance is optional in Amgen v. Sandoz.
  • Genentech sought to distinguish Amgen v. Sandoz, noting that Sandoz opted out entirely, where as Amgen here is purporting to opt in.
  • The District Court dismissed Genentech’s complaint.
  • The Court held that the only remedy for noncompliance with the patent dance is patent infringement lawsuit, as opposed to the declaratory judgment action brought by Genentech.

Janssen v. Pfizer

  • BPCIA requires that once the parties agree on the first wave of patents, the reference sponsor “shall” bring suit on those patents within 30 days. Otherwise, the “sole and exclusive remedy” for an untimely suit is a reasonable royalty.
  • When FDA accepted Pfizer’s aBLA, Pfizer provided Janssen with the aBLA and manufacturing information.
  • After Janssen provided the list of patents, Pfizer refused to proceed with the other steps, stating that it agreed to Janssen’s list of patents.
  • Janssen sued Pfizer for patent infringement and also argued that Pfizer’s refusal to finish the dance did not trigger the 30-day window within which to file suit.
  • Pfizer moved to dismiss the lawsuit because Janssen failed to name appropriate parties as the complainants.
  • Issue: If Janssen has to re-file the suit, will it be outside of the 30-day window and therefore only be entitled to a reasonable royalty?
  • The district court held that biosimilar makers must satisfy each step of the BPCIA dance if they hope to reduce damages that innovator companies can seek for infringement.
  • Biosimilar makers must engage in the patent dance’s entire proceedings, including alternative dispute proceedings, in order to trigger the 30-day window.


Summary of Cases

Amgen v. Sandoz re: Neupogen® (filgrastim): Pending at the Supreme Court (No dance)

Amgen v. Sandoz re: Neulasta® (pegfilgrastim): Consolidated with filgrastim case for discovery and trial. (Danced)

Amgen v. Apotex re: Neulasta® (pegfilgrastim) and Neupogen®(filgrastim): Pending at the Supreme Court (Danced)

Amgen v. Hospira re: Epogen®/ Procrit® (epoetin alfa): Pending at the CAFC (Some dance)

Janssen v. Celltrion re: Remicade® (infliximab): Pending jury trial. (Some dance)

Immunex Corp. v. Sandoz Inc. re: Enbrel® (etanercept): Pending at the district court. (Some dance)

Genentech v. Amgen re: Avastin® (bevacizumab): Case dismissed (Some dance)

Janssen v. Pfizer re: Remicade® (infliximab): Pending at the district court (Some dance)

TOPIC 2: Recent CAFC Pharma Cases

Helsinn Healthcare v. Teva Pharmaceuticals

  •  Overview of the “on-sale bar:”
    • In U.S. patent law, the on-sale bar is a limitation on patentability. It provides that an invention cannot be patented if it has been for sale for over one year prior to the patent filing.
  • Issue – whether a publicly-announced “Supply and Purchase” agreement triggers the on-sale bar.

The “Public” Announcements At Issue

  • Two years before applying for the patents, Helsinn and a third party company (MGI) entered into a Supply and Purchase Agreement relating to the products that subsequently were patented.
  • The agreement was announced in a joint press release and was filed with the Security Exchange Commission (SEC).
  • However, the announcements did not publicly disclose key portions of the agreement, such as the specific dosage formulations covered by the agreements (i.e., the 0.25 and 0.75 mg doses).
  • Thus, the announcements did not disclose every aspect of the claims that were subsequently filed.
  • The CAFC held that the announcements of the Supply and Purchase Agreement triggered the on-sale bar:
    • Where the existence of the sale was made known to the public, the sale constitutes prior art even if the public disclosure did not reveal the invention.
    • Even though specific details of the Helsinn invention were not made public by the announcement, the existence of the invention was made public, which triggered the on-sale bar.


Novartis v. Noven Pharmaceuticals

Novartis sued several generic companies for infringement:

    • The first company Novaris sued, Mylan, argued in District Court that the claims were invalid.
    • The District Court found the claims to be valid.
    • On appeal to the CAFC, the CAFC affirmed this validity finding.
    • Novartis then sued Noven on the same claims that the CAFC found valid in the Mylan case.
    • Noven filed an IPR proceeding, seeking to invalidate the asserted claims.
    • The PTO found the claims to be invalid and unpatentable.
  • Novartis appealed the PTO’s invalidity finding to the CAFC.
  • On appeal, Novartis argued that the PTAB decisions were legally improper in view of the prior court decisions upholding the patents.
  • The CAFC agreed with Noven and affirmed the PTO decisions invalidating the claims.
  • The CAFC found that:
    • The evidence at issue in the two cases was different such that a different result should be possible; and
    • Even if the evidence were found to be the same, the standards are different:
    • The district court determines unpatentability by clear and convincing evidence
    • The PTO, in most cases, determines unpatentability by a preponderance of the evidence.
  • Thus, the PTAB properly may reach a different conclusion based on the same evidence.

The Medicines Co. v. Mylan

  • At issue were a compound patent and a method patent. Both patents included claims that required “pharmaceutical batches” and “wherein the batches have a maximum impurity level [] that does not exceed about 0.6%.”
  • Regarding the compound patent, none of its claims used product-byprocess language or recited method step.
  • The claims of the method patent further required “efficiently mixing” a pH-adjusting solution with the first solution to form a second solution.
  • The issue was the definition of “pharmaceutical batches”.
  • The Federal Circuit characterized the invention at issue as addressing the problem of batch variability.
  • The Medicines argued that the claims do not require the use of a particular process that achieves batch consistency. The Federal Circuit rejected this argument.
  • The Federal Circuit held that the specification and prosecution history of the patents demonstrate that the invention is a compounding process that achieves batch consistency.
  • The Court also noted that Medicines admitted to the district court that ‘[w]hen viewed in the context of the specification, it is readily apparent that the [definition of “pharmaceutical batches”] refers to the compounding processes described in the patents-in-suit.”
  • The Court also noted that the patents state that “‘the [efficient mixing] process demonstrated in Example 5 produced batches generally and consistently having lower levels of impurities than the [inefficient mixing] process of Example 4
  • The Federal Circuit concluded that “the batches limitation requires the use of a compounding process that achieves batch consistency.”
  • The Federal Circuit determined that the batch consistency requirement is defined by the mixing of Example 5:

Example 5 . . . is not merely the only disclosed embodiment of efficient mixing—it is the only description of efficient mixing in the patents in suit that casts light on what efficient mixing is and that enables one of ordinary skill in the art to achieve the objects of the claimed invention.

  • Federal Circuit construed the composition claims and method claims as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the examples, specifically, Example 5.
  • While doing so, the Federal Circuit preserved the validity of the patents. However, it required reversal of the district court’s infringement ruling.

TC Heartland v. Kraft Foods Group

  • On Monday, May 22, 2017, the Supreme Court issued its decision in TC Heartland v. Kraft Foods Group.
  • ISSUE: Forum Shopping.
  • According to U.S. Senator Hatch: “Abusive litigants have exploited a hole in the law to direct a disproportionate number of suits to plaintiff-friendly forums, and to one such forum in particular.”

Popular Patent Litigation Venues

TC Heartland: Background

  • The federal law governing patent venue states that a patent lawsuit may be filed where the defendant “resides” or “committed acts of infringement and has a regular and established place of business.”
  • In 1957, the Supreme Court decided that “resides” meant the place of incorporation.
  • The Federal Circuit in 1990 adopted a more broad interpretation that allowed patent lawsuits to be filed anywhere that a defendant does business.
  • TC Heartland argued on appeal to the Supreme Court that CAFC’s broad interpretation was erroneous.
  • The Supreme Court agreed, holding that a domestic corporation “resides” only in its state of incorporation for purposes of the patent venue statute.

TC Heartland: Implications

  • The Supreme Court put tighter restrictions on where patent owners can file infringement lawsuits. The decision will impact forum shopping.
  • For most patent owners, venue choices will be limited to the accused corporation’s principal place of business or its state of incorporation. The Eastern District of Texas will likely see a dramatic reduction in its number of patent infringement cases.
  • Many are predicting that the Supreme Court’s ruling will shift a large portion of patent cases would shift to Delaware, where many companies are incorporated, and the Northern District of California, which is home to many technology companies.
  • New patent cases: In newly filed patent cases, venue will only be proper where a U.S. corporation is actually incorporated or where the corporation has committed acts of infringement and “has a regular and established place of business.”
  • What a regular and established place of business is not well defined.
  • Most likely, the corporation will need to really have offices, people, equipment etc. in the district for venue to attach.
  • Previously filed case: Rule 12(b)(4) allows a defendant to seek dismissal for improper venue. The defense is waived, however, if a motion challenging venue is not filed or in a responsive pleading or, in some circumstances, where the defendant meaningfully participates in the action.
  • Foreign Companies: Under current law, suits against foreign companies can be brought in any district. For the past nearly 30 years this has not been a big issue because patent infringement suits against most defendants could be brought in a large number of venues.
  • It remains unclear whether or how TC Heartland may affect venue for foreign companies doing business in the US.
  • In a footnote the Court said that it specifically was not addressing the venue determination for a foreign corporation and that it was not expressing any opinion on the Court’s holding in Brunette Machine Works, Ltd. v. Kockum Industries, Inc., 406 U.S. 706 (1972) (determining proper venue for foreign corporation under then existing statutory regime).

Download the entire presentation here: Recent cases affecting pharma and biologics