Patent Law Practice Center

Hatch files Amendment to Fix IPRs for Pharma

Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter partes review (IPR) filings relating to brand name pharmaceuticals. According to Senator Hatch, his amendment is intended to fix IPRs and restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development. The Hatch-Waxman Act encourages generic drug manufacturers to challenge patents of brand name drugs by filing Abbreviated New Drug Applications with the Food and Drug Administration, which can and typically does result in patent infringement litigation in federal district court.

“As the coauthor and namesake of Hatch-Waxman, I have a keen interest in ensuring we have a well-functioning generic drug industry,” said Senator Hatch in a press release published last night. “My amendment will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”

In recent years inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has created an alternative path to challenge the patents of brand name drugs; a path alternative to the path envisioned in Hatch-Waxman. Those who support the Hatch-Waxman regime view IPRs as upending the careful Hatch-Waxman balance.

Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process. Parties would not be able to use both. In this way, the amendment aims to fix the misuse of IPRs by generics as parallel and duplicate proceedings to disputes already in place under Hatch-Waxman.

Politically, this Hatch “pick a path“ amendment is going to be paired with S. 974, The CREATES Act of 2017 (H.R. 2212).  This legislation aims to enable the sharing of samples so that generics can compete more effectively.  You can learn more about the substance of the CREATES Act by reading Senator Leahy’s summary here. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enjoys broad, bipartisan support from Senators Leahy, Grassley, Feinstein, Graham, Durbin, Lee, Whitehouse, Cruz, Klobuchar, Kennedy, and Blumenthal.  Generics want the CREATES Act, and there are 28 co-sponsors.  The bill was voted out of the Judiciary Committee favorably, but Hatch voted against it.

Raising and connecting the Hatch-Waxman IPR fix to the CREATES Act balances two major interests of both the brand and generic industries.  Brand needs this Hatch-Waxman IPR fix and generics want CREATES.  Like Hatch’s original objective with Hatch-Waxman, each side gains something…resolving a major problem for them…and neither loses anything that they had any reasonable expectation that they would, or should, be able to maintain.

Eli Lilly cancer treatment upheld by PTAB

Several weeks ago, a final written decision issued by the Patent Trial and Appeal Board (PTAB) upheld a series of 22 claims from a patent owned by Indianapolis-based drugmaker Eli Lilly & Company. This decision ends an inter partes review (IPR), which was initially petitioned by Chicago-based generic pharmaceutical firm Neptune Generics to challenge a patent covering Alimta, a drug approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with advanced nonsquamous non-small cell lung cancer (NSCLC).

The Eli Lilly patent challenged by Neptune in the IPR was U.S. Patent No. 7772209, titled Antifolate Combination Therapies. Issued in August 2010, it covers a method for administering pemetrexed disodium to a patient in need thereof by administering effective amounts of folic acid and a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium; the particular methylmalonic acid lowering agent used by the treatment is vitamin B12. The use of vitamin B12 in the treatment helps to reduce the cytotoxic activity which antifolates can create in a patient’s body when that patient is undergoing chemotherapy, helping to limit the potentially life-threatening toxicity which antifolates can cause in the human body.

(more…)

Drug patents fare better at PTAB

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners in general, the PTAB has not been inhospitable to pharma patent owners according to a report issued by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges at the PTAB. The report looks at a combination of data sources, including the Orange Book, Center for Drug Evaluation and Research (CDER) listed biologics and statistics on America Invents Act (AIA) trials published by the PTAB. The BiologicsHQ report draws the conclusion that, despite widespread concerns about the PTAB operating as a patent death squad in IPRs, “such concern is not justified for drug patents.”

According to the March 2017 IPR statistics issued by the PTAB, 53 percent of IPRs resolved as of March 31, 2017 were instituted; the rest were either denied institution or reached some other resolution prior to the institution decision. 35 percent of all resolved IPRs resulted in final written decisions and 23 percent led to findings of all claims unpatentable. Only 7 percent of all resolved IPRs led to final written decisions finding that no claim was unpatentable, and 5 percent led to mixed claim findings.

By contrast, drug patents fare better under PTAB scrutiny in terms of having claims upheld. Of the 4,563 resolved IPRs, BiologicsHQ reports that 222 petitions (5 percent) involved patents covering drugs listed in the Orange Book. Focusing on just the IPRs involving Orange Book patents, 44 percent were instituted and 38 percent reached a final written decision, but only 16 percent led to final written decisions where all claims were found unpatentable. No instituted claim was found unpatentable in 50 percent of final written decisions (19 percent of the total number of resolved Orange Book IPRs).

CDER-listed biologic drug patents also survive PTAB challenges better than patents not directed to pharmaceutical drugs, although the number of resolved challenges is quite small by comparison. By March 31, 2017, BiologicsHQ reports that a total of 29 resolved IPR petitions involved patents covering CDER-listed biologics. 41 percent of those petitions were instituted and 28 percent reached final written decisions. 17 percent of all resolved CDER-listed biologic drug IPRs led to final written decisions of all claims unpatentable, and 10 percent led to final written decisions of no claims unpatentable.

When comparing final written decisions among all IPRs, IPRs relating to Orange Book patents, and IPRs relating to CDER-listed biologic drug patents, Orange Book and CDER-listed biologic drug patents are more likely to escape with all claims intact. For all resolved IPRs, 23 percent led to final written decisions of all claims unpatentable. That’s a higher percentage than the 16 percent of Orange Book IPRs, and 17 percent of CDER-listed biologic drug IPRs that led to final written decisions where all claims are unpatentable. The 7 percent of all IPRs that led to final written decisions of no claims unpatentable is less than the 10 percent of CDER-listed biologic drug IPRs, and the 19 percent of Orange Book IPRs, that met the same fate.

Overall, 58 percent of IPRs involving drug patents resolved by the PTAB resulted in some claims remaining patentable: 60 percent for Orange Book IPRs and 45 percent for CDER-listed biologic IPRs.

Eli Lilly, Pfizer among those supporting Sequenom cert petition

Recently, a group of amici led by Eli Lilly filed an amici curiae brief with the United States Supreme Court in the matter of Sequenom, Inc. v. Ariosa Diagnostics, Inc. The Eli Lilly brief was filed in support of the petitioner, Sequenom. Eli Lilly is joined in this brief by Eisai Inc., Upsher-Smith Laboratories, Inc., Pfizer Inc., and Etiometry, Inc.

On March, 21, 2016, Sequenom filed a Petition for Writ of Certiorari in the Supreme Court, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. If the Supreme Court takes this case, they will be asked to reconsider the unfortunate breadth of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. See SCOTUS Blog Founder asks Supreme Court to Reconsider Mayo.

(more…)

FTC charges Endo Pharmaceuticals with “pay for delay” antitrust violation

On March 30, 2016, the Federal Trade Commission filed a complaint in the United States Federal District Court for the Eastern District of Pennsylvania alleging that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using “pay for delay” agreements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm. The complaint also names Allergan plc, the parent company of Watson, and Endo International plc, the parent company of Endo Pharmaceuticals Inc. According to the FTC, this enforcement action is the first FTC case challenging an agreement not to market an authorized generic – often called a “no-AG commitment” – a form of reverse payment. A no-AG (“no authorized generic”) commitment involves a branded firm agreeing that it will not launch its own generic alternative when the first generic begins to compete. Because introduction of an authorized generic from the branded company would cut into the revenues of a competing generic, a no-AG commitment can induce the generic company to delay its entry.

This enforcement action by the FTC comes thanks to a June 2013 ruling from the United States Supreme Court in FTC v. Actavis, Inc.  In a nutshell, writing for the majority, Justice Breyer explained that there is no valid reason for the FTC to be denied the opportunity to pursue reverse payments as an antitrust violation.  Breyer (joined by Justices Kennedy, Ginsberg, Kagan, and Sotomayor) determined that reviewing courts should apply the rule of reason when determining whether reverse payments violate antitrust law. See Supremes Say Reverse Payments May be an Antitrust Violation. Prior to the ruling in FTC v. Actavis, it was widely believed that the FTC did not have authority to challenge reverse payments as settlements of patent disputes. See Pharma Reverse Payments Are Not an Antitrust Violation.

(more…)