I-MAK's U.S. Cases
on Sofosbuvir

I-MAK filed the first-ever U.S. patent challenges against sofosbuvir, the backbone of Sovaldi®, Harvoni®, and Epclusa®, arguing that the drug’s core patents do not meet the legal standards for novelty and non-obviousness. If Gilead’s eight patents are overturned, U.S. taxpayers will save more than $10 billion and generics will come to market 16 years earlier.

Summary of Patents Challenged

Patent Number: 7,429,572

Patent Type: Base
Family: Clark
Expiry: 4/3/2025
Summary: Sofosbuvir is the backbone of all Gilead’s hepatitis C treatments. The core molecule in sofosbuvir is a nucleoside compound. Years before Gilead filed its patents, nucleosides like sofosbuvir already existed in relation to antiviral and anticancer treatments. The core molecule in sofosbuvir has all the same elements in the same arrangement as these existing nucleosides except for one element that is an obvious change.
Grounds: Anticipation and Obviousness
Petitions: 1

Patent Number: 7,964,580

Patent Type: Prodrug
Family: Sofia
Expiry: 03/26/2029 (4 years past base patent expiry)
Summary: A prodrug helps humans metabolize an inactive drug base compound once it enters the body. This type of prodrug has accompanied nucleoside treatments for decades. Since sofosbuvir is a nucleoside, using this type of prodrug was an obvious choice to activate the basic molecule. Gilead’s two main prodrug patents extend its monopoly by four years to 2029.
Grounds: Anticipation and Obviousness
Petitions: 1 | 2

Patent Number: 8,735,372

Patent Type: Prodrug
Family: Sofia
Expiry: 03/21/2028 (3 years past base patent expiry)
Summary: A prodrug helps humans metabolize an inactive drug base compound once it enters the body. This type of prodrug has accompanied nucleoside treatments for decades. Since sofosbuvir is a nucleoside, using this type of prodrug was an obvious choice to activate the basic molecule. Gilead’s two main prodrug patents extend its monopoly by four years to 2029.
Grounds: Anticipation and Obviousness
Petitions: 1

 

Patent Number: 8,334,270

Patent Type: Prodrug
Family: Sofia
Expiry: 03/21/2028 (3 years past base patent expiry)
Summary: A prodrug helps humans metabolize an inactive drug base compound once it enters the body. This type of prodrug has accompanied nucleoside treatments for decades. Since sofosbuvir is a nucleoside, using this type of prodrug was an obvious choice to activate the basic molecule. Gilead’s two main prodrug patents extend its monopoly by four years to 2029.
Grounds: Anticipation and Obviousness
Petitions: 1 | 2

Patent Number: 8,633,309

Patent Type: Crystalline Structures
Family: Ross
Expiry: 3/26/2029 (4 years past base expiry)
Summary: Crystalline structures are the solid form of molecules coming together, like how sodium chloride molecules come together to form salt crystals. Pharmaceutical companies like Gilead try to patent as many crystalline formations as possible on a single drug, all of which are inherent in the parent molecule and are not invented. Gilead’s two main crystalline patents extend its monopoly by five years to 2030.
Grounds: Anticipation and Obviousness
Petitions: 1

Patent Number: 9,284,342

Patent Type: Crystalline Structures
Family: Ross
Expiry: 9/13/2030 (5 years past base expiry)
Summary: Crystalline structures are the solid form of molecules coming together, like how sodium chloride molecules come together to form salt crystals. Pharmaceutical companies like Gilead try to patent as many crystalline formations as possible on a single drug, all of which are inherent in the parent molecule and are not invented. Gilead’s two main crystalline patents extend its monopoly by five years to 2030.
Grounds: Obviousness
Petitions: 1

Patent Number: 9,393,256

Patent Type: Combination
Family: Ray
Expiry: 9/14/2032 (7 years past base expiry)
Summary: Harvoni® consists of two compounds covering the active ingredients, sofosbuvir and ledipasvir. Both compounds have individual patents granted on these active ingredients. It is commonly practiced in the industry to combine two active ingredients, particularly in the field of antivirals such as for HIV treatments. Earlier patents already granted on these active compounds, as well as general literature, state that they can be used in combination with other anti-viral HCV compounds. Combination patents are a part of the pharmaceutical industries toolbox for extending patent exclusivity in order to manage the lifecycle of existing products. In this case, Gilead’s combination patent extends its monopoly beyond the base compound of sofosbuvir by seven years and ledipasvir by two years, until 2032.
Grounds: Anticipation and Obviousness
Petitions: 1

Patent Number: 8,889,159

Patent Type: Formulation
Family: Cleary
Expiry: 3/26/2029 (4 years past base expiry)
Summary: It has been standard practice for decades across the pharmaceutical industry to make tablets for oral consumption by mixing the active ingredient with inert materials. This commonly practiced technique allows for large scale manufacturing, maintains a tablet’s physical appearance, improves stability and aids the delivery of the drug in a human. Gilead has obtained a patent by simply claiming that it has combined the active ingredient, Sovaldi®, with various commonly used inert excipients in a particular weight percentage to make a tablet. Given that the percentage range claimed in this patent is common industry standard for making tablets and is already implied by some of Gilead’s earlier patents on Sovaldi®, this is a classic case of how pharmaceutical companies try to extend their patent exclusivity. In this case, Gilead’s tablet patent extends its monopoly beyond the base compound of Sovaldi® by an additional four years to 2029.
Grounds: Novelty and Obviousness
Petitions: 1

 

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